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Clinical oral investigations · 2021
Lactate dehydrogenase (LDH) is a critical intracellular enzyme responsible for anaerobic respiration in pyruvate metabolism which becomes detectable in extracellular spaces after cellular breakdown. This clinical investigation examined the effects of brushing with a test toothpaste containing natural ingredients, i.e., clove (Syzygium aromaticum), aloe vera (Aloe barbadensis), amla (Emblica officinalis), neem (Azadirachta indica), tulsi (Ocimum basillicum), and honey (from Apis mellifera), and 0.96% zinc (zinc oxide, zinc citrate) and 0.76% SMFP (1000 ppm F) in a calcium carbonate base formulated with natural ingredients (Ved Shakti, Colgate Palmolive India) and a fluoride toothpaste containing 0.76% SMFP (1000 ppm F) in a calcium carbonate base (Colgate Cavity Protection, Colgate Palmolive; henceforth control) on salivary LDH in conjunction with the assessments of dental plaque and gingivitis representing oral hygiene parameters. This double-blind, two-cell study enrolled 70 adults (age range 20-59 years). Subjects completed a washout and provided baseline saliva samples for LDH analysis and clinical assessments of dental plaque and gingivitis using the Turesky Modification of Quigley-Hein and Loe-Silness methods respectively. Subjects were randomly assigned to brush their teeth with either the test or control. Post-treatment sample collection and clinical evaluations were conducted after 3 weeks, 6 weeks, and 12 week sof brushing with all assessments conducted 12 h after hygiene. Statistical analyses were conducted independently for each parameter by t-test for within treatment evaluation and analysis of covariance (ANCOVA) for between treatment comparisons. At baseline, treatment groups demonstrated no significant differences for LDH or dental plaque and gingival index scores. Brushing with the test demonstrated progressive reductions in salivary LDH, plaque and gingival index scores over the study duration in comparison to the control. The test demonstrated reductions in LDH of 9.5-15.4% over the study period in comparison to the control representing statistically significant effects (p < 0.05). The test also demonstrated reductions in dental plaque that ranged between 6.4 and 16.2% over the study period and gingivitis reductions that ranged between 8.2 and 23.8% representing statistically significant results (p < 0.05). Brushing with a novel herbal toothpaste demonstrated significant reductions in salivary LDH representing improvements in cellular integrity with concurrent reductions in dental plaque and gingivitis as compared to the control dentifrice. Salivary LDH measurements offer a non-invasive and objective measurement of mucosal cellular integrity complementing other evaluations and clinical assessments such as plaque and gingival index scores.
Phytomedicine : international journal of phytotherapy and phytopharmacology · 2021
Specific treatment for COVID-19 is still an unmet need. Outcomes of clinical trials on repurposed drugs have not been yielding success. Therefore, it is necessary to include complementary approaches of medicine against COVID-19. This study was designed to evaluate the impact of traditional Indian Ayurvedic treatment regime on asymptomatic patients with COVID-19 infection. It is a placebo controlled randomized double-blind pilot clinical trial. The study was registered with Clinical Trial Registry-India (vide Registration No. CTRI/2020/05/025273) and conducted at the Department of Medicine in National Institute of Medical Sciences and Research, Jaipur, India. 1 g of Giloy Ghanvati (Tinospora cordifolia) and 2 g of Swasari Ras (traditional herbo-mineral formulation) and 0.5 g each of Ashwagandha (Withania somnifera) and Tulsi Ghanvati (Ocimum sanctum) were given orally to the patients in treatment group twice per day for 7 days. Medicines were given in the form of tablets and each tablet weighed 500 mg. While, Swasari Ras was administered in powdered form, 30 min before breakfasts and dinners, rest were scheduled for 30 min post-meals. Patients in the treatment group also received 4 drops of Anu taila (traditional nasal drop) in each nostril every day 1 h before breakfast. Patients in the placebo group received identical-looking tablets and drops, post randomization and double blinded assortments. RT-qPCR test was used for the detection of viral load in the nasopharyngeal and oropharyngeal swab samples of study participants during the study. Chemiluminescent immunometric assay was used to quantify serum levels of interleukin-6 (IL-6), tumor necrosis factor alpha (TNF-α) and high sensitivity C-reactive protein (hs-CRP) on day 1 and day 7 of the study. By day 3, 71.1 % and 50.0 % patients recovered in the treatment and placebo groups, respectively. Treatment group witnessed 100 % recovery by day 7, while it was 60.0 % in the placebo group. Average fold changes in serum levels of hs-CRP, IL-6 and TNF-α in treatment group were respectively, 12.4, 2.5 and 20 times lesser than those in the placebo group at day 7. There was 40 % absolute reduction in the risk of delayed recovery from infection in the treatment group. Ayurvedic treatment can expedite virological clearance, help in faster recovery and concomitantly reduce the risk of viral dissemination. Reduced inflammation markers suggested less severity of SARS-CoV-2 infection in the treatment group. Moreover, there was no adverse effect observed to be associated with this treatment.
