Effects of Standardized Boswellia Carterii Extract on Irritable Bowel Syndrome Patients

NCT07576634 | Completed Phase 2 DMC

• 1 other identifier: Boswellia on IBS patients
• Study Type: interventional
• Target: 60
• Locations: 1 country
• Sites: 1

Brief Summary

Irritable bowel syndrome (IBS) is a common condition that affects the stomach and intestines. It can cause abdominal pain, bloating, diarrhea, constipation, and changes in bowel habits, which may reduce a person's quality of life. Many people with IBS do not achieve complete symptom relief with standard treatments. The purpose of this study is to evaluate whether a standardized Boswellia extract, combined with structured patient education, can help improve IBS symptoms and quality of life. Boswellia is a herbal extract that may help reduce inflammation and digestive discomfort. In this study, 60 adults aged 18-39 years with moderate IBS were enrolled at Mansoura University Hospitals, Egypt. Participants received 500 mg of standardized Boswellia extract twice daily for 30 days and attended educational sessions about IBS self-management, including symptom control and healthy lifestyle practices. Researchers evaluated abdominal pain, bloating, bowel habits, other gastrointestinal symptoms, and quality of life at the start of the study, after one week, and after one month to determine whether the intervention improved IBS symptoms and daily functioning.

Conditions

Irritable Bowel Syndrome

Keywords

Boswellia extract Complementary therapy Gut-brain axis Quality of life

Outcome Measures

Primary Outcomes (1)

• This study aims to assess effects of standardized Boswellia extract on irritable bowel syndrome patients

  H1: Patients with irritable bowel syndrome (IBS) who take standardized boswellia extract will experience a reduction in abdominal bloating. H1: Patients with IBS who take standardized boswellia extract will experience a reduction in abdominal pain. H1: Patients with IBS who take standardized boswellia extract will improve their quality of life. Abdominal pain was assessed using a structured questionnaire. Pain location was coded as a categorical variable (1-4), pain quality as a categorical variable (1-4), and pain pattern as a categorical variable (1-2). Pain triggers were recorded as an open numeric variable. Pain intensity was measured using a numerical rating scale ranging from 0 (no pain) to 10 (worst possible pain. Pain intensity was measured using a numerical rating scale (0-10), and additional details such as pain location, quality, and pattern were documented. quality of life assessment structured questionnaire The researcher used this tool to assess work absenteeism,

  The study hypotheses was conducted at three time points: before the initiation of the intervention (baseline), one week after the intervention, and one month following the intervention.

Study Arms (1)

Participants received 500 mg standardized Boswellia extract (≥65% boswellic acids) twice daily

EXPERIMENTAL

Phytochemical standardization of the Boswellia carterii oleogum resin extract was conducted at the FAB-Lab (Faculty of Pharmacy, Mansoura University) to ensure batch-to-batch consistency and defined bioactive content. The extract was standardized to contain ≥65% total boswellic acids, based on previously established analytical and isolation methodologies developed in our laboratory. These procedures include chromatographic separation and characterization of immunomodulatory triterpenoids(7), as well as validation of leukotriene-inhibitory activity and bioactive compound profiling, as described in earlier pharmacological and clinical investigations of Boswellia preparations(8). The standardization approach has been consistently applied in prior experimental and clinical studies evaluating anti-inflammatory, immunomodulatory, antiviral, and osteoarthritis-related therapeutic effects of Boswellia-derived compounds, thereby ensuring reproducibility, phytochemical integrity, and biological

Drug: Boswellia carterii Extract; Other: Educationntal program for IBS patie

Interventions

Boswellia carterii Extract DRUG

A soft gelatin capsule containing 500 mg of standardized Boswellia extract (containing more than 65% Boswellia acids) was administered orally twice daily with meals for a duration of 30 days. The researcher met with the participants five times per week at the outpatient clinics of Mansoura University Hospitals. During these meetings, participants were instructed on the proper administration of the capsules and were informed about potential side effects, including headache, diarrhea, renal complications, weight gain, osteoporosis, increased risk of infection, and high cost. In addition, the researcher conducted weekly follow-up phone calls, particularly during the first week of treatment, to assess the occurrence of any allergic reactions or adverse effects related to the Boswellia capsules. These follow-ups also aim to monitor adherence to the intervention, identify any missed doses, and obtain feedback regarding participants perceived improvement.

Participants received 500 mg standardized Boswellia extract (≥65% boswellic acids) twice daily

Educationntal program for IBS patie OTHER

The researchers analyzed the findings from the assessment phase to identify gaps in knowledge and areas requiring improvement. Based on this analysis, the program's objectives and content were designed to address the specific educational needs of the IBS patients. All potential participants underwent an initial assessment to ensure that they met the inclusion criteria and did not meet any of the exclusion criteria. Demographic characteristics and relevant health-related data were collected from participants on the first day of the study using data collection tools as mentioned above. Educational sessions were provided to participants regarding irritable bowel syndrome (IBS) and the importance of Boswellia in the management of IBS

Participants received 500 mg standardized Boswellia extract (≥65% boswellic acids) twice daily

Eligibility Criteria

• Age: 18 Years - 65 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Adults diagnosed with irritable bowel syndrome (IBS) according to Rome III and Rome IV criteria Recurrent abdominal pain occurring at least once weekly during the preceding three months Presence of changes in stool frequency, stool form, or defecation associated with abdominal pain Participants reporting bloating as the primary symptom

You may not qualify if:

• Adherence to special diets (low-fat, lactose-free, or gluten-free diets) within the past six months Food allergies such as soy, nuts, or seafood allergies Insulin-dependent diabetes mellitus Celiac disease Inflammatory bowel disease History of major gastrointestinal surgery, including colonic surgery or cholecystectomy Bloody diarrhea, hematochezia, or melena Recent antibiotic use Presence of alarming gastrointestinal symptoms Severe renal disease Severe hepatic disease Pregnancy Breastfeeding

Sponsors & Collaborators

• Mansoura University: lead

Study Sites (1)

Mansoura University

Al Mansurah, Egypt

Location

MeSH Terms

Conditions

Irritable Bowel Syndrome

Condition Hierarchy (Ancestors)

Colonic Diseases, Functional; Colonic Diseases; Intestinal Diseases; Gastrointestinal Diseases; Digestive System Diseases

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: NON RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: In this quasi-experimental study, 60 adults (18-39 years) with moderate IBS were enrolled at Mansoura University Hospitals, Egypt. Participants received 500 mg standardized Boswellia extract (≥65% boswellic acids) twice daily for 30 days.In addition, Boswellia-derived compounds have been demonstrated to inhibit leukotriene synthesis through suppression of 5-lipoxygenase activity, a key inflammatory pathway implicated in immune activation and tissue inflammation. Natural leukotriene inhibitors isolated from Boswellia have shown potent anti-inflammatory effects, supporting their relevance in inflammatory disorders. Given the emerging role of leukotriene-mediated low-grade inflammation in IBS pathophysiology, this mechanism offers further biological plausibility for symptom improvement associated with Boswellia supplementation

Study Record Dates

• First Submitted: April 3, 2026
• First Posted: May 8, 2026
• Study Start: January 1, 2025
• Primary Completion: December 30, 2025
• Study Completion: January 30, 2026
• Last Updated: May 8, 2026

Record last verified: 2026-04

Locations

EG (1)