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临床试验/NCT05867550
NCT05867550已完成4 期

To Compare the Efficacy of (Rifaximin + Mebeverine), (Rifaximin + Amitriptyline), and (Rifaximin + Psyllium Husk) in Irritable Bowel Syndrome Associated With Diarrhea

Bahria University1 个研究点 分布在 1 个国家目标入组 162 人开始时间: 2023年1月3日最近更新:
适应症
干预措施
相关药物

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

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 )

Active Comparator

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 )

Active Comparator

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 )

Active Comparator

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 )

Active Comparator

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 )

Active Comparator

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 )

Active Comparator

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

申办方类型
Other
责任方
Principal Investigator
主要研究者

Rashid Ali Khosa

Lecturer

Bahria University

研究点 (1)

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