Health Condition 1: K519- Ulcerative colitis, unspecified
Conditions
Interventions
None listed
Sponsors
Indian Council of Medical Research
Eligibility
Inclusion criteria
Inclusion criteria: 1 Confirmed cases of mild to moderate endoscopically active ulcerative colitis (UC endoscopic index of severity or UCEIS more than 1) and disease extent beyond rectum and simple clinical colitis activity score between 3-9 2 Patients on stable dose of mesalamine for past 4 weeks 3 Patients on stable dose of azathioprine or 6 mercaptopurine for past 3 months 4 Patients on stable doses of topical therapy for past 2 weeks 5 willing to participate
Exclusion criteria
Exclusion criteria: 1 history of oral steroids in the past 4 weeks 2 History of or oral antibiotics within past 2 weeks 3 Patients with severe disease activity 4 Patients with fulminant colitis requiring hospitalization 5 Patients who have had surgery 6 Patients with Crohns colitis 7 Patients with concomitant GI infection 8 Patients with comorbidities like acute myocardial infarction chronic kidney disease or chronic liver disease 9 Patients with significant hepatic renal endocrine respiratory neurologic or cardiovascular diseases will also be excluded 10 Pregnant lactating females 11 Patients with allergy to Ayurvedic formulations 12 Patients with Diabetes 13 Patients with severe co-morbidities
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Clinical remission defined as SCCAI less than equal to 2Timepoint: 8 weeks and 48 weeks | — |
Secondary
| Measure | Time frame |
|---|---|
| Clinical Response Timepoint: at 8 and 48 weeks;Endoscopic response and remissionTimepoint: 8 and 48 weeks;Deep RemissionTimepoint: 8 and 48 weeks;Quality of LifeTimepoint: 8 and 48 weeks;Adverse eventsTimepoint: 8 and 48 weeks | — |
Countries
India
Contacts
Public ContactDr Gautam Sharma
AIIMS Delhi
Outcome results
None listed