Integral yoga intervention for managing constipation predominant irritable bowel syndrome: a randomized controlled trial
试验速览
- 阶段
- 2/3 期
- 状态
- 尚未招募
- 入组人数
- 120
- 试验地点
- 1
- 主要终点
- Change in IBS Symptom Severity Score (IBS-SSS)
研究概览
简要总结
Slow moving stool in the intestine often becomes dehydrated creating hard stool, which can exacerbate symptoms of constipation and this type of constipation predominant is the most common type, affecting nearly 50% of people with IBS. Stool transit time may be sped up or slowed down due to a disruption in communication between the brain and the intestine. Assuming that the syndrome may have general autonomic control as the main player in etiopathogenesis, we considered studying the efficacy of integral yoga interventions on symptoms severity, gastrointestinal health, quality of life, visceral sensitivity, gastrointestinal cognition and fear of food like parameters in constipation predominant IBS patients. It will provide insights into the benefits for integrating yoga intervention for other diseases too to foster holistic health in patients. The finding could inform both educational practices and health policies aimed at enhancing overall health of the people.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 盲法
- Outcome Assessor Blinded
入排标准
- 年龄范围
- 18.00 Year(s) 至 59.00 Year(s)(—)
- 性别
- All
入选标准
- •Patient diagnosed with IBS-C, based on ROME-IV criteria.
- •Not enrolled in any other alternatives medicine programs.
- •Committed for 3 Months interventions and follow up procedures.
排除标准
- •Patients with other medical issues like DM, HTN, Thyroid, kidney, heart and liver diseases, etc.
- •Severe psychiatric disorders, physical and mental disability to do yoga.
- •Patient’s history of drug, alcohol, or chemical abuse within 6 months prior to screening.
- •Inability to comply with study and follow up procedures.
- •Pregnant and lactating women.
结局指标
主要结局
Change in IBS Symptom Severity Score (IBS-SSS)
时间窗: At baseline (T0) and at 3 months (T1)
次要结局
- Changes in quality of life (IBS-QOL), gastrointestinal cognition and health, fear of food and visceral sensitivity of IBS-C Patients.(At baseline (T0) and at 3 months (T1))
研究者
Dr Rudra Bhandari
University of Patanjali
