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

Status: Recruiting
Location: See location...
Intervention Type: Other, Dietary supplement
Study Type: Interventional
Study Phase: Not Applicable
SUMMARY

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 Organization Well-Being Index (BDI-II, BAI, PSQI and WHO5) as secondary target variables.

Eligibility
Participation Requirements
Sex: All
Minimum Age: 18
Healthy Volunteers: t
View:

• Age: ≥18 years

Locations
Other Locations
Austria
Medical University of Graz
RECRUITING
Graz
Contact Information
Primary
Helmar Bornemann-Cimenti, PD Dr. MD MSc MBA
helmar.bornemann@medunigraz.at
+43 316 385 81103
Time Frame
Start Date: 2025-09-01
Estimated Completion Date: 2025-12-31
Participants
Target number of participants: 12
Treatments
Experimental: Verum (Boswellia Serrata)
One capsule 600mg per day for 28 days
Placebo_comparator: Placebo
1 capsule placebo per day for 28 days
Sponsors
Leads: Medical University of Graz

This content was sourced from clinicaltrials.gov