CTRI/2022/09/046036进行中（未招募）未知
A randomized, double-blind, placebo-controlled study to evaluate the efficacy and tolerability of a novel herbal composition to relieve constipation and to improve bowel clearance in healthy subjects
Bohan and Co0 个研究点目标入组 0 人开始时间: 待定最近更新:
试验速览
- 阶段
- 未知
- 状态
- 进行中（未招募）
- 发起方
研究概览
简要总结
暂无简介。
研究设计
- 研究类型
- Interventional
入排标准
入选标准
- •1. Male and female subjects aged between 25 and 60 years with BMI of 20 to 29 kg/m2.
- •2. Subjects meet the following Rome-IV diagnostic criteria for Functional constipation:
- •i.Must include two or more of the following:
- •a.Straining during more than ¼ (25%) of defecations
- •b.Lumpy or hard stools (Bristol Stool Form Scale 1-2) more than ¼ (25%) of defecations
- •c.Sensation of incomplete evacuation more than ¼ (25%) of defecations
- •d.Sensation of anorectal obstruction/blockage more than ¼ (25%) of defecations
- •e.Manual maneuvers to facilitate more than ¼ (25%) of defecations (e.g., digital evacuation, support of the pelvic floor)
- •f.Fewer than three SBM per week
- •g.Loose stools are rarely present without the use of laxatives
- •h.Insufficient criteria for irritable bowel syndrome
- •i.(NOTE: Criteria fulfilled for the last 3 months with symptom onset at least 6 months prior to diagnosis)
- •3.Female subjects of childbearing potential must be using a medically acceptable form of birth control. Post-menopausal subjects must be amenorrheic for at least 1 year or had a hysterectomy and/or bilateral oophorectomy.
- •4.Ability to understand the risks/benefits of the protocol and willing to sign the written informed consent.
- •5.Subjects agree to be available for regular follow up throughout the study duration.
- •6.Subject considered generally healthy as per health history and routine clinical investigations during screening.
排除标准
- •1.Subjects with secondary constipation (caused by medical condition or medication use).
- •2.Use of drugs or supplements for gastrointestinal motility or laxatives.
- •3.Subjects underwent treatment for COVID 19 within last 3 months or tested positive during the study will be excluded.
- •4.Use of dietary supplements like prebiotics or probiotics.
- •5.Subjects with history of medical conditions like cerebrovascular disease, depression, hypothyroidism, Irritable bowel syndrome or taking medicines like Antacids, Iron supplements, Opioids etc.
- •6.Women who are pregnant, lactating or planning to become pregnant during the study duration.
- •7.Subjects with any disease or abnormalities related to gastrointestinal tract, pancreas and liver.
- •8.Subjects with hypertension and diabetes
- •9.Evidence or history of hematological, renal, endocrine, pulmonary, gastrointestinal, cardiovascular, hepatic, neurologic diseases, malignancies.
- •10.Subjects consuming alcohol or smokers.
- •11.History of psychiatric disorder that may impair the ability of subjects to provide written informed consent.
- •12.Expectation of any surgery during the study period.
- •13.Subject has participated in a clinical study within the last 30 days prior to recruitment or currently participating in another study.
- •14.Subjects with a known allergy or sensitivity to herbs/spices/plant products in general and/or allergic to botanical ingredients contained in the study product.
- •15.Any other condition that, in the opinion of the investigator, would adversely affect the subjectâ??s ability to complete the study or its measures
研究者
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