Effect of herbal formulation (Divya Cologrit Enteric-coated tablets) in inflammatory bowel disease.
Phase 3
- Conditions
- Health Condition 1: K509- Crohns disease, unspecified
- Registration Number
- CTRI/2023/08/056244
- Lead Sponsor
- Patanjali Research Institute governed by Patanjali Research Foundation Trust
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- ot Yet Recruiting
- Sex
- Not specified
- Target Recruitment
- 0
Inclusion Criteria
Subject with known case of Inflammatory Bowel Disease (IBD).
Male and female of 18 years to 65 years.
Capability of complete compliance and completion of follow-up.
Willingness to provide written informed consent.
Exclusion Criteria
The subject with complications and requires surgical intervention.
The subject with a known history of any malignancy, uncontrolled diabetes mellitus, psychiatric disorders, or with complications of Cardiovascular disease, liver disease or Kidney disorders.
Pregnancy or lactation, intention to pregnancy.
History of alcoholism or substance abuse.
The subject not willing to provide consent.
The subject not willing to comply with the protocol.
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method To evaluate the benefit treatment regime on symptomatic improvement in IBD Symptom Inventory (IBDSI)-Long Form.Timepoint: Baseline to Day 60
- Secondary Outcome Measures
Name Time Method To evaluate the benefit treatment regime on IBD Symptom Inventory (IBDSI)-Long Form and Short Form-12 (SF-12).Timepoint: Baseline to Day 60