Health Condition 1: K519- Ulcerative colitis, unspecified
Conditions
Interventions
Intervention1: Amitriptyline: Initial dose of 10 mg/day titrated to 25 mg/day over a period of two weeks, 25 mg/day maintained for 3 months
Control Intervention1: Placebo: Size, shape and taste matche
Sponsors
Department of Gastroenterology AIIMS Delhi
Eligibility
Inclusion criteria
Inclusion criteria: 1. Patients who are confirmed cases of mild to moderate Ulcerative Colitis as assessed by SCCAI score (3-9) 2. Endoscopically active disease (UCEIS more than 1) or fecal calprotectin more than 150 µg/g. 3. Age: 18 – 70 years 4. Patients who are on optimum dosage of oral (minimum 2.4 g per day) and topical 5-ASA agents, are oral steroid naïve or experienced (last dose more than 8 weeks prior) but not on Steroids. 5. Anti-TNF/Anti-integrin naïve or experienced (intolerant or non-responder) but last dose =2 months back. 6. Concomitant therapy allowed - a. Topical steroid and topical 5-ASA therapy (if stable for last 2 weeks) b. Patients on stable doses of oral 5-ASA (5-amino salicylic acid) for past 2 weeks. c. Patients on stable doses of azathioprine for past 2 weeks. d. Patients on advanced therapy (stable doses of biologicals, tofacitinib or vedolizumab for past 8 weeks) 7. Women of childbearing age should agree to avoid conception during the study period. 8. Patients giving written informed consent
Exclusion criteria
Exclusion criteria: 1. Severe disease SCCAI more than or equal to 10 2. Patients with fulminant colitis requiring hospitalization 3. Use of oral steroids, antibiotics, Anti-TNF/Anti-integrin agents, small molecule inhibitors within the past 8 weeks. 4. Patients with surgical intervention for IBD, on psychiatric medication or pregnant and lactating women 5. Patients with bipolar, psychotic, substance use disorders, major depressive disorder or anxiety disorders. 6. Patients with Severe comorbid medical illness a. Cardiac: NYHA II or higher congestive heart failure b. Renal: Creatine clearance (Cockcroft Gault formula) less than 40 ml/min c. Severe hepatic impairment d. Malignancies or a history of malignancies e. Significant trauma or major surgery within 4 weeks f. History of bowel surgery within 6 months
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Rates of clinical remission at 12 weeks, defined as SCCAI score =2 with all sub-scores =1 in both groups.Timepoint: 12 weeks | — |
Secondary
| Measure | Time frame |
|---|---|
| Biochemical remission at 12 weeks defined as fecal calprotectin less than 150 µg/g.Timepoint: 12 weeks; Effect of amitriptyline versus placebo on the quality of life (WHOQOL BREF) Timepoint: 12 weeks;2. Clinical response at 12 weeks, defined as reduction in SCCAI score by =3 points or by 30% reduction in SCCAI score from baseline in both groups.Timepoint: 12 weeks;3. Treatment failure, defined as increase in SCCAI score by more than or equal to 3 points with all sub scores more than or equal to 1 points.Timepoint: 12 weeks;4. Endoscopic response and remission at 12 weeks defined as decline in UCEIS by 2 points and UCEIS of less than or equal to 1 points respectively points respectively.Timepoint: 12 weeks;5. Deep remission at 12 weeks defined as a combination of clinical and endoscopic remission.Timepoint: 12 weeks;7. Adverse events at 12 weeks in both groups: nausea, drowsiness, anti-cholinergic side effects (constipation, xerostomia, blurred vision, and urinary retention), and ECG abnormalities (QTc prolongation)Timepoint: 12 weeks | — |
Countries
India
Contacts
Public ContactAmitkumar Chavan
All India Institute of Medical Sciences, New Delhi
Outcome results
None listed