International journal of dental hygiene · 2021
This clinical investigation examined the effects of brushing with a test toothpaste containing natural ingredients, that is, clove (Syzgium Aromaticum), aloe vera (Aloe Barbadensis), amla (Emblica Officinalis), neem (Azadirachta Indica), tulsi (Ocimum Basillicum) and honey (from Apis Mellifera) along with zinc salts and fluoride in comparison with a dentifrice formulated with fluoride alone on dental plaque and gingivitis over a 6-month period. One hundred and eighty (180) subjects with mean plaque index scores greater than 1.5 (Turesky Modified Quigley Hein Plaque Index) and gingival index scores >1.0 (Loe and Silness gingival index) in good general health and who met other study criteria were enrolled in the clinical study. Subjects were evaluated for plaque and gingival index scores and were randomly assigned to perform twice-daily oral hygiene with either the test or the control toothpaste for the next 6 months. One hundred and fifty (150) subjects [test toothpaste (n = 72) and control toothpaste (n = 78)] completed the 6-month clinical study with evaluable data. Post-treatment assessments identical to baseline were conducted after 3-month and 6-month use of an assigned product after subjects refrained from oral hygiene for 12 h prior to each evaluation. Comparisons of the treatment groups with respect to baseline-adjusted gingival, plaque, and bleeding index scores at the follow-up examinations were performed using analyses of covariance (ANCOVA). All statistical tests of hypotheses were two-sided and employed a level of significance of p < 0.05. No significant intergroup differences were noted between treatment groups for age and gender by two-sample t-test and chi-square analyses, respectively (p > 0.05). Furthermore, the treatment groups demonstrated no differences at baseline for plaque, gingival and bleeding index scores by a two-sample t-test (p > 0.05). At 3-month and 6-month examination, the test toothpaste exhibited progressive reductions in plaque, gingival and bleeding scores as compared to control toothpaste as showed by ANCOVA (p < 0.001). In comparison with the control, the test demonstrated reductions in 23.5%, 25.6%, and 73.3% for dental plaque, gingival index and bleeding index outcomes, respectively, at the final visit. Reductions in the frequencies of sites with higher clinical scores were noted over the study with more sites registering improvements in the test group than in the control group. Routine oral hygiene with the test toothpaste formulated with herbal ingredients and zinc demonstrated a clinical adjunctive improvement in oral hygiene and parameters of gingival health as compared to brushing with a fluoride toothpaste.
Phytotherapy research : PTR · 2021
Traditional Indian medical practices (Ayurveda, Siddha, Unani, and homeopathy) are a vast reservoir of knowledge about medicinal plants. The promising pharmacological properties of these plants have paved the way for developing therapy against novel Coronavirus (CoV) infection. The current review will summarize published works of literature on the effects of traditional Indian medicinal plants against acute respiratory infection (COVID-19, SARS, Influenza, and Respiratory syncytial virus infection) and registered clinical trials of traditional Indian herbal medicines in COVID-19. The current study aims to comprehensively evaluate the data of traditional Indian medicinal plants to warrant their use in COVID-19 management. PubMed, Embase, and Cochrane databases were searched along with different clinical trial databases. A total of 22 relevant traditional Indian medicinal plants (35 relevant studies) were included in the current study having potential antiviral properties against virus-induced respiratory illness along with promising immunomodulatory and thrombolytic properties. Further, 36 randomized and nonrandomized registered clinical trials were also included that were aimed at evaluating the efficacy of herbal plants or their formulations in COVID-19 management. The antiviral, immunomodulatory, and thrombolytic activities of the traditional Indian medicinal plants laid down a strong rationale for their use in developing therapies against SARS-CoV-2 infection. The study identified some important potential traditional Indian medicinal herbs such as Ocimum tenuiflorum, Tinospora cordifolia, Achyranthes bidentata, Cinnamomum cassia, Cydonia oblonga, Embelin ribes, Justicia adhatoda, Momordica charantia, Withania somnifera, Zingiber officinale, Camphor, and Kabusura kudineer, which could be used in therapeutic strategies against SARS-CoV-2 infection.
