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CTRI Number  CTRI/2020/07/026666 [Registered on: 17/07/2020] Trial Registered Prospectively
Last Modified On: 16/07/2020
Post Graduate Thesis  No 
Type of Trial  Interventional 
Type of Study   Drug 
Study Design  Randomized, Parallel Group, Placebo Controlled Trial 
Public Title of Study   Efficacy of antipsychotic for the treatment of people suffering from Irritable Bowel Syndrome with Diarrhoea 
Scientific Title of Study   A randomised trial of chlorpromazine for the treatment of irritable bowel syndrome with diarrhoea 
Trial Acronym   
Secondary IDs if Any  
Secondary ID  Identifier 
NIL  NIL 
 
Details of Principal Investigator or overall Trial Coordinator (multi-center study)  
Name  Vikhram Ramasubramanian  
Designation  Consultant Psychiatrist  
Affiliation  Ahana hospitals LLP 
Address  Ahana hospitals LLP Department of Psychiatry, Research Division, 11,Subburaman street, Madurai

Madurai
TAMIL NADU
625020
India 
Phone  9443772233  
Fax    
Email  vikhram@ahanahospitals.in  
 
Details of Contact Person
Scientific Query  
Name  Vikhram Ramasubramanian  
Designation  Consultant Psychiatrist  
Affiliation  Ahana hospitals LLP 
Address  Ahana hospitals LLP Department of psychiatry, Research Division, No.11,subburaman street Madurai

Madurai
TAMIL NADU
625020
India 
Phone  9443772233  
Fax    
Email  vikhram@ahanahospitals.in  
 
Details of Contact Person
Public Query  
Name  Vikhram Ramasubramanian  
Designation  Consultant Psychiatrist  
Affiliation  Ahana hospitals LLP 
Address  Ahana hospitals LLP Department of Psychiatry, Research Division, No.11,subburaman street Madurai

Madurai
TAMIL NADU
625020
India 
Phone  9443772233  
Fax    
Email  vikhram@ahanahospitals.in  
 
Source of Monetary or Material Support  
Ahana hospitals LLP 11, Subburaman street Madurai - 625020 
 
Primary Sponsor  
Name  Ahana Hospitals LLP 
Address  Ahana Hospitals LLP 11,subburam street, madurai 
Type of Sponsor  Private hospital/clinic 
 
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 
vikhram ramasubramanian  Ahana hospitals LLP  Department of psychiatry , Research division, No 11 , Subburaman street,
Madurai
TAMIL NADU 		 9443772233

vikhram@ahanahospitals.in 
 
Details of Ethics Committee  
No of Ethics Committees= 1  
Name of Committee  Approval Status 
Radiance healthcare and research  Approved 
 
Regulatory Clearance Status from DCGI  
Status 
Not Applicable 
 
Health Condition / Problems Studied  
Health Type  Condition 
Patients  (1) ICD-10 Condition: K580||Irritable bowel syndrome with diarrhea,  
 
Intervention / Comparator Agent  
Type  Name  Details 
Intervention  chlorpromazine  it is a first generation antipsychotics which is most commonly used in the treatment of schizophrenia. it is also a FDA approved drug for the treatment of intractable hiccups and vomiting. its antagonist action at the m1 and m2 muscarinic cholinergic receptor causes constipation which can be used to treat IBS-D at lower doses. Patients will be given 25 mg of chlorpromazine at night for 12 weeks  
Comparator Agent  Not applicable   not applicable 
 
Inclusion Criteria  
Age From  18.00 Year(s)
Age To  50.00 Year(s)
Gender  Both 
Details  Patients must fulfil all of the following criteria:

1.Meet Rome IV criteria for IBS-D

2.Age 18 - 50 years

3.Patients of childbearing potential or with partners of childbearing potential must agree to use methods of medically acceptable forms of contraception during the trial and for 90 days after completion of trial medication

4.Women of childbearing potential must test negative for pregnancy within 72 h of confirmation of eligibility

5.Weekly average worst pain score ≥ 30 on a 0–100-point scale

6.Stools with a consistency of 6 or 7 on the Bristol Stool Form Score (BSFS) for 2 or more days per week 
 
ExclusionCriteria 
Details  1.Gastrectomy

2.Intestinal resection;

3.Other known organic gastrointestinal diseases (e.g. inflammatory bowel disease (Crohn’s disease, ulcerative colitis));

4.Unable or unwilling to stop restricted medication including regular loperamide, antispasmodics (e.g. buscopan, mebeverine, peppermint oil, alverine citrate), eluxadoline, tricyclic antidepressant doses > 30 mg/day or other drugs likely in the opinion of the investigator to alter bowel habit. These medicines should be discontinued for a 7-day washout period prior to registration;

5.QTc interval ≥ 450 msec in men or ≥ 470 msec in women (assessed within the last 3 months by electrocardiogram (ECG));

6.Pulse, blood pressure, laboratory-tested blood values outside the normal ranges according to the site’s local definition of normal (assessed within the last 3 months). Note minor rises in alanine aminotransferase (ALT) (< 2 × upper limit of normal) will be acceptable, but the patient’s General Practitioner (GP) will be informed if ALT remains elevated at the end of the trial;

7.Women who are pregnant or breastfeeding;

8.Patients currently or previously participating in a trial of an investigational medicinal product (IMP) in the previous 3 months, where the use of the IMP may cause issues with the assessment of causality in this trial;


9.Patients with only stools of consistency 7 on the BSFS for 7 days a week.

10.Patients taking QT-prolonging or cardiotoxic drugs will be reviewed by the local Principal Investigator (PI) to determine whether they are suitable for the trial. 
 
Method of Generating Random Sequence   Computer generated randomization 
Method of Concealment   Not Applicable 
Blinding/Masking   Not Applicable 
Primary Outcome  
Outcome  TimePoints 
The primary outcome measure is to ascertain whether 12 weeks of Chlorpromazine increases the FDA-defined responder rate (in relation to abnormal defaecation and abdominal pain) compared with placebo.   Baseline,4 weeks , 8 weeks ,12 weeks  
 
Secondary Outcome  
Outcome  TimePoints 
a)Stool consistency and abdominal pain (measured by diary and daily text message)

b)Stool frequency, urgency of defaecation, and use of rescue medication (defined as the use of loperamide) over 12 weeks of treatment and the answer to the question “Overall, have you had satisfactory relief from your IBS symptoms in the past week?” (measured by diary);

c)IBS symptom severity (measured by the Irritable Bowel Syndrome Severity Scale
 		 baseline and at the end of the study 
 
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   N/A 
Date of First Enrollment (India)   17/07/2020 
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="0"
Months="6"
Days="0" 
Recruitment Status of Trial (Global)   Not Applicable 
Recruitment Status of Trial (India)  Not Yet Recruiting 
Publication Details   Nil 
Individual Participant Data (IPD) Sharing Statement

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

Brief Summary   Irritable bowel syndrome with diarrhoea (IBS-D) affects up to 4 % of the population. The symptoms include frequent, loose or watery stools with associated urgency, resulting in a marked reduction of quality of life and loss of productivity. Chlorpromazine,a D2 receptor antagonist with combined action in Histaminic and muscarinic receptor which is widely used as an antipsychotic drug with a notorious side effect such as constipation can be used in the treatment of IBS-D at lower doses 
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