"A prospective, open label, single contre & Placcbo controlled study for evaluation of efficacy & safety of Gutbio Plus capsule for chronic constipation & its symptoms."
概览
- 阶段
- 4 期
- 状态
- 进行中（未招募）
- 发起方
- Healing Hands & Herbs Pvt.Ltd.
- 入组人数
- 60
- 试验地点
- 1
- 主要终点
- Overall Complete Spontaneous Bowel Movement Response.
概览
简要总结
The study is a Prospective, open-label, single-center and placebo-controlled for the evaluation of the efficacy and Safety of the GutBio Plus Capsule for chronic constipation and its symptoms.
Eligible patients both male and female Aboe18 years of age with symptomatic Functional constipation, Abdominal Pain and bloating will be enrolled in the study. The treating physician will make the decision to prescribe the GutBio Plus Capsule as per clinical judgment.
Medical history will be obtained and a physical examination will be conducted for each patient by the study investigators. The treatment duration is 29 Days and the Post-treatment period is 14 Days. Patients will be followed up till the end of the study (Day 43).
At screening (Day 1 or 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.
A total of 60 subjects will be enrolled in the study. 45 subjects will receive GutBio Plus Capsules twice daily and 15 subjects will receive Placebo capsules twice daily or as per physician discretion. The subject would be informed to visit the clinic after 07 Days (Visit 2), 15 Days (Visit 3), 29 Days (Visit 4) and 43 Days (Visit 5) for Post-treatment follow-up. Safety assessment will be done throughout the study duration. At clinic visits spirometry, medical examination will be performed, AEs will be recorded, vital signs will be evaluated and changes in medication will be recorded, and compliance will be checked with study medication. Patients will be instructed to take their daily dose of study medication on the days of the clinic visits, as these doses will be administered at the clinic under the supervision of study personnel.
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 90.00 Year(s)（—）
- 性别
- All
入选标准
- •Patients aged above 18 years of age.
- •Patient with a diagnosis of chronic constipation
- •Patient or Parents or legal guardian willing to give a written informed consent or parental consent or assent form.
- •Able to Willing to strictly adhere to the investigator’s prescription.
排除标准
- •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.
- •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.
- •Subjects with a history of unexplained weight loss or rectal bleeding.
- •Female subjects who are pregnant or lactating or planning to become pregnant during the study period.
- •Females who are not ready to use acceptable contraceptive methods during the course of study.
结局指标
主要结局
Overall Complete Spontaneous Bowel Movement Response.
时间窗: Upto fifth visit.
次要结局
- 1. evaluate the Gastrointestinal Quality of Life Index of Patients suffering from Functional constipation, abdominal pain and bloating.(2. Number of Participants with Treatment-Related Treatment-Emergent Adverse Events.)
研究者
Dr Ashwin Porwal
Healing Hands Clinic