Current neuropharmacology · 2023
Alzheimer's is a chronic neurodegenerative disease where amyloid-beta (Aβ) plaques and neurofibrillary tangles are formed inside the brain. It is also characterized by progressive memory loss, depression, neuroinflammation, and derangement of other neurotransmitters. Due to its complex etiopathology, current drugs have failed to completely cure the disease. Natural compounds have been investigated as an alternative therapy for their ability to treat Alzheimer's disease (AD). Traditional herbs and formulations which are used in the Indian ayurvedic system are rich sources of antioxidant, anti-amyloidogenic, neuroprotective, and anti-inflammatory compounds. They promote quality of life by improving cognitive memory and rejuvenating brain functioning through neurogenesis. A rich knowledge base of traditional herbal plants (Turmeric, Gingko, Ashwagandha, Shankhpushpi, Giloy, Gotu kola, Garlic, Tulsi, Ginger, and Cinnamon) combined with modern science could suggest new functional leads for Alzheimer's drug discovery. In this article Ayurveda, the ancient Indian herbal medicine system based on multiple clinical and experimental, evidence have been reviewed for treating AD and improving brain functioning. This article presents a modern perspective on the herbs available in the ancient Indian medicine system as well as their possible mechanisms of action for AD treatment. The main objective of this research is to provide a systematic review of herbal drugs that are easily accessible and effective for the treatment of AD.
Explore (New York, N.Y.) · 2024
Osteoarthritis (OA) is a joint disease characterized by pain, inflammation, and physical disability. Boswellia serrata (BS) is widely studied for its effectiveness in OA condition. Our systematic review and meta-analysis study was aimed to evaluate BS extract efficacy in OA. A sub-group analysis was performed to compare the efficacy of a standardized BS extract (AflapinⓇ) with other BS extracts. Randomized controlled trials, identified from three online databases, evaluating the effect of BS extracts in OA were included. Quality of studies was assessed using PEDro scale and risk of bias was assessed using Cochrane Risk of Bias tool. Pooled effect was reported as mean difference (MD) and 95% confidence interval. Study was conducted as per the Cochrane guidelines (PROSPERO registration ID: CRD42023411356). Nine RCTs with 712 participants were included. All studies (except one) were good quality studies. BS supplementation significantly reduced VAS (MD: -10.71; p<0.00001), LFI (MD: -2.99; p<0.00001), WOMAC-pain (MD: -10.69; p<0.0001), WOMAC-stiffness (MD: -5.49; p<0.00001), and WOMAC-function (MD: -10.69; p<0.00001) scores compared to control therapy. By sub-group analysis, AflapinⓇ supplementation showed greater reduction in VAS (MD: -16.09 vs -4.68), LFI (MD: -3.81 vs -2.01), WOMAC-pain (MD: -18.68 vs -7.07), WOMAC-stiffness (MD: -14.25 vs -3.78), and WOMAC-function (MD: -14.99 vs -8.41) scores as compared to other BS therapies. BS supplementation is effective OA symptomatic management. Sub-group analysis revealed that AflapinⓇ supplementation may be better in improving the symptoms of OA which needs to be confirmed by more comparative clinical studies.
The journal of sexual medicine · 2024
Intravesical instillation of hyaluronic acid (HA) has been associated with reduced sexual dysfunction in participants with recurrent urinary tract infections (rUTIs), but the efficacy of an oral treatment has never been investigated. To investigate the efficacy of an oral preparation of HA, chondroitin sulfate, N-acetylglucosamine, and vitamin C in improving sexual and urinary symptoms in a cohort of reproductive-age participants with rUTI. In a monocentric randomized crossover pilot trial, participants with rUTI who were referred to our institute between March 2022 and April 2023 were randomized 1:1 in 2 groups: intervention vs control. All participants had an oral preparation of cranberry, D-mannose, propolis extract, turmeric, and Boswellia twice a day for 3 months. The intervention group also included an oral preparation of HA, chondroitin sulfate, N-acetylglucosamine, and vitamin C once a day for 3 months. Crossover of treatment occurred at 3 months for an additional 3 months. At baseline and 3 and 6 months, participants were evaluated clinically and with the International Prostate Symptom Score (IPSS) and Female Sexual Function Index (FSFI). Descriptive statistics and logistic regression models tested the impact of the intervention on urinary and sexual symptoms at each follow-up assessment. Improvement in sexual and urinary symptoms as measured by the FSFI and IPSS. Overall, 27 (54%) participants had an FSFI score <26.5 at enrollment. At 3 months, FSFI scores were higher in the intervention group vs control (P < .001), but IPSS scores were lower (P = .03). After crossover of treatment, FSFI and IPSS scores remained stable in the intervention group. However, after crossover, the control group showed a significant improvement in IPSS and FSFI scores (all P < .01) vs the 3-month assessment. At last follow-up, urinary and sexual symptoms were comparable between groups. In logistic regression analyses, the intervention group was associated with early improvement in sexual symptoms (odds ratio, 3.9; P = .04) and urinary symptoms (odds ratio, 5.1; P = .01) after accounting for clinical confounders. Combination treatment with HA, chondroitin sulfate, N-acetylglucosamine, and vitamin C is effective if started immediately or even after a few months from symptoms in participants with rUTI. The main limitation is the lack of long-term follow-up. The oral formulation of HA, chondroitin sulfate, N-acetylglucosamine, and vitamin C could be an effective therapy against urinary and sexual distress in participants with rUTI (NCT06268483; ClinicalTrials.gov).
