A Pilot Quasi-experimental Study Evaluating a Standardized Boswellia Carterii Extract Combined With Structured Patient Education in IBS
试验速览
- 阶段
- 2 期
- 状态
- 已完成
- 入组人数
- 60
- 试验地点
- 1
研究概览
简要总结
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.
详细描述
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.
研究设计
- 研究类型
- Interventional
- 分配方式
- Non Randomized
- 干预模型
- Single Group
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 65 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •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
排除标准
- •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