CTRI/2020/09/027773尚未招募2 期
EFFICACY OF WHOLE SYSTEM AYURVEDA PROTOCOL IN IRRITABLEBOWEL SYNDROME–A RANDOMIZED CONTROLLED CLINICAL TRIAL
试验速览
- 阶段
- 2 期
- 状态
- 尚未招募
- 入组人数
- 40
- 试验地点
- 1
- 主要终点
- 1.IBS Adequate Relief
研究概览
简要总结
The study to evaluate the efficacy of Whole System Ayurveda Protocol in the management of Irritable Bowel Syndrome which will be done in the period of 60 days .The study will be conducted at KAHERs Shri B.M.K Ayurveda Mahavidyalaya and Research Centre owned KLE Ayurveda Hospital Shahpur ,Belgavi ,Karnataka,India. The outcome is to prove the Efficacy of Whole System Ayurveda Protocol in better management of Irritable Bowel Syndrome.End Point is the controlled Irritable Bowel Syndrome .
研究设计
- 研究类型
- Interventional
- 分配方式
- Computer generated randomization
- 盲法
- Open Label
入排标准
- 年龄范围
- 20.00 Year(s) 至 60.00 Year(s)（—）
- 性别
- All
入选标准
- •1.Irrespective of religion , occupation ,economic status 2.Subjects fulfilling the Diagnostic criteria for IBS Rome IV.
排除标准
- •1.Inflammatory bowel disorder 2.Malabsorbtion syndrome 3.Intestinal Tuberculosis –colonic 4.CA colon 5.Constipation caused by a condition called Paralytic ileus 6.Patient with any drug or alcohol dependancy 7.Patient have had an allergic reaction to Mebeverine or any other medicines in the past.
- •8.Patient with any co-morbidities necessitating long term drug treatment ,Rhumatoid arthritis , Tuberculosis etc.
- •9.Pregnant and Lactating women.
结局指标
主要结局
1.IBS Adequate Relief
时间窗: baseline ,15th day ,30th day ,45th day, 60th day
2.IBS Symptoms Severity Scale
时间窗: baseline ,15th day ,30th day ,45th day, 60th day
次要结局
- AbdominalPain-VAS(0-10)(baseline ,15th day ,30th day,45th day, 60th day)
- IBS-quality of life(baseline ,15th day ,30th day ,45th day, 60th day)
- Stool Consistency-Bristol Stool Form(BSF)(baseline ,15th day ,30th day ,45th day, 60th day)
- IBS-related bowel urgency(baseline ,15th day ,30th day ,45th day, 60th day)
- IBS global improvement Scale(IBS-GIS)(baseline ,15th day ,30th day ,45th day, 60th day)
- Hamilton Anxiety Rating Scale(baseline ,15th day ,30th day ,45th day, 60th day)
- Hamilton Depression Rating Scale(baseline ,15th day ,30th day ,45th day, 60th day)
研究者
研究点 (1)
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