Terapevticheskii arkhiv · 2023
To evaluate the efficacy of Artneo (AN) in comparison with a combination of glucosamine hydrochloride and chondroitin sulfate (GC) in patients with osteoarthritis (OA) of the knee joint (KJ). 70 patients with stages I-III of primary knee OA were randomized into 2 groups. Participants in the 1st (n=35) took AN 1 caps/day, in the 2nd (n=35) GC according to the standard regimen. After 7, 30, 90, 180 days, the Lequesne index (severity of OA), pain when moving according to VAS, WOMAC score were assessed, after 1, 3, 6 months - quality of life SF-36 and morning stiffness, after 6 months - MRI with T2 mapping, laboratory safety indicators. Over the course of 6 months of use, an improvement in the WOMAC index and a decrease in pain were observed without intergroup differences, and a greater decrease in stiffness in the AN group. After 3 months, the severity of OA decreased from moderate to mild in the AN group and was significantly lower compared to the GC group; quality of life (physical component of SF-36) was higher in the AN group. After 6 months, there was an improvement in cartilage ultrastructure (T2 relaxation time) in both groups and a more pronounced reduction of the synovitis area (MRI) in the AN group (2.95 and 1.37 times in the AN and GC group, respectively). There were no clinically significant adverse reactions observed in both groups. The use of AN in patients with stage I-III primary knee OA was not inferior in efficacy to the combination of GC. Further studies with greater statistical power (sample size) and follow-up period are warranted including in real clinical practice. Цель. Оценить эффективность Артнео (АН) в сравнении с комбинацией глюкозамина гидрохлорида и хондроитина сульфата (ГХ) у больных остеоартритом (ОА) коленного сустава (КС). Материалы и методы. В исследовании 70 пациентов с I–III стадиями первичного ОА КС рандомизированы на 2 группы. В 1-й (n=35) группе участники принимали АН по 1 капсуле в сутки, во 2-й (n=35) – ГХ по стандартной схеме. Через 7, 30, 90, 180 дней оценивали индекс Лекена (тяжесть ОА), боль при движении по Визуальной аналоговой шкале, индекс WOMAC, через 1, 3, 6 мес – качество жизни по физическому компоненту SF-36 и утреннюю скованность, через 6 мес проводили магнитно-резонансную томографию с T2-картированием, оценивали лабораторные показатели безопасности. Результаты. На протяжении 6 мес в обеих группах наблюдали улучшение индекса WOMAC и уменьшение боли. Большее снижение утренней скованности отмечали в группе АН. Через 3 мес тяжесть ОА уменьшилась с умеренной до слабой в группе АН и оказалась значимо ниже по сравнению с группой ГХ, а качество жизни по SF-36 было выше в группе АН. Через 6 мес отмечены улучшение ультраструктуры хряща (время T2-релаксации) в обеих группах и более выраженное снижение площади синовита в группе АН (в 2,95 и 1,37 раза в группах АН и ГХ соответственно). Клинически значимых нежелательных реакций не отмечено ни в одной из групп. Заключение. Применение АН у пациентов с первичным ОА КС I–III стадии не уступало по эффективности комбинации ГХ. Целесообразно проведение дальнейших исследований с большей статистической мощностью (размером выборки) и более длительным периодом наблюдения, в том числе в условиях реальной клинической практики.
Chinese journal of integrative medicine · 2024
The discovery of novel antitumor agents derived from natural plants is a principal objective of anticancer drug research. Frankincense, a widely recognized natural antitumor medicine, has undergone a systematic review encompassing its species, chemical constituents, and diverse pharmacological activities and mechanisms. The different species of frankincense include Boswellia serrata, Somali frankincense, Boswellia frereana, and Boswellia arabica. Various frankincense extracts and compounds exhibit antitumor, anti-inflammatory, and hepatoprotective properties and antioxidation, memory enhancement, and immunological regulation capabilities. They also have comprehensive effects on regulating flora. Frankincense and its principal chemical constituents have demonstrated promising chemoprophylactic and therapeutic abilities against tumors. This review provides a systematic summary of the mechanism of action underlying the antitumor effects of frankincense and its major constituents, thus laying the foundations for developing effective tumor-combating targets.
