CTRI/2022/09/046036
Active, not recruiting
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 sites0 target enrollmentTBD
Overview
- Phase
- 未知
- Intervention
- Not specified
- Conditions
- Not specified
- Sponsor
- Bohan and Co
- Status
- Active, not recruiting
- Last Updated
- 3 years ago
Overview
Brief Summary
No summary available.
Investigators
Eligibility Criteria
Inclusion Criteria
- •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
Exclusion Criteria
- •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.
Outcomes
Primary Outcomes
Not specified
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