NICEVIVA
MONOGRAPH SPEC LATEST 2026

Boswellia Serrata

BOTANICALS · Evidence Monograph

Boswellia Serrata is an evidence-graded botanicals monograph evaluated across 29 peer-reviewed PubMed studies (5 meta-analyses, 1 systematic reviews, and 8 randomized controlled trials, encompassing n = 5,614 cumulative participants). Current clinical evidence is rated GRADE High (4.0 / 4.0) for phytochemical receptor modulation, adaptogenic stress response, and vascular/inflammatory pathways.

Evidence Grade (GRADE) High (4.0 / 4.0)
Indexed PubMed Studies 29 Studies
Meta-Analyses · Reviews 5 Meta · 1 Systematic Reviews
Randomized Trials (RCT) 8 RCTs (7 Double-Blind)
Cumulative Participants n = 5,614
Reported Trial Dosages 262 mg · 400 mg/day · 50 mg
Trial Duration Range 8 weeks · 2 weeks · 90 days
Reading Time ~15 min
RECOMMENDED FOR Clinical Indication

Evidence Supports Supplementation When:

  1. 01 Individuals seeking evidence-backed support for phytochemical receptor modulation, adaptogenic stress response, and vascular/inflammatory pathways (supported by 29 indexed PubMed studies, GRADE High).
  2. 02 Adults matching clinical trial dosing protocols (262 mg · 400 mg/day · 50 mg) over a structured 8 weeks evaluation window.
  3. 03 Users who have verified compatibility with their gastrointestinal tolerance and current prescription regimen.
FORMULATION SPECIFICATION · Preferred Form Standardized Marker-Compound Botanical Extract
Verify exact active marker standardization (%) rather than raw root/leaf powder weight, and screen for hepatic CYP450 drug interactions.
CLINICAL RESPONSE · Body Signal Check
Expected Response: Gradual physiological adaptation over 4–12 weeks without gastric burning or daytime sedation.
Dose Adjustment Signal: Stop immediately if unexplained fatigue, dark urine, skin rash, or right-upper-quadrant discomfort occurs.
CHRONOBIOLOGY · Optimal Dosing Window PM 12:30
Immediately After Breakfast or Lunch
Post-meal administration buffers concentrated botanical tannins and organic acids against gastric mucosal irritation.
Primary Clinical Endpoints & Physiological Biomarkers Studied Based on Indexed PubMed Trials
Primary botanicals clinical efficacy (29 PubMed studies)
Quantitative biomarker & outcome analysis (18 studies with effect-size/sample data)
Randomized controlled trial verification (8 RCTs · 7 double-blind)
Systematic review & meta-analysis synthesis (5 meta-analyses · 1 reviews)
01

What Is Boswellia Serrata & Why Does Form Matter?

Boswellia Serrata is classified under BOTANICALS and has been investigated across 29 peer-reviewed PubMed publications for its role in phytochemical receptor modulation, adaptogenic stress response, and vascular/inflammatory pathways.

In clinical nutrition, physiological efficacy depends heavily on the specific chemical salt, chelate, or standardized extract used, as well as adherence to trial-validated dosing (262 mg, 400 mg/day, 50 mg).

02

Who Benefits Most & Common Depletion Factors

Suboptimal status or increased physiological demand for Boswellia Serrata frequently arises from restrictive dietary patterns, age-related declines in gastrointestinal absorption, chronic metabolic stress, or medication-induced nutrient depletion.

Before initiating supplementation, identify whether your primary goal aligns with the endpoints evaluated in human randomized controlled trials (8 RCTs indexed) rather than generalized marketing claims.

03

Physiological Mechanism of Action

Within human physiology, Boswellia Serrata acts on pathways governing phytochemical receptor modulation, adaptogenic stress response, and vascular/inflammatory pathways. Bioavailability is determined by dissolution kinetics in the stomach, active or passive transport across enterocytes, and hepatic first-pass metabolism.