Annali italiani di chirurgia · 2024
We investigated the potential benefits of administering a nutraceutical combination of Bromelain (200 mg) and Boswellia serrata Casperome® (200 mg) on post-operative outcomes of hernioplasty with mesh. One hundred eighty patients (27 females, 153 males) were enrolled to undergo open tension-free hernioplasty with the use of Progrip®. Patients were randomized to receive either one tablet of Siben® (study group) or placebo (control group) on an empty stomach, every twelve hours for eleven postoperative days. All patients filled out a medical questionnaire focused on postoperative pain, based on the Visual Analogue Scale (VAS) scale and the Short Form-36 (SF-36) questionnaire, at time T0 (day of surgery) and T28 (28th day after surgery). One-year results showed a significant improvement in the primary postoperative outcome in the study group. Perception of pain was significantly reduced in the Siben® group compared with controls, both on the seventh (p < 0.05) and the twenty-first (p < 0.05) postoperative day. Patients included in the Siben® group also resumed daily activities and returned to work earlier than the controls. Moreover, results of the SF-36 indicated better Quality of Life (QoL) scores in the study group compared to the placebo group. Our analysis effectively demonstrates that the use of Siben® in open inguinal hernia mesh repair may improve short- and long-term surgical outcomes, contributing to a better QoL.
Journal of complementary & integrative medicine · 2024
Temporomandibular disorders (TMDs) are usually treated with occlusal appliances and supportive treatments such as physical therapy and drugs. Supplements can be included among potential supportive therapies, with the aim of reducing the use of drugs. To evaluate the efficacy of nutraceuticals' short-term treatment in subjects with temporomandibular disorders. The study started in January 2021 and ended in January 2022. Subjects with temporomandibular disorders and a verbal numeric scale >40 were recruited and randomly assigned to one of the following groups. If waiting to start a therapy, to the nutraceutical group or to the no treatment group, while if already undergoing splint therapy, to nutraceautical+splint group or to splint therapy group. Nutraceutical used was composed by Boswellia Serrata Casperome, Magnesium, Tryptophan and vitamins B2 and D with a posology of one tablet/day before sleep for 40 days. Presence of temporomandibular pain, headache, neck pain and sleep/emotional disorders were assessed at T0 and at T1, after 40 days. ANOVA was performed to compare treatments with nutraceuticals and their respective controls, as for the variables related to painful symptomatology. Chi-squared was conducted to assess differences in sleep/emotional disorders between groups. The statistical significance was p<0.05. The groups using nutraceuticals showed statistically significant improvements over controls for most of the variables analyzed. The use of nutraceutical seems to be a valuable support for TMD therapy in the short term either alone or combined with occlusal splint therapy.
Phytotherapy research : PTR · 2024
Knee osteoarthritis (OA) has recently been ranked as the 11th highest contributor to global disability. More than 40% of patients use complementary and alternative medicine including supplements containing phytoextracts with anti-inflammatory properties as those from the Boswellia genus. The aim of this meta-analysis was to evaluate the efficacy of phytoextracts from the oleogum resin of the Boswellia genus as supplementation for patients affected by knee OA. Four electronic databases were used for the research and PRISMA statements were followed throughout the study. The following inclusion criteria were used: (a) the subjects of the study were humans with a diagnosis of knee OA reported by medical staff; (b) randomization and the presence of control (placebo, negative or positive control), and (c) outcomes reported with WOMAC and/or visual analog scale (VAS) score. Publication bias was assessed with a funnel plot and through the Egger test. The Jadad scale was used in order to assess the quality of the studies included. The statistical heterogeneity was assessed using I2 statistics. Results of meta-analysis and subgroup analysis were reported using a forest plot. A total of 13 studies involving 850 (WOMAC) and 1185 (VAS) patients met the inclusion criteria. The meta-analysis did not detect a significant effect of the use of Boswellia extracts between the control and the treatment groups due to the high heterogeneity of the studies (p = 0.0865 for WOMAC) and (p = 0.3966 VAS). However, the subsequent subgroup analysis demonstrated the significant beneficial effect of Boswellia extracts in the treatment of knee OA with respect to a placebo (lower WOMAC score in the treatment groups). This was also confirmed in the meta-regression applied to the WOMAC scores. This is an important finding as people exposed to NSAID-related adverse effects could benefit from the use of Boswellia extracts. However, further high-quality studies are needed to establish the clinical efficacy of extracts from the genus Boswellia.
