| CTRI Number |
CTRI/2024/01/061210 [Registered on: 08/01/2024] Trial Registered Prospectively |
| Last Modified On: |
28/12/2023 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Homeopathy |
| Study Design |
Randomized, Parallel Group, Active Controlled Trial |
|
Public Title of Study
|
Effect of Chlorpromazinum on schizophrenia (EChloS) |
|
Scientific Title of Study
|
Effectiveness of Ultra high dilution of Chlorpromazinum compared to Individualized Homoeopathic Medicine in reducing Positive symptoms of Schizophrenia - A Single Blind Randomized Controlled Trial |
| Trial Acronym |
EChloS |
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Dr S Sudheer Kumar |
| Designation |
Postgraduate Scholar-Department of Psychiatry |
| Affiliation |
National Homoeopathy Research Institute in Mental Health |
| Address |
PG scholar-Department of Psychiatry, National Homoeopathy Research Institute in Mental Health, Sachivothamapuram P.O., Kottayam, Kerala-686532
Kottayam
KERALA
686532
India |
| Phone |
09746239662 |
| Fax |
|
| Email |
drsudheer1996@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Deepthi Gilla |
| Designation |
Associate Professor, Research Officer, Scientist-II Department of Psychiatry |
| Affiliation |
National Homoeopathy Research Institute in Mental Health |
| Address |
Department of Psychiatry, Room No. 106(4), National Homoeopathy Research Institute in Mental Health, Sachivothamapuram P.O., Kottayam, Kerala-686532
Kottayam
KERALA
686532
India |
| Phone |
8111990221 |
| Fax |
|
| Email |
drdeepthigilla@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Dr Deepthi Gilla |
| Designation |
Associate Professor, Research Officer, Scientist-II, Department of Psychiatry |
| Affiliation |
National Homoeopathy Research Institute in Mental Health |
| Address |
Department of Psychiatry, Room No. 106(4), National Homoeopathy Research Institute in Mental Health, Sachivothamapuram P.O., Kottayam, Kerala-686532
National Homoeopathy Research Institute in Mental Health, Sachivothamapuram P.O., Kottayam, Kerala-686532
Kottayam
KERALA
686532
India |
| Phone |
08111990221 |
| Fax |
|
| Email |
drdeepthigilla@gmail.com |
|
|
Source of Monetary or Material Support
|
| National Homoeopathy Research Institute in Mental Health, Kottayam, Kerala and Peripheral OPD |
|
|
Primary Sponsor
|
| Name |
Dr S Sudheer Kumar |
| Address |
National Homoeopathy Research Institute in Mental Health, Sachivothamapuram, Kottayam, Kerala, 686532 |
| Type of Sponsor |
Other [self] |
|
|
Details of Secondary Sponsor
|
|
|
Countries of Recruitment
|
India |
|
Sites of Study
|
| No of Sites = 1 |
| Name of Principal
Investigator |
Name of Site |
Site Address |
Phone/Fax/Email |
| Dr S Sudheer Kumar |
National Homoeopathy Research Institute in Mental Health |
OPD, IPD, Camps and Peripheral OPDs, National Homoeopathy Research Institute in Mental Health, Sachivothamapuram P.O., Kottayam, Kerala-686532
Kottayam
KERALA |
9746239662
drsudheer1996@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Institutional Ethical Commitee, NHRIMH, Kottayam |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition: F20||Schizophrenia, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Intervention |
Homoeopathic Chlorpromazinum |
After enrollment the cases will be randomized and allocated into two groups viz group A & group B, Homoeopathic Chlorpromazinum will be given to subjects in the study arm in Centesimal potencies starting from 30C, two doses in a month once in 15 days shall be prescribed at each visit. The further selection of Potency will be selected as per the need of the case. The above intervention will be given for a period of 6 months. |
| Comparator Agent |
Homoeopathic Individualized Medicine |
For the cases allocated in group B, the individualized homoeopathic medicine will be administered in control arm starting with 30C potency, two doses in a month once in 15 days shall be prescribed at each visit. The further selection of Potency will be selected as per the need of the case. The above intervention will be given for a period of 6 months. |
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
65.00 Year(s) |
| Gender |
Both |
| Details |
1. Patients of all genders
2. Ages between 18 and 65 years of age
3. Subjects fulfilling ICD 10 diagnostic criteria of Schizophrenia. (F20)
4. Patients under Antipsychotic medication |
|
| ExclusionCriteria |
| Details |
1. Patients with comorbid neuro-psychiatric disorders
2. Patients with serious systemic illness.
3. Pregnant and lactating women |
|
|
Method of Generating Random Sequence
|
Computer generated randomization |
|
Method of Concealment
|
An Open list of random numbers |
|
Blinding/Masking
|
Participant Blinded |
|
Primary Outcome
|
| Outcome |
TimePoints |
| Assessment of reduction in positive symptoms of Schizophrenia using Scale for Assessment of Positive Symptoms, after administration of Homoeopathic Chlorpromazinum and Individualized Homoeopathic Medicine in respective groups. |
Every month from baseline till the conclusion of the study(6th month) |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| Assessment of overall improvement in the symptoms of Schizophrenia using Positive and Negative Syndrome Scale, after administration of Homoeopathic Chlorpromazinum and Individualized Homoeopathic Medicine in respective groups. |
At the baseline and end of the study(6th month) |
| Assessment of reduction in the Side-effects of antipsychotic medications using Glasgow Anti-Psychotics Side-effect Scale after administration of Homoeopathic Chlorpromazinum and Individualized Homoeopathic Medicine in respective groups. |
Baseline, at 3rd,and conclusion of the study(6th month) |
|
|
Target Sample Size
|
Total Sample Size="70"
Sample Size from India="70"
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 2/ Phase 3 |
|
Date of First Enrollment (India)
|
11/01/2024 |
| 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="1"
Months="6"
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
|
The study is a Single Blind Randomized Controlled Trial conducted at the National Homeopathy Research Institute in Mental Health, Kottayam, with a duration of 18 months (12 months enrollment and 6 months follow-up). The primary objective is to compare the effectiveness of homoeopathic Chlorpromazinum with individualized homoeopathic medicine in reducing positive symptoms of schizophrenia. The primary outcome measure is the reduction in positive symptoms assessed by the SAPS (Scale for the Assessment of Positive Symptoms) score. Secondary outcome measures include evaluating the overall symptom reduction with PANSS (Positive and Negative Syndrome Scale) and assessing the effectiveness of homoeopathic medicine in mitigating side effects of antipsychotic medications using the Glasgow Anti-psychotics Side-effect Scale (GASS). Assessments are planned monthly with SAPS, at baseline and study endpoint with PANSS, and every three months with GASS. Monthly follow-ups will be conducted for up to 6 months. |