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

What this Trial Is About

Researchers are studying Boswellia serrata, a traditional herbal extract used for its antioxidant and anti-inflammatory properties in conditions like rheumatoid arthritis and chronic inflammatory diseases. This randomized, double-blind, placebo-controlled crossover trial aims to understand how Boswellia serrata affects pain intensity, peripheral and central sensitization, and pain modulation using a validated human pain model called the Capsaicin Pain Model. The study also evaluates its impact on mood, sleep quality, and psychological well-being through questionnaires. Participants receive either 600 mg of Boswellia serrata extract or a placebo daily for 28 days in two treatment phases separated by a 4-week washout. The Capsaicin Pain Model involves applying capsaicin patches to the skin to induce localized pain and sensitization, allowing researchers to measure changes in pain perception and modulation. Both treatments are given in capsule form, and adherence is supported by electronic reminders. During the study, participants undergo multiple assessments including pain intensity ratings, sensitivity to mechanical and heat stimuli, and conditioned pain modulation tests. Psychological evaluations for depression, anxiety, sleep quality, and well-being are conducted using standardized questionnaires at several time points. Safety is monitored through adverse effect documentation, and the total participation spans over several visits across the treatment and washout periods.

Effect of Boswellia Serrata on Pain Intensity, Central and Peripheral Sensitization, and Pain Modulation in Healthy Volunteers