Journal of medicinal food · 2024
Osteoarthritis is one of the most common locomotor diseases, with a steadily increasing prevalence and incidence. Loxacon® is a food supplement capsule containing vitamins, minerals, and herbal extracts with Boswellia serrata extract and Harpagophytum procumbens extract as its two main active components. The study involved 88 patients at 4 sites. The 88 patients were divided into 3 groups. The first group received physical therapy and Loxacon® capsules for 5 weeks, while the second group (30 patients) received physical therapy only for 5 weeks, and the third group (30 patients) received physical therapy and placebo capsules for 5 weeks. After 5 weeks, physical therapy was discontinued in all three groups and all groups continued Loxacon® capsules exclusively for an additional 60 days. Physical therapy had been carried out by a standard protocol over 5 weeks. Investigated parameters included Western Ontario and McMaster Universities Arthritis Index (WOMAC) testing, European Quality of Life (EQ-5D-5L) quality of life test and the Range of Motion (ROM). Among the 4 visual analogue scale (VAS) values investigated from WOMAC, significant change was seen for functionality in all three groups; however, the extent of change was twice as large in the physical therapy + Loxacon® group at Visit 2 in comparison with the other two groups. In the physical therapy + placebo group, improvement was seen only at the 3rd visit when they were also receiving Loxacon® capsules. The most pronounced difference was seen in the minimum clinically important difference index, calculated from the quality of life-VAS, where those taking Loxacon® capsules had a chance 3 times as high to obtain clinical improvement versus the other two groups. Our study confirmed that a combination of boswellic acid and harpagosides is beneficial as an additional therapy in knee OA.
Frontiers in clinical diabetes and healthcare · 2024
Type 2 diabetes mellitus (T2DM) is a significant global health challenge whose prevalence is projected to increase alarmingly. Recently, due to better safety and fewer adverse effects, herbal medicines have been used to manage T2DM. This study aimed to evaluate the efficacy of boswellia in improving glycemic markers and lipid profiles in T2DM patients. A comprehensive search was conducted on the PubMed, Web of Science, and Scopus databases for all relevant studies published up to April 30, 2024. The effects of boswellia supplementation were evaluated using glycemic markers and lipid profiles. The data were extracted and meta-analyzed using Stata software. This meta-analysis included five studies with a total of 287 patients with T2DM. It was found that boswellia in patients with T2DM compared to the placebo or control group significantly reduced hemoglobin A1C (HbA1C) (SMD: -1.01; 95%CI: -1.55 to -0.46; P=0.00), total cholesterol (TC) (SMD: -0.44; 95%CI: -0.68 to -0.21; P=0.00), Triglycerides (TG) (SMD: -0.42; 95%CI: -0.66 to -0.19); P=0.00) and low-density lipoprotein (LDL) (SMD: -0.43; 95%CI: -0.73 to -0.12); P=0.006) levels, while reduced fasting blood glucose (FBG) but it was not significant (SMD: -1.34, 95%CI: -2.68 to 0.00; P=0.05). Notably, it did not affect high-density lipoprotein (HDL) (SMD: 0.56, 95%CI: -0.14 to -1.26; P=0.118). In summary, boswellia supplementation has the potential to improve glycemic markers and lipid profiles in patients with T2DM. It may help diabetic patients in addition to a controlled diet and other treatments. crd.york.ac.uk/PROSPERO/display_record.php?RecordID=538347, identifier CRD42024538347.
Journal of the American Nutrition Association · 2025
Boswellia serrata Roxb. ex Colebr. (Family: Burseraceae; Genus: Boswellia) gum resin (Salai guggul) has profound therapeutic value in Ayurvedic and Unani medicines in alleviating several chronic inflammatory illnesses, including arthritis, asthma, skin and blood diseases, fever, etc. SN13108F (Aflapin®) is a proprietary, standardized Boswellia serrata gum resin extract. This 180-day randomized, placebo-controlled clinical study aimed to evaluate cartilage morphology using magnetic resonance imaging (MRI), pain and joint function and long-term safety in the SN13108F-supplemented volunteers with knee osteoarthritis (KOA). Eighty adult male and female subjects with the Kellgren-Lawrence grade II - III KOA were supplemented with SN13108F (100 mg/day) or a matched placebo for 180 consecutive days. SN13108F reduced (p < 0.001; vs. baseline and placebo) Western Ontario and McMaster Universities Osteoarthritis Index, Visual Analogue Scale, Lequesne's Functional Index scores, improved six-minute walk test, and stair climb test. Post-trial MRI assessments of the tibiofemoral joints revealed that the cartilage volume, thickness, and joint space width were increased (p < 0.001; vs. placebo), and levels of high-sensitivity C-reactive protein, matrix metalloproteinase-3, Fibulin-3, type II collagen degradation peptide in serum, and cross-linked C-terminal telopeptide of type II collagen in urine were significantly reduced (p < 0.001; vs. baseline and placebo) in the SN13108F-supplemented subjects. Hematology, complete serum biochemistry, urine analysis, and the participants' vital signs did not alter between the groups. SN13108F supplementation is safe, and it mitigates joint pain and improves musculoskeletal function and cartilage morphology in KOA.