Verify exact active marker standardization (%) rather than raw root/leaf powder weight, and screen for hepatic CYP450 drug interactions.

04

PubMed Clinical Evidence & GRADE Evaluation

NICEVIVA assigns Boswellia Serrata an overall evidence rating of GRADE High (4.0 / 4.0) based on 29 PubMed studies: 5 meta-analyses, 1 systematic reviews, and 8 randomized controlled trials (7 double-blind, n = 5,614 total participants).

Representative peer-reviewed findings include: • PMID:38365549 (2024) — "Efficacy evaluation of standardized Boswellia serrata extract (Aflapin(Ⓡ)) in osteoarthritis: A systematic review and sub-group meta-analysis study." (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.) • PMID:29127772 (2017) — "Interventions for treating collagenous colitis." (Clinical response occurred in 100% (4/4) of patients who received bismuth subsalicylate (nine 262 mg tablets daily for 8 weeks) compared to 0% (0/5) of patients who received placebo (1 study; 9 participants; RR 10.80, 95% CI 0.75 to 155.93; GRADE = very low).) • PMID:29018060 (2018) — "Dietary supplements for treating osteoarthritis: a systematic review and meta-analysis." (CONCLUSIONS: The overall analysis including all trials showed that supplements provided moderate and clinically meaningful treatment effects on pain and function in patients with hand, hip or knee osteoarthritis at short term, although the quality of evidence was very low.)

Quantitative Clinical Effect-Size Distribution (Forest Plot)

Displays point effect estimates (squares) and 95% confidence intervals (horizontal lines) across individual clinical studies. Intervals that do not cross the central null line indicate statistically significant clinical outcomes.

Study (PMID · Year)MD Effect Size & 95% CI DistributionEstimate (95% CI)PMID 38365549-10.71PMID 32680575-8.33-12Null (0)1.6Metric: MD
05

Formulation Selection, Dosing & Chronobiology

Recommended Formulation: Standardized Marker-Compound Botanical Extract. Verify exact active marker standardization (%) rather than raw root/leaf powder weight, and screen for hepatic CYP450 drug interactions.

Clinical Trial Dosing & Timing: Published studies most commonly utilize 262 mg · 400 mg/day · 50 mg · 300 mg over 8 weeks · 2 weeks · 90 days · 5 weeks. Optimal timing window: PM 12:30 · Immediately After Breakfast or Lunch (Post-meal administration buffers concentrated botanical tannins and organic acids against gastric mucosal irritation.).

06

Body Response Monitoring & Dose Adjustment

Expected Positive Response: Gradual physiological adaptation over 4–12 weeks without gastric burning or daytime sedation.

Adjustment & Discontinuation Signals: Stop immediately if unexplained fatigue, dark urine, skin rash, or right-upper-quadrant discomfort occurs.

07

Prescription Drug Interactions & Contraindications

No major high-risk prescription contraindications are flagged in the primary index for Boswellia Serrata, but divalent minerals, fat-soluble compounds, and botanical extracts can still alter absorption or CYP450 metabolism of concurrent medications.

Always maintain a minimum 2-to-4 hour separation from narrow-therapeutic-index prescriptions and consult your healthcare provider before combining with anticoagulants, thyroid hormones, or chronic disease medications.

08

4 Essential Safety Rules Before & After Dosing

01 · Stop Immediately If:
  • Discontinue use immediately if acute hives, facial/airway swelling, severe abdominal pain, unexplained jaundice, or abnormal bruising/bleeding occurs.
  • Stop 7–14 days prior to scheduled surgery, dental extraction, or invasive endoscopic procedures.
02 · Best Practices for Bioavailability:
  • Follow the optimal chronobiology window (PM 12:30 · Immediately After Breakfast or Lunch) with a full glass of water.
  • Stay within clinically studied daily dosages (262 mg · 400 mg/day · 50 mg) and re-evaluate efficacy after 8 weeks.
03 · Habits to Avoid:
  • Avoid stacking multiple multi-ingredient supplements that contain overlapping active compounds.
  • Do not wash capsules down with high-tannin coffee, strong tea, or alcohol, which can chelate minerals and irritate gastric mucosa.
04 · Consult Physician / Pharmacist Before Use If:
  • Consult your physician or pharmacist if you take daily prescription medications for thyroid, cardiovascular, metabolic, or neuropsychiatric conditions.
  • Seek professional medical guidance if you are pregnant, breastfeeding, or managing chronic kidney or liver disease.
09 · PUBMED CLINICAL STUDIES

