A study to compare the effectiveness and safety of high standard dose with low start up dose strategy of azathioprine in patients with ulcerative colitis.
Not Applicable
- Conditions
- Health Condition 1: K510- Ulcerative (chronic) pancolitisHealth Condition 2: K512- Ulcerative (chronic) proctitisHealth Condition 3: K513- Ulcerative (chronic) rectosigmoiditis
- Registration Number
- CTRI/2020/05/025281
- Lead Sponsor
- Mukesh Kumar Ranjan
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- ot Yet Recruiting
- Sex
- Not specified
- Target Recruitment
- 0
Inclusion Criteria
Confirmed cases of ulcerative colitis.
1)Age 18-80 years.
2)Willing to give informed consent.
3)Ulcerative colitis patients who are steroid dependent.
4)Ulcerative colitis patients who are steroid refractory.
5)Patients with acute severe ulcerative colitis (ASUC) after complete response to initial systemic steroid therapy.
Exclusion Criteria
1)Severe cardiac, hepatic and/or renal insufficiency.
2)Active tuberculosis.
3)History of malignancy in last three years.
4)Active viral hepatitis.
5)Comorbidity such as bacterial or viral infection that has not been controlled effectively.
6)Pregnancy.
7)HIV infection.
8)Patients not willing to give consent.
9)Patients with homozygous NUDT 15 and TPMT variant polymorphism.
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method 1)Steroid free clinical response at 6 months. <br/ ><br>2)Steroid free clinical remission at 6 months. <br/ ><br>3)Steroid free endoscopic remission at 6 months. <br/ ><br>Timepoint: At 6 months of treatment with azathioprine <br/ ><br>
- Secondary Outcome Measures
Name Time Method 1)Steroid free endoscopic response at 6 months. <br/ ><br>2)Steroid free histological remission at 6 months. <br/ ><br>3)Correlation of base line fecal microbiome profile with response to treatment with azathioprine at 6 months. <br/ ><br>4)Adverse events at 3 months and 6 months. The major adverse events will include: <br/ ><br>-Myelotoxicity <br/ ><br>-Hepatotoxicity <br/ ><br>-Acute pancreatitis <br/ ><br>-Gastrointestinal intolerance <br/ ><br>-Skin manifestations <br/ ><br>Timepoint: At 6 months of treatment with azathioprine