Explore (New York, N.Y.) · 2025
Chronic lower back pain (CLBP) is a major condition that leads to disability and reduced quality of life (QoL). This randomised, double-blind, placebo-controlled clinical study evaluated the efficacy and safety of a novel Boswellia serrata and Curcuma longa combination (CL20192) for the treatment of CLBP. Participants with CLBP were randomised to receive either a 300 mg CL20192 capsule (n = 45) or placebo capsule (n = 45) once daily for 90 days. Efficacy was evaluated using the Descriptor Differential Scale and Oswestry Disability Index scores for pain, unpleasantness, and disability. Additionally, the 36-item short form questionnaire was used for QoL evaluation. Frequency of painkiller use, serum levels of inflammatory biomarkers (tumour necrosis factor-α, interleukin-6, and high-sensitivity C-reactive protein), and phytoconstituents (total boswellic acids and curcuminoids) were determined. Therapy satisfaction was assessed using the Physician and Patient Global Assessment Scales. All randomised participants completed the study. CL20192 supplementation significantly reduced Descriptor Differential Scale pain, unpleasantness, and Oswestry Disability Index scores compared with the placebo group (p < 0.001 for all parameters). Critical QoL scores greatly improved in the CL20192 group. Serum phytoconstituent levels were elevated in the CL20192-treated group. This group demonstrated a significant reduction in inflammatory biomarker levels (tumour necrosis factor-α, interleukin-6, and high-sensitivity C-reactive protein), confirming efficacy in abating CLBP compared with the placebo. Moreover, therapy satisfaction scores were significantly high in the CL20192-treated group, and intervention with CL20192 was well tolerated. Intervention with 300 mg CL20192 capsules, containing a novel combination of Boswellia serrata and Curcuma longa extracts, effectively alleviated pain, unpleasantness, and disability in patients with CLBP compared with the placebo. This outcome was consistent with a decrease in serum inflammatory markers and improved therapy assessment scores.
Pharmaceutical research · 2025
Osteoarthritis is the prevailing form of inflammatory condition in joints of adults and the aging population, leading to long-term disability and chronic pain. Current therapeutic options have variable therapeutic efficacy and/or several side effects. A randomized, placebo-controlled, double-blind clinical trial was conducted in 62 participants using a nutraceutical [standardized Boswellia serrata Roxb. gum resin (300 mg) and Apium graveolens L. seed extract (250 mg)], to determine its safety and efficacy for supporting cartilage health and reduction in knee osteoarthritis symptoms. All participants were assessed for physical function and pain with the help of WOMAC, VAS, Physicians' Global Assessment for the six-minute walk test/pain. Knee X-ray, KOOS questionnaire score, and FACIT-F score were assessed. Additionally, inflammatory, cartilage degeneration and regeneration biomarkers in serum and urine were evaluated at baseline and after 90 days of treatment. Oral administration of the nutraceutical resulted in prolonged symptomatic relief with reduced pain, stiffness, and swelling. Inflammatory (serum IL-7, IL-1, IL-6, hs-CRP, TNF-α, ESR) and cartilage degeneration biomarkers (serum CTX-II, COMP, MMP-3 and urinary CTX-II) were decreased in the nutraceutical group compared to baseline and placebo. Furthermore, serum N-propeptide of collagen IIA (PIIANP) and procollagen-type-C propeptide (PIICP) levels were increased in the nutraceutical group, suggesting collagen synthesis contributing to cartilage regeneration. At given doses for 90 days, there were no adverse effects based on the clinical examination, biochemical, hematological, and ECG analysis. Taken together, the combination of Boswellia and celery could be a safe and promising herbal nutraceutical option for managing osteoarthritis and cartilage health effectively.