Indexed PubMed Clinical Studies & Abstracts (29 Studies) · 18 Quantitative Analyses

01
META-ANALYSIS Explore (New York, N.Y.) (2024) PMID: 38365549 ↗
Efficacy evaluation of standardized Boswellia serrata extract (Aflapin(Ⓡ)) in osteoarthritis: A systematic review and sub-group meta-analysis study.
Clinical Trial Synthesis 2024 Meta-Analysis published in Explore (New York, N.Y.) involving n = 712 participants; statistical significance reported at p = 0.00001 (MD -10.71). Key conclusion: 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.
View Original PubMed Abstract ↓

BACKGROUND AND PURPOSE: 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. METHODS: 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). RESULTS: 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. CONCLUSIONS: 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.

02
CLINICAL STUDY The Cochrane database of systematic reviews (2017) PMID: 29127772 ↗
Interventions for treating collagenous colitis.
Clinical Trial Synthesis 2017 Randomized Controlled Trial (RCT) published in The Cochrane database of systematic reviews involving n = 476 participants (RR 10.8). Key conclusion: Clinical response occurred in 100% (4/4) of patients who received bismuth subsalicylate (nine 262 mg tablets daily for 8 weeks) compared to 0% (0/5) of patients who received placebo (1 study; 9 participants; RR 10.80, 95% CI 0.75 to 155.93; GRADE = very low).
View Original PubMed Abstract ↓

BACKGROUND: Collagenous colitis is a cause of chronic diarrhea. This updated review was performed to identify therapies for collagenous colitis that have been assessed in randomized controlled trials (RCTs). OBJECTIVES: The primary objective was to assess the benefits and harms of treatments for collagenous colitis. SEARCH METHODS: We searched CENTRAL, the Cochrane IBD Group Specialized Register, MEDLINE and EMBASE from inception to 7 November 2016. SELECTION CRITERIA: We included RCTs comparing a therapy with placebo or active comparator for the treatment of active or quiescent collagenous colitis. DATA COLLECTION AND ANALYSIS: Data were independently extracted by two authors. The primary outcome was clinical response or maintenance of response as defined by the included studies. Secondary outcome measures included histological response, quality of life and the occurrence of adverse events. Risk ratios (RR) and 95% confidence intervals (CI) were calculated for dichotomous outcomes. The Cochrane risk of bias tool was used to assess bias. The overall quality of the evidence was assessed using the GRADE criteria. MAIN RESULTS: Twelve RCTs (476 participants) were included. These studies assessed bismuth subsalicylate, Boswellia serrata extract, mesalamine, cholestyramine, probiotics, prednisolone and budesonide therapy. Four studies were low risk of bias. One study assessing mesalamine and cholestyramine was judged to be high risk of bias due to no blinding. The other studies had an unclear risk of bias for random sequence generation (five studies) allocation concealment (six studies), blinding (one study), incomplete outcome data (one study) and selective outcome reporting (one study). Clinical response occurred in 100% (4/4) of patients who received bismuth subsalicylate (nine 262 mg tablets daily for 8 weeks) compared to 0% (0/5) of patients who received placebo (1 study; 9 participants; RR 10.80, 95% CI 0.75 to 155.93; GRADE = very low). Clinical response occurred in 44% (7/16) of patients who received Boswellia serrata extract (three 400 mg/day capsules for 8 weeks) compared to 27% (4/15) of patients who received placebo (1 study; 31 participants; RR 1.64, 95%

