Health Condition 1: null- Inflammatory Bowel disease patients (Ulcerative colitis)
Conditions
Interventions
Intervention1: 5 Aminosalicylic acid or Placebo: 2 gram of 5 ASA or 2 gram of Placebo for 12 months
Sponsors
No
Eligibility
Inclusion criteria
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
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
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| 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
| Measure | Time frame |
|---|---|
| provide invaluable data to international guideline committees on the management of Ulcerativecolitis patients.Timepoint: Secondary endpoints include: - predictive factors for disease relapse - relapse rates at 24 and 36 months - patientsâ?? compliance - adverse events | — |
Countries
India
Contacts
Public ContactVINEET AHUJA
ALL INDIA INSTITUTE OF MEDICAL SCIENCES
Outcome results
None listed