Skip to content

Ayurvedic Formulation and Lifestyle Changes for mild to moderate Crohn s Disease: A Multicenter Clinical Trial

Multicenter double blind placebo (dummy) controlled randomized trial of treatment with ayurvedic formulation and life style modification in patients with mild to moderate Crohn s disease. - NIL

Status
Active, not recruiting
Phases
Phase 2Phase 3
Study type
Interventional
Source
CTRI
Registry ID
CTRI/2025/06/088142
Enrollment
92
Registered
2025-06-03
Start date
Unknown
Completion date
Unknown
Last updated
2025-06-24

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Health Condition 1: K508- Crohns disease of both small andlarge intestine

Interventions

None listed

Sponsors

Indian Council of Medical Research
Lead Sponsor

Eligibility

Inclusion criteria

Inclusion criteria: Crohns disease

Exclusion criteria

Exclusion criteria: 1. Patients with proximal small bowel disease (i.e. L4 disease) 2. Patients with severe disease activity 3. Patients with symptomatic strictures 4. Patients with H/O of antibiotic exposure in the past 6 weeks 5. Patients with active perianal disease 6. Patients with abdominal abscess/ intestinal fistulae/ acute obstruction 7. Prior intestinal surgery (subtotal or total colectomy, ileostomy, colostomy) or patients planned for surgery (known fixed symptomatic stenosis or complex fistulae) 8. Patients requiring hospitalization 9. Pregnant, lactating females 10. Patients with Diabetes 11. Patients with significant hepatic, renal, endocrine, respiratory, neurologic, or cardiovascular diseases will also be excluded 12. Patients with comorbidities like acute myocardial infarction, chronic kidney disease or chronic liver disease 13. Patients with allergy to Ayurvedic formulations

Design outcomes

Primary

MeasureTime frame
Clinical remission defined as SCCAI less than equal to 2Timepoint: 12 and 52 weeks

Secondary

MeasureTime frame
Clinical response Endoscopic remission and response Quality of life Adverse eventsTimepoint: 12 and 52 weeks

Countries

India

Contacts

Public ContactDr Gautam Sharma

All India Inistitute of Medical Sciences, New Delhi

drgautamsharma12@gmail.com26594681

Outcome results

None listed

Source: CTRI (via WHO ICTRP) · Data processed: Feb 4, 2026