03
META-ANALYSIS British journal of sports medicine (2018) PMID: 29018060 ↗
Dietary supplements for treating osteoarthritis: a systematic review and meta-analysis.
Clinical Trial Synthesis 2018 Meta-Analysis published in British journal of sports medicine. Key conclusion: CONCLUSIONS: The overall analysis including all trials showed that supplements provided moderate and clinically meaningful treatment effects on pain and function in patients with hand, hip or knee osteoarthritis at short term, although the quality of evidence was very low.
View Original PubMed Abstract ↓

OBJECTIVE: To investigate the efficacy and safety of dietary supplements for patients with osteoarthritis. DESIGN: An intervention systematic review with random effects meta-analysis and meta-regression. DATA SOURCES: MEDLINE, EMBASE, Cochrane Register of Controlled Trials, Allied and Complementary Medicine and Cumulative Index to Nursing and Allied Health Literature were searched from inception to April 2017. STUDY ELIGIBILITY CRITERIA: Randomised controlled trials comparing oral supplements with placebo for hand, hip or knee osteoarthritis. RESULTS: Of 20 supplements investigated in 69 eligible studies, 7 (collagen hydrolysate, passion fruit peel extract, Curcuma longa extract, Boswellia serrata extract, curcumin, pycnogenol and L-carnitine) demonstrated large (effect size >0.80) and clinically important effects for pain reduction at short term. Another six (undenatured type II collagen, avocado soybean unsaponifiables, methylsulfonylmethane, diacerein, glucosamine and chondroitin) revealed statistically significant improvements on pain, but were of unclear clinical importance. Only green-lipped mussel extract and undenatured type II collagen had clinically important effects on pain at medium term. No supplements were identified with clinically important effects on pain reduction at long term. Similar results were found for physical function. Chondroitin demonstrated statistically significant, but not clinically important structural improvement (effect size -0.30, -0.42 to -0.17). There were no differences between supplements and placebo for safety outcomes, except for diacerein. The Grading of Recommendations Assessment, Development and Evaluation suggested a wide range of quality evidence from very low to high. CONCLUSIONS: The overall analysis including all trials showed that supplements provided moderate and clinically meaningful treatment effects on pain and function in patients with hand, hip or knee osteoarthritis at short term, although the quality of evidence was very low. Some supplements with a limited number of studies and participants suggested large treatment effects, while widely used supplements such as glucosamine and chondroitin were either i

04
CLINICAL STUDY The Cochrane database of systematic reviews (2006) PMID: 17054177 ↗
Interventions for treating collagenous colitis.
Clinical Trial Synthesis 2006 Randomized Controlled Trial (RCT) published in The Cochrane database of systematic reviews involving n = 94 participants; statistical significance reported at p = 0.003. Key conclusion: Those randomized to active drug were more likely to have clinical (p = 0.003) and histological (p = 0.003) improvement than those assigned to placebo.
View Original PubMed Abstract ↓

