A clinical study to evaluate the efficacy and tolerability of a novel herbal composition to relieve constipation and to improve bowel clearance
- Conditions
- Health Condition 1: K590- Constipation
- Registration Number
- CTRI/2022/09/046036
- Lead Sponsor
- Bohan and Co
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Closed to Recruitment of Participants
- Sex
- Not specified
- Target Recruitment
- 0
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.
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
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method
- Secondary Outcome Measures
Name Time Method