Role of curcumin curcumin (NCB02) enemas in treating ulcerative colitis.

Phase 2

Completed

• Conditions: Health Condition 1: null- Active distal ulcerative colitis

• Registration Number: CTRI/2011/04/001695
• Lead Sponsor: Dr Vinnet Ahuja

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Last Update Posted: 24 November 2021

Recruitment & Eligibility

• Status: Completed
• Sex: Not specified
• Target Recruitment: 96

Inclusion Criteria

1.Adult patients

2. Mild-to-moderately active proctitis and proctosigmoiditis (Ulcerative Colitis Disease Activity Index [UCDAI] score, 3-9), with endoscopic disease extent up to 25 cm from the anal verge

3.Patients receiving mesalamine if the dose is stable for more than 8 weeks

Exclusion Criteria

1.Patients receiving rectal mesalamine or steroids during last 4 weeks

2.Disease extent more than proctosigmoiditis, evidence of severe disease (UCDAI more than 10)

3.Steroid initiation/dose escalation within the past 2 weeks,

4. Azathioprine initiation in past 6 months or change in dose of azathioprine in last 3 months.

5.History of Patients started on mesalamine in the past 8 weeks.

6. Patients requiring hospitalization and imminent need for surgery

7.Lactating and pregnant women

8.Patients received any investigational medicines within 3 months

9.Patients with significant hepatic, renal, endocrine, respiratory, neurologic, or cardiovascular diseases

Study & Design

• Study Type: Interventional
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
The primary outcome measure was improvement in activity of UC. This was defined as a decrease in the UCDAI by equal or more than 3 from baselineTimepoint: 8 weeks

Secondary Outcome Measures

Name	Time	Method
Secondary outcome measures were proportion of patients achieving remission and mucosal healingTimepoint: 8 week