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Completed

NCT Number: NCT07576634

Effects of Standardized Boswellia Carterii Extract on Irritable Bowel Syndrome Patients

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.

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Key information

Age range

18 year–65 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 2 / Phase 3

Primary location

Mansoura University

Al Mansurah, Egypt

About this study

Irritable bowel syndrome (IBS) is a common and often debilitating gastrointestinal disorder characterized by recurrent abdominal pain, bloating, and altered bowel habits without identifiable structural pathology. Diagnosis relies primarily on symptom-based criteria and the exclusion of other conditions, with IBS defined as abdominal discomfort or pain associated with changes in bowel habits for at least three months. IBS is among the most frequently encountered gastrointestinal conditions in both primary and secondary care. Advances in research and updates from the British Society of Gastroenterology have re-framed IBS as a disorder of gut-brain interaction (DGBI) rather than a purely functional disorder, with over 40% of individuals worldwide estimated to meet diagnostic criteria for at least one DGBI during their lifetime. [1,2,4].Study Design and Setting

This quasi-experimental study was conducted to assess the effects of standardized Boswellia Cartteri extract on abdominal bloating, abdominal pain, and quality of life in patients with irritable bowel syndrome (IBS). The study took place at the outpatient clinics of Mansoura University Hospitals.

Participant and Sampling

Inclusion criteria

Adult patients with moderate IBS were recruited through convenience sampling. Eligible participants were aged 18-39 years, literate, and reported bloating as their primary symptom. IBS diagnosis was confirmed according to Rome III and IV criteria, which require recurrent abdominal pain at least once weekly over the preceding three months, accompanied by changes in stool frequency, form, or defecation.

Exclusion criteria

included adherence to special diets (low-fat, lactose-free, gluten-free) within the past six months, food allergies (e.g., soy, nuts, seafood), insulin-dependent diabetes, celiac disease, inflammatory bowel disease, prior major gastrointestinal surgery(colonic surgery, or cholecystectomy), Bloody diarrhea, hematochezia or melanic stools, recent antibiotic use, alarming gastrointestinal symptoms, severe renal or hepatic disease, pregnancy, and breastfeeding.

Sample Size A minimum of 60 participants was determined using G*Power software, accounting for a 30% dropout rate. The calculation assumed a significance level of 0.05, 95% statistical power, and a large effect size (0.8), based on prior studies examining the effects of Boswellia Cartter on abdominal bloating.( Kazemian, Yuan, Cochran, & Khoshnevis, 2017).

Data Collection Instruments

Four validated instruments were employed for data collection:

  • Sociodemographic and Lifestyle Questionnaire A structured, self-administered questionnaire was used to collect information on participants' age, gender, education, marital status, occupation, smoking habits, income, sleep adequacy, and other relevant lifestyle factors.
  • Gastrointestinal Symptom Assessment (Rome III & IV) Gastrointestinal symptoms were evaluated using an adapted Rome-based questionnaire, which assessed abdominal pain, bloating, stool frequency and form, bowel habit sub-type, and symptom relief following defecation. Responses were recorded as categorical or dichotomous variables. ( Lacy and Patel 2017) and Goodoory, V. C., Houghton, L. A., Yiannakou, Y., Black, C. J., & Ford, A. C. 2022).

Tool III: Abdominal bloatingand pain score questionnaire:

The researcher used this tool to assess patients' experience of bloating/uncomfortably full on a scale of none (no symptom), mild (does not interfere with activities), moderate (somewhat interferes with activities), and severe (renders usual activities impossible). The researcher adapted the tool from Lacy, Cangemi, Wise and Crowell (2021) The frequency of bloating was assessed by recording the number of days participants experienced bloating during the previous seven days, coded as an integer variable ranging from 0 to 7. Pain intensity was measured using a numerical rating scale (0-10), and additional details such as pain location, quality, and pattern were documented. It was measured using a numerical rating scale ranging from 0 (no pain) to 10 (worst possible pain) (Mujagic, et al.,2015; Karcioglu, Topacoglu, Dikme, & Dikme, 2018).

Tool V: quality of life assessment structured questionnaire The researcher used this tool to assess work absences, social life, sleep, and leisure activities, physical, psychological, and financial aspects. The researcher adapted the tool

Irritable bowel syndrome also imposes a substantial economic burden on healthcare systems worldwide, with significant direct and indirect costs reported across the United States, Europe, and Asia [1].

The pathophysiology of IBS is multi factorial, involving interactions among dietary factors, gut microbiota alterations, visceral hypersensitivity, immune dysregulation, and genetic predisposition. Contributions of these mechanisms may vary across populations due to cultural, geographic, and environmental differences. While IBS was historically considered functional, emerging evidence supports a biopsychosocial model emphasizing altered brain-gut communication, as reflected in the Rome IV diagnostic criteria. Recent studies highlight the role of low-grade inflammation and immune dysregulation in IBS pathogenesis. Bioactive triterpenoids from Boswellia carterii (frankincense) have been shown to regulate immune cell activity and inflammatory signaling pathways, including inhibition of 5-lipoxygenase and leukotriene synthesis, providing a biological rationale for their potential therapeutic effects in IBS. [5,6,7].

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 [8].

Bloating, affecting over 90% of IBS patients, is among the most distressing symptoms and significantly reduces quality of life, contributing to psychological distress, impaired productivity, and social embarrassment. Overall, IBS negatively impacts daily functioning, occupational performance, and social participation. Despite its prevalence, challenges in diagnosis and treatment often delay effective management, and conventional pharmacological therapies primarily provide symptom relief, sometimes with limited efficacy or adverse effects. Consequently, many patients turn to complementary approaches, including dietary modifications and herbal therapies. Multidisciplinary management, incorporating physicians, nurses, dietitians, and psychologists, alongside patient education and self-management interventions, has been shown to improve symptom control and quality of life. [5,9,10,11].

Given the chronic nature of IBS, the limitations of current treatments, and growing interest in complementary therapies, investigating the effects of standardized Boswellia extract offers a promising avenue for adjunctive management of IBS.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

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

Exclusion criteria

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

Treatment and study plan

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.

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

Primary outcomes

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

    Time frame: 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.

    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,

Sponsors and collaborators

Lead sponsor

Mansoura University

Other

Registry information

Official study title

A Pilot Quasi-experimental Study Evaluating a Standardized Boswellia Carterii Extract Combined With Structured Patient Education in IBS

Acronym: BC-IBS

Important dates

Study start
2025
Primary completion
2025
Study completion
2026
First posted
May 8, 2026
Registry last updated
May 8, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

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This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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