Scientific reports · 2025
Aim of study is to analyze Bromelain' effects on the most common early complications after BCS (oedema and seroma). From January 2021 to December 2023 a double-blind randomized placebo-controlled trial was performed on 114 candidates for BCS at our Academic Unit. Group A received a supplement of Casperome™-Boswellia Phytosome® + Bromelain (CBB) in combination with alpha-lipoic acid + superoxide dismutase + B and D vitamins + centella asiatica. Group B received a supplement of CBB + placebo. Group C received placebo. The therapies were administrated for 30 days. On GEE logistic regression, drugs combination in A seems to be associated with statistical fewer oedema compared with C (P = 0.018 at 1 day and P = 0.002 after 1 month). Comparing B to C, B gained a significative value after 1 month (P = 0.007). On GEE logistic regression, the drugs combination in A has been associated with statistical fewer seroma compared with C (P = 0.009 at 15thpostoperative day and P < 0.001 after 1 month). B vs C reaches significant values 15 day and 1 month after surgery (P = 0.002 and P < 0.001, respectively). The current study is the first analyzing the employment of CBB association with/without neurotrophic agent on prevention of early complications after BCS.
Journal of back and musculoskeletal rehabilitation · 2025
BackgroundPoor posture from work or lifestyle habits is a common cause of low back soreness and discomfort. This study investigates the potential of Rhuleave-K, a turmeric-Boswellia formulation for managing these symptoms.ObjectiveTo evaluate the efficacy of Rhuleave-K (500 mg) over 15 days in alleviating posture-related low back soreness and discomfort in human participants.MethodsThis randomized, placebo-controlled, double-blinded, parallel arm study involved 52 subjects aged 18-70 years, with an equal male to female ratio of 1:1, and a 15 days intervention period. The inclusion criteria were a posture-related low back soreness and discomfort for at least 2-3 weeks with a pain intensity of greater than or equal to 5 on numerical rating scale. The primary outcome measure was a pain intensity difference from baseline to day 7 and day 15. Secondary outcome measures were a categorical pain relief scale and Oswestry disability index (ODI).ResultsThere was a significant decrease in the pain intensity (p < 0.001) compared to placebo at the end of 15 days of study in the Rhuleave-K group. After 7 days of supplementation of Rhuleave-K, there was a 56% reduction in pain intensity and by the end of the study, there was 98.5% reduction. In the responder profile of those having greater than or equal to 50% of max total pain relief, all 26 was in Rhuelave-K group and 3 were in placebo group. The ODI had significant 27% and 98% reduction in the disability index at day 7 and 15 respectively for Rhuleave-K group and placebo group had 1% and 3% change.ConclusionPosture-related low back soreness and discomfort was significantly reduced by Rhuleave-K at 500 mg dose. It is hence evident from this study's outcome that the Rhuleave-K can be a safe and effective alternative for the short-term management of lower back discomfort.
Osteoarthritis and cartilage · 2025
To evaluate the efficacy and safety of a combination of patented C. longa and B. serrata extracts (CBTIL) in patients with hand osteoarthritis compared with placebo. This 3-month, multicentre, randomized, double-blind, placebo-controlled study enrolled patients with symptomatic hand osteoarthritis, with a body mass index ≤ 35 Kg/m2, and who met the American College of Rheumatology criteria for osteoarthritis of the hand (CUBO/NCT05570123). Participants received either two tablets of CBTIL or two placebo tablets per day. The primary endpoint was the difference in pain change on the visual analog scale between baseline and month 3. Secondary outcomes included the number of painful and swollen joints, functional score, quality of life, patient global assessment, grip strength, analgesic consumption, and treatment tolerance. 162 patients were randomly assigned to receive CBTIL (n=83) or placebo (n=79). In the Intention-to-treat analysis, the mean decrease (indicating pain relieve) from baseline to month 3 on the pain scale (primary endpoint) was -24.7 mm (95% Confidence Interval (CI) [-30.7 to -18.7]) in patient assigned to CBTIL group and -16.2 mm (95% CI [-22.5 to -9.9]) in patients assigned in placebo group (Difference between groups: -8.5 mm (95% CI [-16.4 to -0.6]; p = 0.03). At 3 months, the patient's global assessment (-9.6 mm [95% CI -16.9 to -2.2]), the percentage of patients achieving an acceptable symptom status (PASS) (Odd ratio (OR) 1.9 [95% CI 1.0 to 3.8]), Short Form-36 (SF-36) pain (7.1 units [95% CI 1.7 to 12.4]), and SF36 health change (6.7 units [95% CI 1.2 to 12.2]) were significantly improved by CBTIL compared to placebo. Other outcomes did not significantly differ between the two groups. No significant difference was observed regarding adverse events between the groups. CBTIL relieves pain in patients with hand osteoarthritis. Together with its safety, this clinically relevant symptomatic effect suggests that CBTIL may be an alternative to oral NSAIDs and analgesics for managing symptomatic hand osteoarthritis.