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

NCT07109843 | Recruiting

• 2 other identifiers: BS2025PPMedical University of Graz
• Study Type: interventional
• Target: 12
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

Chronic Pain; Central Sensitisation; Peripheral Sensitization; Neuroinflammatory Response

Outcome Measures

Primary Outcomes (1)

• Change in spontaneous pain intensity

  is measured on a visual analogue scale (0 means no pain and 10 means the worst imaginable pain)

  Day 0 -->Day 28 before capsaicin pain model --> Day 28 1 hour after capsaicin pain model --> Day 56 -->Day 84 before capsaicin pain model -->Day 84 1 hour after capsaicin pain model

Secondary Outcomes (9)

• Change in Allodynia

  Day 0 -->Day 28 before capsaicin pain model --> Day 28 1 hour after capsaicin pain model --> Day 56 -->Day 84 before capsaicin pain model -->Day 84 1 hour after capsaicin pain model

• Change in Hyperalgesia

  Day 0 -->Day 28 before capsaicin pain model --> Day 28 1 hour after capsaicin pain model --> Day 56 -->Day 84 before capsaicin pain model -->Day 84 1 hour after capsaicin pain model

• Change in heat detection threshold

  Day 0 -->Day 28 before capsaicin pain model --> Day 28 1 hour after capsaicin pain model --> Day 56 -->Day 84 before capsaicin pain model -->Day 84 1 hour after capsaicin pain model

• Change in heat pain threshold

  Day 0 -->Day 28 before capsaicin pain model --> Day 28 1 hour after capsaicin pain model --> Day 56 -->Day 84 before capsaicin pain model -->Day 84 1 hour after capsaicin pain model

• Change in conditioned pain modulation

  Day 0 -->Day 28 before capsaicin pain model --> Day 28 1 hour after capsaicin pain model --> Day 56 -->Day 84 before capsaicin pain model -->Day 84 1 hour after capsaicin pain model

Study Arms (2)

Verum (Boswellia Serrata)

EXPERIMENTAL

One capsule 600mg per day for 28 days

Dietary Supplement: Boswellia serrata extract; Other: Placebo

Placebo

PLACEBO COMPARATOR

1 capsule placebo per day for 28 days

Dietary Supplement: Boswellia serrata extract; Other: Placebo

Interventions

Boswellia serrata extract DIETARY_SUPPLEMENT

Boswellia Serrata 1x day (600mg)

Also known as: Boswellia

Placebo; Verum (Boswellia Serrata)

Placebo OTHER

Placebo 1x/day

Placebo; Verum (Boswellia Serrata)

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Age: ≥18 years

You may not qualify if:

• 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"

Sponsors & Collaborators

• Medical University of Graz: lead

Study Sites (1)

Medical University of Graz

Graz, Styria, 8010, Austria

RECRUITING

MeSH Terms

Conditions

Chronic Pain

Interventions

Frankincense

Condition Hierarchy (Ancestors)

Pain; Neurologic Manifestations; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Resins, Plant; Biopolymers; Polymers; Macromolecular Substances; Plant Exudates; Biological Products; Complex Mixtures

Central Study Contacts

Helmar Bornemann-Cimenti, PD Dr. MD MSc MBA

CONTACT

+43 316 385 81103; helmar.bornemann@medunigraz.at

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: BASIC SCIENCE
• Intervention Model: CROSSOVER
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: Randomized, double-blind, placebo-controlled, cross-over design.

Study Record Dates

• First Submitted: July 31, 2025
• First Posted: August 7, 2025
• Study Start: September 1, 2025
• Primary Completion: December 31, 2025
• Study Completion: December 31, 2025
• Last Updated: September 24, 2025

Record last verified: 2025-08

Data Sharing

• IPD Sharing: Will not share

Locations

AU (1)