Role of Bismuth Citrate in Irritable Bowel Syndrome Diarrhoea
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 62
- 试验地点
- 1
- 主要终点
- 1) To evaluate improvement in abdominal pain using 11 points NRS scale.
研究概览
简要总结
This will be a prospective interventional , open labelled, randomized, parallel group active controlled trial. This study aim to evaluate the efficacy of Bismuth subcitrate with Rifaximin. In this study 68 adults will be enrolled . Participants will be screened and eligible participants will be enrolled in the study. Study duration of this study will be 8 months.
After randomization , all patients shall be given standard medical treatment (Tablet Mebeverine – 135 mg twice a day for 14 days) for IBS diarrhoea. In addition to that, patients will be randomised into two groups. Patients in the 1st group will receive standard care along with Tablet Rifaximin 550 mg twice a day (Group A) and patients in the 2nd group will receive standard care with Tablet Bismuth subcitrate 120 mg twice a day for 14 days(Group B) .
Follow up visits of patients will be seven (four phisical visits and three telephonically visits).
Primary Objective:
1) 1) To evaluate improvement in abdominal pain using 11 points NRS scale.
2) 2) To evaluate improvement in BSFS.
Secondary Objective:
1) 1) To evaluate the responder rates for abdominal pain and stool abnormalities separately.
2) 2)To evaluate stool frequency (CSBM and SBM) and stool consistency in both arms.
3) 3)To evaluate abdominal pain and the evaluation of the number of pain free days.
4) 4) To evaluate the numerical and responder on abdominal discomfort and bloating.
5) 5) To evaluate urgency of defecation, distension.
Data on the quality of life and IBS symptoms (severity of abdominal pain, severity of bloating and abdominal discomfort, and improvement of stool form) will be recorded by completing the IBS questionnaire by the patients.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 盲法
- None
入排标准
- 年龄范围
- 18.00 Year(s) 至 49.00 Year(s)（—）
- 性别
- All
入选标准
- •Patients with IBS-D aged 18–49 years, 2) Diagnosed according to the Rome IV criteria.
排除标准
- •Old aged patients ( more than 50yrs) 2) Pregnant women 3) Documented chronic heart or liver failure 4) Surgery on the gastrointestinal tract except appendectomy 5) Malabsorption diseases 6) Hyperthyroidism, Diabetes mellitus 7) Inflammatory bowel diseases 8) Connective tissue diseases 9) Use of antibiotic drugs within 1 month before the study 10) Significant weight loss, fever, and bloody stools 11) Lost to follow up 12) Drugs affecting gut motility.
结局指标
主要结局
1) To evaluate improvement in abdominal pain using 11 points NRS scale.
时间窗: 1) visit 3 -2nd week( site visit) | 2) Visit 5- 4th week ( site visit) | 3) Visit 7 - 3rd month( site visit)
2) To evaluate improvement in BSFS.
时间窗: 1) visit 3 -2nd week( site visit) | 2) Visit 5- 4th week ( site visit) | 3) Visit 7 - 3rd month( site visit)
次要结局
- 1) To evaluate the responder rates for abdominal pain & stool abnormalities separately.(2) To evaluate stool frequency (CSBM & SBM) & stool consistency in both arms.)
研究者
Amol Dahale
Dr D.Y. Patil Medical Hospital and Research Institute