BACKGROUND: Collagenous colitis is a disorder that is recognized as a cause of chronic diarrhea. Treatment has been based mainly on anecdotal evidence. This review was performed to identify therapies for collagenous colitis that have been proven in randomized trials. OBJECTIVES: To determine effective treatments for patients with clinically active collagenous colitis. SEARCH STRATEGY: Relevant papers published between 1970 and June 2006 were identified via the MEDLINE and PUBMED databases. Manual searches from the references of identified papers, as well as review papers on collagenous or microscopic colitis were performed to identify additional studies. Abstracts from major gastroenterological meetings were searched to identify research submitted in abstract form only. Finally, the Cochrane Controlled Trials Register and the Cochrane Inflammatory Bowel Disease and Functional Bowel Disorders Group Specialized Trials Register were searched for other studies. SELECTION CRITERIA: Seven randomized trials were identified. One trial studied bismuth subsalicylate (published in abstract form only), one trial studied Boswellia serrata extract (published in abstract form only), one trial studied probiotics, one trial studied prednisolone, and 3 trials studied budesonide for the therapy of collagenous colitis. DATA COLLECTION AND ANALYSIS: Data were extracted independently by each author onto 2x2 tables (treatment versus placebo and response versus no response). For therapies assessed in one trial only, p-values were derived using the chi-square test. For therapies assessed in more than one trial, summary test statistics were derived using the Peto odds ratio and 95% confidence intervals. Data were combined for analysis only if the outcomes were sufficiently similar in definition. MAIN RESULTS: There were 9 patients with collagenous colitis in the trial studying bismuth subsalicylate (nine 262 mg tablets daily for 8 weeks). Those randomized to active drug were more likely to have clinical (p = 0.003) and histological (p = 0.003) improvement than those assigned to placebo. Eleven patients were enrolled in the trial studying prednisolone (50 mg daily for 2 weeks). There was

05
RANDOMIZED TRIAL (RCT) Pharmaceutical research (2025) PMID: 39875757 ↗
Efficacy and Safety of Boswellia serrata and Apium graveolens L. Extract Against Knee Osteoarthritis and Cartilage Degeneration: A Randomized, Double-blind, Multicenter, Placebo-Controlled Clinical Trial.
Clinical Trial Synthesis 2025 Randomized Controlled Trial (RCT) published in Pharmaceutical research involving n = 62 participants. Key conclusion: CONCLUSIONS: Taken together, the combination of Boswellia and celery could be a safe and promising herbal nutraceutical option for managing osteoarthritis and cartilage health effectively.
View Original PubMed Abstract ↓

BACKGROUND: 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. METHODS: 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. RESULTS: 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. CONCLUSIONS: Taken together, the combination of Boswellia and celery could be a safe and promising herbal nutraceutical option for managing osteoarthritis and cartilage health effectively. © 2025. The Author(s).

06
RANDOMIZED TRIAL (RCT) Explore (New York, N.Y.) (2025) PMID: 39700654 ↗
Efficacy and safety evaluation of Boswellia serrata and Curcuma longa extract combination in the management of chronic lower back pain: A randomised, double-blind, placebo-controlled clinical study.
Clinical Trial Synthesis 2025 Randomized Controlled Trial (RCT) published in Explore (New York, N.Y.) involving n = 45 participants; statistical significance reported at p = 0.001. Key conclusion: This outcome was consistent with a decrease in serum inflammatory markers and improved therapy assessment scores.
View Original PubMed Abstract ↓

BACKGROUND AND AIM: 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. MATERIAL AND METHODS: 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. RESULTS: 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. CONCLUSION: 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.

07
RANDOMIZED TRIAL (RCT) Journal of the American Nutrition Association (2025) PMID: 39700461 ↗
A Standardized Boswellia serrata Extract Improves Knee Joint Function and Cartilage Morphology in Human Volunteers with Mild to Moderate Osteoarthritis in a Randomized Placebo-Controlled Study.
Clinical Trial Synthesis 2025 Randomized Controlled Trial (RCT) published in Journal of the American Nutrition Association; statistical significance reported at p = 0.001. Key conclusion: CONCLUSION: SN13108F supplementation is safe, and it mitigates joint pain and improves musculoskeletal function and cartilage morphology in KOA.
View Original PubMed Abstract ↓

BACKGROUND AND OBJECTIVE: 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). MATERIALS AND METHODS: 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. RESULTS: 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. CONCLUSION: SN13108F supplementation is safe, and it mitigates joint pain and improves musculoskeletal function and cartilage morphology in KOA.

