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.
- 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
Recruitment & Eligibility
- Status
- Not Yet Recruiting
- Sex
- Not specified
- Target Recruitment
- 194
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
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
- Secondary Outcome Measures
Name Time Method