Prospective Open-label and Single-Center study for evaluation of efficacy and safety of Gutbio Capsule for Irritable Bowel Syndrome and its symptoms.
试验速览
- 阶段
- 4 期
- 状态
- 进行中（未招募）
- 发起方
- 入组人数
- 100
- 试验地点
- 1
- 主要终点
- Evaluate the improvement in the Irritable Bowel Syndrome- Symptom Severity Score, IBS-Adequate relief, Gastrointestinal symptom rating scale, Complete Spontaneous Bowel Movement and Stool consistency of GutBio capsule.
研究概览
简要总结
The study is a Prospective, open-label, and single-center study for evaluation of efficacy and safety of GutBio Capsule for irritable bowel syndrome and its symptomsâ€.
Eligible patients, both male and female above 18 years of age with symptomatic IBS, will be enrolled in the study. The decision to prescribe a GutBio Capsule will be made by the treating physician as per clinical judgment.
A detailed medical history will be obtained and a physical examination will be conducted for each patient by the study investigators. The total treatment duration is 4 weeks and patients will be followed up till the end of the study visit i.e Visit 5. Day 43.
At screening (Day -1 to Day 0), the potential patients will be identified by the site team, and written informed consent (for patients aged 18 years and above will be procured before any study-related procedures are undertaken. The assessment, as per the schedule of assessments , would be performed at screening and enrolment to determine eligibility.
A total of 100 subjects will be enrolled in the study. 100 subjects will receive GutBio Capsules twice daily as per physician discretion. The subject would be informed to visit the clinic on Day 8 (Visit 2), Day 15 (Visit 3), Day 29 (Visit 4), and Day 43 (visit 5). Safety assessment will be done throughout the duration of the study.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 盲法
- None
入排标准
- 年龄范围
- 18.00 Year(s) 至 95.00 Year(s)（—）
- 性别
- All
入选标准
- •1.Patients aged 18 years & above.
- •2.Patient with a diagnosis of irritable bowel syndrome.
- •3.Patient or Parent or legal guardian willing to give a written informed consent or parental consent or assent form.
- •4.Able to or Willing to strictly adhere to the investigator’s prescription.
排除标准
- •1.Individuals were excluded if they had taken any medications that might interfere with the action of the study medications prior to the start of the study or during the study.
- •2.Subjects with a history of coeliac disease, Inflammatory Bowel disease, bowel cancer, bariatric surgery or surgical resection of the stomach, small intestine, or large intestine.
- •3.Subjects with a history of unexplained weight loss or rectal bleeding.
- •4.Female subjects who are pregnant or lactating or planning to become pregnant during the study period.
- •5.Females who are not ready to use acceptable contraceptive methods during the course of study.
结局指标
主要结局
Evaluate the improvement in the Irritable Bowel Syndrome- Symptom Severity Score, IBS-Adequate relief, Gastrointestinal symptom rating scale, Complete Spontaneous Bowel Movement and Stool consistency of GutBio capsule.
时间窗: Upto Visit 5 (Day-43)
次要结局
- 1.Evaluate the improvement in the Hamilton Anxiety Rating Scale, Hamilton Depression,Rating Scale and IBS-QoL Questionnaire.
研究者
Dr Ashwin Porwal
Healing Hands Clinic Pvt Ltd.