A clinical trial to study the effects of stopping of 5-aminosalicylic Acid in Ulcerative colitis patients who are in inactive stage of disease for a long duration.

Not Applicable

• Conditions: Health Condition 1: null- Inflammatory Bowel disease patients (Ulcerative colitis)

• Registration Number: CTRI/2017/05/008483
• Lead Sponsor: o

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: ot Yet Recruiting
• Sex: Not specified
• Target Recruitment: 194

Inclusion Criteria

1. At least 18 years old

2. Have a confirmed diagnosis of UC according to established clinical, endoscopic and histologic criteria

3. On oral mesalazine or salphasalazine

4. in steroid-free clinical remission for at least 1 year

5. Stable doses of immunosuppressants for at least 3 months if immunosuppressants are used

6. Written informed consent

Exclusion Criteria

Patients are excluded if they have one or more of the following conditions:

1. allergic to mesalazine

2. Prior bowel surgery except appendectomy

3. on anti-TNF therapy

4. Concomitant primary sclerosing cholangitis

5. Hepatic or renal dysfunction

6. Malignant disease within 5 years

7. Pregnancy or breast feeding or women of child-bearing age without regular use of contraception

8. Terminal illness

Study & Design

• Study Type: Interventional
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
We will get to know more about the outcomes of discontinuation of ASA in long-term inactive Ulcerative colitis patients. This study would also give a lot of invaluable information as to how to manage long-term inactive UC patients who discontinued ASA treatment.Timepoint: 12 months

Secondary Outcome Measures

Name	Time	Method
provide invaluable data to international guideline committees on the management of Ulcerativecolitis patients.Timepoint: Secondary endpoints include: <br/ ><br> <br/ ><br>- predictive factors for disease relapse <br/ ><br> <br/ ><br>- relapse rates at 24 and 36 months <br/ ><br> <br/ ><br>- patientsâ?? compliance <br/ ><br> <br/ ><br>- adverse events <br/ ><br>