08
RANDOMIZED TRIAL (RCT) Journal of medicinal food (2024) PMID: 39446666 ↗
Investigating the Additive Effects of Loxacon(®) Food Supplement Capsules in Patients with Knee Osteoarthritis. A Multicenter, Randomized, Double-Blind, Controlled, Crossover, Follow-Up, Three-Arm Study.
Clinical Trial Synthesis 2024 Randomized Controlled Trial (RCT) published in Journal of medicinal food involving n = 88 participants. Key conclusion: 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.
View Original PubMed Abstract ↓

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.

09
RANDOMIZED TRIAL (RCT) Biological & pharmaceutical bulletin (2024) PMID: 39343544 ↗
Pharmacokinetics of a Natural Self-emulsifying Reversible Hybrid-Hydrogel (N'SERH) Formulation of Full-Spectrum Boswellia serrata Oleo-Gum Resin Extract: Randomised Double-Blinded Placebo-Controlled Crossover Study.
Clinical Trial Synthesis 2024 Randomized Controlled Trial (RCT) published in Biological & pharmaceutical bulletin involving n = 16 participants; statistical significance reported at p = 0.001. Key conclusion: In summary, the natural self-emulsifying reversible hybrid-hydrogel (N'SERH) formulation of boswellia extract using fenugreek mucilage (FenuMat®) significantly increased the solubility (58-fold), stability, and bioavailability of both the volatile and non-volatile bioactives whic
View Original PubMed Abstract ↓

The oleo-gum-resin of Boswellia serrata, an Ayurvedic herb for the treatment of chronic inflammatory diseases, contains both volatile (terpenes) and nonvolatile (boswellic acids) molecules as responsible for its bioactivity. The present randomized, double-blinded, placebo-controlled, crossover study evaluated the human pharmacokinetics of a 'natural' hybrid-hydrogel formulation of a unique full-spectrum boswellia extract (BFQ-20) (standardized for both volatile and nonvolatile bioactives) in comparison with unformulated extract (U-BE), for the first time. Mass spectrometry coupled with LC (UPLC-MS/MS) and gas chromatography (GC-MS/MS) measurements of the plasma concentration of boswellic acids and α-thujene at different post-administration time points followed by a single dose (400 mg) of U-BE and BFQ-20, to healthy volunteers (n = 16), offered 4-fold enhancement in the overall bioavailability of boswellic acids from BFQ-20, [area under the curve (AUC) (BFQ-20) = 9484.17 ± 767.82 ng * h/mL vs. AUC (U-BE) = 2365.87 ± 346.89 ng * h/mL], with the absorption maximum (Tmax) at 6.3 h post-administration and elimination half-life (T1/2) of 15.5 h (p < 0.001). While plasma α-thujene was not detectable upon U-BE administration, BFQ-20 provided significant absorption, [AUC (BFQ-20): 298.60 ± 35.48 ng * h/mL; Cmax: 68.80 ± 18.60 ng/mL; Tmax: 4.12 ± 0.38 h; T1/2: 16.24 ± 1.12 h]. Further investigation of the anti-inflammatory effect revealed 70.5% inhibition of paw edema in rats compared to 38.0% for U-BE. In summary, the natural self-emulsifying reversible hybrid-hydrogel (N'SERH) formulation of boswellia extract using fenugreek mucilage (FenuMat®) significantly increased the solubility (58-fold), stability, and bioavailability of both the volatile and non-volatile bioactives which in turn improved the anti-inflammatory efficacy of Boswellia extract.

10
CLINICAL STUDY Journal of complementary & integrative medicine (2024) PMID: 38958698 ↗
The role of nutraceuticals in the management of temporomandibular disorders.
Clinical Trial Synthesis 2024 Clinical Study published in Journal of complementary & integrative medicine; statistical significance reported at p = 0.05. Key conclusion: CONCLUSIONS: 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.
View Original PubMed Abstract ↓

OBJECTIVES: 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. METHODS: 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. RESULTS: The groups using nutraceuticals showed statistically significant improvements over controls for most of the variables analyzed. CONCLUSIONS: 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. © 2024 the author(s), published by De Gruyter, Berlin/Boston.

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