Effect of Boswellia Serrata on Pain Intensity, Central and Peripheral Sensitization, and Pain Modulation in Healthy Volunteers
RecruitingNot applicableNCT07109843
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This study has no listed site in Canada in this snapshot. It is included as part of the worldwide chronic pain corpus.
Brief summary (from the registry)
This planned study is based on a randomized, placebo-controlled cross-over design. Boswellic acids, the triterpenes found in the gum resins of Boswellia serrata (family: Burseraceae), are traditionally used in the Indian Ayurvedic medicine system as antioxidants and anti-inflammatory agents for treating conditions such as rheumatoid arthritis, chronic bronchitis, asthma, and chronic inflammatory bowel diseases (ulcerative colitis and Crohn's disease). The β-configured pentacyclic triterpenic acids in B. serrata include 3-acetyl-11-keto-β-boswellic acid (AKBBA), 11-keto-β-boswellic acid (KBBA), β-boswellic acid (BBA), and 3-acetyl-β-boswellic acid (ABBA). These compounds, which constitute approximately 14% of the lipophilic fractions of the B. serrata extract, are the major active components. Boswellia serrata is marketed as a food supplement in accordance with EU Directive 2002/46/EC. Several clinical studies have examined the efficacy of B. serrata in chronic pain conditions. The data suggest a clinical analgesic efficacy, without, however, allowing conclusions about the underlying mechanisms. These have not yet been investigated in a human experimental pain model. The aim of the study is to investigate the influence of Boswellia serrata in peripheral and central sensitization, as well as descending inhibitory pathways by Quantitative Sensory Testing (QST). These findings are of great relevance for a better understanding of clinical efficacy. The 'Capsaicin Pain Model' is a validated method for inducing short-term peripheral and central sensitization. As a non-invasive human pain model, it is therefore well suited for investigating the analgesic and anti-hyperalgesic effects of drugs. Furthermore, the influence of Boswellia serrata on mood (depression, anxiety), sleep quality and psychological well-being will be investigated by using the psychological questionnaires Becks-Depression-Inventory, Becks-Anxiety-Inventory, Pittsburgh Sleep Quality Index and World Health…
Study details
- Official title
- Effect of Boswellia Serrata on Pain Intensity, Central and Peripheral Sensitization, and Pain Modulation in Healthy Volunteers - a Randomized, Double-blind, Placebo-controlled, Cross-over Pilot Trial
- Conditions
- Chronic Pain
- Central Sensitisation
- Peripheral Sensitization
- Neuroinflammatory Response
- Interventions
- Dietary supplement: Boswellia serrata extract
- Other: Placebo
- Sponsor
- Medical University of Graz
- Start date
- 2025-09-01
- Primary completion
- 2025-12-31
- Sex
- All
- Age range
- from 18 Years
- Healthy volunteers
- true
- Results posted
- No results posted in this snapshot
- Countries
- Austria
- Total sites listed
- 1
Eligibility criteria
Show eligibility criteria (verbatim from the registry)
Inclusion Criteria: * Age: ≥18 years Exclusion Criteria: * Not pregnant or breastfeeding * No renal or liver insufficiency * No neurological/dermatological/cardiovascular diseases * No chronic pain and/or use of analgesics * No use of anticoagulants * No use of antidepressants * No use of MAO inhibitors * No use of St. John's Wort * No use of medications affecting the CYP mechanism * No allergies to Boswellia serrata or capsaicin"
Source: ClinicalTrials.gov (US National Library of Medicine), snapshot October 2026. Check the registry for current recruiting status. Record: https://clinicaltrials.gov/study/NCT07109843