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CTRI Number  CTRI/2024/08/071932 [Registered on: 05/08/2024] Trial Registered Prospectively
Last Modified On: 30/07/2024
Post Graduate Thesis  Yes 
Type of Trial  Interventional 
Type of Study   Drug 
Study Design  Randomized, Parallel Group, Placebo Controlled Trial 
Public Title of Study   Amitriptyline versus placebo for inducing remission in patients with mild to moderate ulcerative colitis 
Scientific Title of Study   Efficacy of amitriptyline in inducing remission in patients with mild to moderate ulcerative colitis: A double-blind, randomized placebo-controlled trial 
Trial Acronym  NIL 
Secondary IDs if Any  
Secondary ID  Identifier 
NIL  NIL 
 
Details of Principal Investigator or overall Trial Coordinator (multi-center study)  
Name  Vineet Ahuja 
Designation  Professor 
Affiliation  All India Institute of Medical Sciences, New Delhi 
Address  Department of Gastroenterology, 3rd floor, teaching block, AIIMS, Ansari Nagar South Delhi, 110029, India

South
DELHI
110029
India 
Phone  9810707170  
Fax    
Email  vineet.aiims@gmail.com  
 
Details of Contact Person
Scientific Query  
Name  Vineet Ahuja 
Designation  Professor 
Affiliation  All India Institute of Medical Sciences, New Delhi 
Address  Department of Gastroenterology, 3rd floor, teaching block, AIIMS, Ansari Nagar South Delhi, 110029, India

South
DELHI
110029
India 
Phone  9810707170  
Fax    
Email  vineet.aiims@gmail.com  
 
Details of Contact Person
Public Query  
Name  Amitkumar Chavan 
Designation  Senior Resident 
Affiliation  All India Institute of Medical Sciences, New Delhi 
Address  Department of Gastroenterology, 3rd floor, teaching block, AIIMS, Ansari Nagar South Delhi, 110029, India

South
DELHI
110029
India 
Phone  8660896882  
Fax    
Email  dramitchavan921@gmail.com  
 
Source of Monetary or Material Support  
All India Institute of Medical Sciences, New Delhi 
Intas Pharmaceuticals 
 
Primary Sponsor  
Name  Department of Gastroenterology AIIMS Delhi 
Address  Room 3093 Department of Gastroenterology AIIMS New Delhi Ansari Nagar PIN 110049 New Delhi India 
Type of Sponsor  Government medical college 
 
Details of Secondary Sponsor  
Name  Address 
NIL  NIL 
 
Countries of Recruitment     India  
Sites of Study  
No of Sites = 1  
Name of Principal Investigator  Name of Site  Site Address  Phone/Fax/Email 
Prof Vineet Ahuja  All India Institute of Medical Sciences, New Delhi  Department of Gastroenterology, Room 3093, 3rd floor teaching block, AIIMS, Sri Aurobindo Marg, Ansari Nagar East, New Delhi, 110029 South Delhi
South
DELHI 		 9810707170

vineet.aiims@gmail.com 
 
Details of Ethics Committee  
No of Ethics Committees= 1  
Name of Committee  Approval Status 
Institute ethics committee for post graduate research. All India Institute of Medical Sciences  Approved 
 
Regulatory Clearance Status from DCGI  
Status 
Not Applicable 
 
Health Condition / Problems Studied  
Health Type  Condition 
Patients  (1) ICD-10 Condition: K519||Ulcerative colitis, unspecified,  
 
Intervention / Comparator Agent  
Type  Name  Details 
Intervention  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 
Comparator Agent  Placebo  Size, shape and taste matched placebo tablets. Route: per oral. Dose: Initial dose of 10 mg/day titrated to 25 mg/day over a period of two weeks, 25 mg/day maintained for 3 months 
 
Inclusion Criteria  
Age From  18.00 Year(s)
Age To  70.00 Year(s)
Gender  Both 
Details  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
 
 
ExclusionCriteria 
Details  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
 
 
Method of Generating Random Sequence   Computer generated randomization 
Method of Concealment   Sequentially numbered, sealed, opaque envelopes 
Blinding/Masking   Participant and Investigator Blinded 
Primary Outcome  
Outcome  TimePoints 
Rates of clinical remission at 12 weeks, defined as SCCAI score ≤2 with all sub-scores ≤1 in both groups.  12 weeks 
 
Secondary Outcome  
Outcome  TimePoints 
Effect of amitriptyline versus placebo on the quality of life (WHOQOL BREF)

 		 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.  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.  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.   12 weeks 
5. Deep remission at 12 weeks defined as a combination of clinical and endoscopic remission.   12 weeks 
Biochemical remission at 12 weeks defined as fecal calprotectin less than 150 μg/g.   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)  12 weeks 
 
Target Sample Size   Total Sample Size="100"
Sample Size from India="100" 
Final Enrollment numbers achieved (Total)= "Applicable only for Completed/Terminated trials"
Final Enrollment numbers achieved (India)="Applicable only for Completed/Terminated trials" 
Phase of Trial   Phase 3 
Date of First Enrollment (India)   10/08/2024 
Date of Study Completion (India) Applicable only for Completed/Terminated trials 
Date of First Enrollment (Global)  Date Missing 
Date of Study Completion (Global) Applicable only for Completed/Terminated trials 
Estimated Duration of Trial   Years="2"
Months="0"
Days="0" 
Recruitment Status of Trial (Global)   Not Applicable 
Recruitment Status of Trial (India)  Not Yet Recruiting 
Publication Details   N/A 
Individual Participant Data (IPD) Sharing Statement

Will individual participant data (IPD) be shared publicly (including data dictionaries)?  

Response - NO
Brief Summary   Amitriptyline is often used to treat somatic symptoms in IBD, but there is evidence that it has some anti-inflammatory effects which may explain its efficacy in improving symptoms of Ulcerative Colitis (UC). Currently, there is a paucity of quality evidence regarding the efficacy of anti-depressant medications in UC.  Hence this study aims to explore the efficacy and safety of amitriptyline in patients with mild –moderate UC. 
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