An Open-Label, Single-Arm, Single-Centre Clinical Study to Evaluate the Safety and Efficacy of Triphala Capsules in Participants with Constipation Predominant Irritable Bowel Syndrome.
试验速览
- 阶段
- 3 期
- 状态
- 尚未招募
- 发起方
- 入组人数
- 35
- 试验地点
- 1
研究概览
简要总结
Introduction
Irritable Bowel Syndrome with constipation predominance is a chronic functional gastrointestinal disorder characterized by abdominal discomfort, altered bowel habits, infrequent bowel movements, bloating, and impaired quality of life. Conventional management options often provide inconsistent or temporary relief and may be associated with adverse effects, leading to increasing interest in complementary therapies. Triphala, a traditional Ayurvedic polyherbal formulation, has been widely used to support digestive health and bowel regularity and is known for its mild laxative, gut-modulating, and anti-inflammatory properties, suggesting potential benefit in constipation-predominant Irritable Bowel Syndrome.
Purpose of the Study
The purpose of this study is to evaluate the safety and efficacy of Triphala capsules administered once daily in adult participants diagnosed with constipation-predominant Irritable Bowel Syndrome. The study aims to assess improvement in symptom severity, stool frequency, and quality of life over a 30-day treatment period, along with monitoring tolerability and safety. The results of this study are expected to generate clinical evidence on the therapeutic potential of Triphala in the management of IBS-C.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 盲法
- None
入排标准
- 年龄范围
- 18.00 Day(s) 至 65.00 Day(s)（—）
- 性别
- All
入选标准
- •Participants of either sex with age between 18 years and 65 years.
- •Diagnosis of IBS as per Rome IV criteria with following symptoms for more than 3 months.
- •Abdominal discomfort such as mild pain, cramping, bloating Altered bowel habit indicated by frequent constipation Functional dyspepsia
- •Able and willing to give written informed consent.
- •Women of childbearing potential must be willing to practice an acceptable method of contraception throughout the study.
- •Willingness and ability to comply with all study procedures, visit schedules, and follow-up assessments.
排除标准
- •Pregnant, breastfeeding, or planning pregnancy during the study.
- •Uncontrolled diabetes, hypertension, symptomatic congestive heart failure, unstable angina pectoris, myocardial infarction.
- •On antibiotics or laxatives within the preceding 6 weeks.
- •Presence of inflammatory bowel disease, acute GI tract infection.
- •Presence of fever, abdominal mass, signs of bowel obstruction.
- •History of colon cancer or diverticulitis.
- •Participated in another clinical drug trial within 3 months before recruitment.
- •Currently active alcohol or drug abuse or history of alcohol or drug abuse within 24 weeks prior to Baseline.
研究者
Dr Manjunath U
Currex Hospital Bangalore