To Compare the Efficacy of (Rifaximin + Mebeverine), (Rifaximin + Amitriptyline), and (Rifaximin + Psyllium Husk) in Irritable Bowel Syndrome Associated With Diarrhea
试验速览
- 阶段
- 4 期
- 状态
- 已完成
- 入组人数
- 162
- 试验地点
- 1
- 主要终点
- Compare Efficacy of Treatment Regimes in Treatment Groups
研究概览
简要总结
The goal of this clinical trial is to compare the efficacy of four different drugs in combination for management of irritable bowel syndrome (IBS)-associated diarrhea. The main question to answer is:
- Is there a significant difference in effect of different drug combinations in management of irritable bowel syndrome with diarrhea?
Participants will be divided into 3 treatment groups.
- Each group will be given a combination of drugs for 2 weeks
- At the end of study, efficacy of different drug combinations and their potential side effects will be compared between the treatment groups
详细描述
The goal of this clinical trial is to compare the efficacy of four different drugs (Rifaximin , Mebeverine, Amitriptyline and Psyllium Husk) in combination for management of irritable bowel syndrome (IBS)-associated diarrhea. The main question to answer is:
• Is there a significant difference in effect of different drug combinations in management of irritable bowel syndrome with diarrhea?
Total of 162 Participants will be enrolled in study.
- Participants will be divided into 3 treatment groups i.e. Group A, Group B and Group C.
- Participants of Group A will receive drug combination of Rifaximin and Mebeverine
- Participants of Group B will receive drug combination of Rifaximin and Amitriptyline
- Participants of Group C will receive drug combination of Rifaximin and Psyllium Husk
- Each group will be given a combination of drugs for 2 weeks
Stool Frequency, Characteristic of Stool and Abdominal Pain will be assessed at day 0 and day 14 of intervention
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 45 Years(Adult)
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Individual of both gender between the age of 18-50 years Diagnosed case of Irritable Bowel Syndrome associated with Diarrhea
排除标准
- •Presence of co morbid diseases
- •Coronary Artery Disease (CAD)
- •Chronic Obstructive Pulmonary Disease (COPD)
- •Congestive Heart Failure (CHF)
- •Patients taking drugs which modify or aggravate symptoms of IBS (antidepressants, calcium channel blockers etc.)
- •Patients having hyperthyroidism & gluten hypersensitivity
- •Patients with alarming symptoms, viz. history of fever, passage of blood in stool, loss of weight, any organic gastrointestinal disease in the recent past
- •Patients with recent change in bowel habits, patients on any other concomitant medication for abdominal pain, bowel disturbance or altering gastrointestinal motility and malignancy of any other organ
- •Patients with Irritable Bowel Disease and Celiac disease
研究组 & 干预措施
Group C ( Rifaximin + Psyllium Husk )
Tab. Rifaximin 550mg thrice daily per orally for 2 weeks
Psyllium Husk 15-30mg once daily per orally for 2 weeks
干预措施: Rifaximin 550 MG (Drug)
Group A ( Rifaximin + Mebeverine )
Tab. Rifaximin 550mg thrice daily per orally for 2 weeks
Tab. Mebeverine 135mg twice daily per orally for 2 weeks
干预措施: Rifaximin 550 MG (Drug)
Group A ( Rifaximin + Mebeverine )
Tab. Rifaximin 550mg thrice daily per orally for 2 weeks
Tab. Mebeverine 135mg twice daily per orally for 2 weeks
干预措施: Mebeverine 135 MG (Drug)
Group B ( Rifaximin + Amitriptyline )
Tab. Rifaximin 550mg thrice daily per orally for 2 weeks
Tab. Amitriptyline 25mg once daily per orally for 2 weeks
干预措施: Rifaximin 550 MG (Drug)
Group B ( Rifaximin + Amitriptyline )
Tab. Rifaximin 550mg thrice daily per orally for 2 weeks
Tab. Amitriptyline 25mg once daily per orally for 2 weeks
干预措施: Amitriptyline Hydrochloride 25 MG (Drug)
Group C ( Rifaximin + Psyllium Husk )
Tab. Rifaximin 550mg thrice daily per orally for 2 weeks
Psyllium Husk 15-30mg once daily per orally for 2 weeks
干预措施: Psyllium Husk (Drug)
结局指标
主要结局
Compare Efficacy of Treatment Regimes in Treatment Groups
时间窗: 4 Weeks
The study will assess and compare the effect of each treatment regime on reduction of diarrhea, improvement in abdominal pain among the treatment groups
Overall Improvement in Characteristic of Diarrhea
时间窗: 2 Weeks
The study will assess change in characteristic of stool type from type 6,7 to 4 according to Bristol Stool Chart from day 0 to day 14
Overall Improvement in Abdominal Pain
时间窗: 2 Weeks
The study will assess change in abdominal pain from day 0 to day 14
Overall Improvement in Frequency of Diarrhea
时间窗: 2 Weeks
The study will assess change in number of stools per day from day 0 to day 14
次要结局
- To observe adverse effects of treatment regimes(2 Weeks)
研究者
Rashid Ali Khosa
Lecturer
Bahria University
