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CTRI Number  CTRI/2024/09/073432 [Registered on: 05/09/2024] Trial Registered Prospectively
Last Modified On: 04/09/2024
Post Graduate Thesis  Yes 
Type of Trial  Interventional 
Type of Study   Homeopathy 
Study Design  Single Arm Study 
Public Title of Study   Usefulness of Homoeopathic medicines in treating the Substance-Induced Psychotic Disorder 
Scientific Title of Study   Effectiveness of Individualized Homoeopathic Medicines in the management of Substance-Induced Psychotic Disorder – An Open-Label Single-Arm Study 
Trial Acronym  NIL 
Secondary IDs if Any  
Secondary ID  Identifier 
NIL  NIL 
 
Details of Principal Investigator or overall Trial Coordinator (multi-center study)  
Name  Dr M Selvaganapathi 
Designation  Post Graduate Scholar, Department of Psychiatry 
Affiliation  National Homoeopathy Research Institute in Mental Health, Kottayam 
Address  National Homoeopathy Research Institute in Mental Health, Sachivothamapuram (P.O), Kurichy, Kottayam

Kottayam
KERALA
686532
India 
Phone  8667461149  
Fax    
Email  selvaganapathimaddy@gmail.com  
 
Details of Contact Person
Scientific Query
 
Name  Dr M Selvaganapathi 
Designation  Post Graduate Scholar, Department of Psychiatry 
Affiliation  National Homoeopathy Research Institute in Mental Health, Kottayam 
Address  National Homoeopathy Research Institute in Mental Health, Sachivothamapuram (P.O), Kurichy, Kottayam

Kottayam
KERALA
686532
India 
Phone  8667461149  
Fax    
Email  selvaganapathimaddy@gmail.com  
 
Details of Contact Person
Public Query
 
Name  Dr S Karunakaramoorthi 
Designation  Professor, Department of Psychiatry 
Affiliation  National Homoeopathy Research Institute in Mental Health, Kottayam 
Address  National Homoeopathy Research Institute in Mental Health, Sachivothamapuram (P.O), Kurichy, Kottayam

Kottayam
KERALA
686532
India 
Phone  8281502571  
Fax    
Email  drjaiguru@gmail.com  
 
Source of Monetary or Material Support  
National Homoeopathy Research Institute in Mental Health, Sachivothamapuram (P.O), Kurichy, Kottayam, KERALA-686532, India 
 
Primary Sponsor  
Name  Dr M Selvaganapathi 
Address  National Homoeopathy Research Institute in Mental Health, Sachivothamapuram (P.O), Kurichy, Kottayam, KERALA-686532, India 
Type of Sponsor  Other [Self] 
 
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 
Dr M Selvaganapathi  National Homoeopathy Research Institute in Mental Health, Kottayam  OPD, IPD, Camps and Peripheral Units, Department of Psychiatry, National Homoeopathy Research Institute in Mental Health, Sachivothamapuram (P.O), Kurichy, 686532, India
Kottayam
KERALA 
8667461149

selvaganapathimaddy@gmail.com 
 
Details of Ethics Committee  
No of Ethics Committees= 1  
Name of Committee  Approval Status 
Institutional Ethical Committee – National Homoeopathy Research Institute in Mental Health, Kottayam  Approved 
 
Regulatory Clearance Status from DCGI  
Status 
Not Applicable 
 
Health Condition / Problems Studied  
Health Type  Condition 
Patients  (1) ICD-10 Condition: F10-F19||Mental and behavioral disorders due to psychoactive substance use,  
 
Intervention / Comparator Agent  
Type  Name  Details 
Intervention  Individualized Homoeopathic Medicines  Individualized Homoeopathic Medicine potency ranging from 30C to 50M in the form of uniform-sized medicated globules will be administered orally and frequency repetition will be decided according to the severity of symptoms of the participants. Participants will be assessed and given medicine on monthly basis till the conclusion of the study. If there are any adverse reactions or serious adverse events noted after the administration of Homoeopathic Medicines, they will be reported to the institutional Pharmacovigilance department.  
Comparator Agent  Nil  Nil 
 
Inclusion Criteria  
Age From  18.00 Year(s)
Age To  60.00 Year(s)
Gender  Both 
Details  1. Patients of both genders between the ages of 18 to 60.
2. Patients presenting with Psychotic symptoms due to substance use.
3. BPRS score of 18 or more. 
 
ExclusionCriteria 
Details  1. Suicidal ideation.
2. Life-threatening serious systemic illness.
3. Pregnant and lactating women.
4. Primary psychotic disorders.
5. Psychotic disorder due to another medical condition. 
 
Method of Generating Random Sequence   Not Applicable 
Method of Concealment   Not Applicable 
Blinding/Masking   Open Label 
Primary Outcome  
Outcome  TimePoints 
Assessment of the reduction of the severity of symptoms of participants with substance-induced psychotic disorder after the administration of Individualized Homoeopathic Medicines is planned to be done using the Brief Psychiatric Rating Scale (BPRS).  Every month from baseline till the 9th month 
 
Secondary Outcome  
Outcome  TimePoints 
Assessment of the changes in quality of life of participants with substance-induced psychotic disorder after the administration of Individualized Homoeopathic Medicines is planned to be done using the World Health Organization Quality of Life (WHO-BREF-QoL) scale.  At the baseline & at the 9th month 
 
Target Sample Size   Total Sample Size="35"
Sample Size from India="35" 
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 
Date of First Enrollment (India)   17/09/2024 
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 Yet Recruiting 
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  

This open label, single arm, clinical interventional study, aims to investigate whether Individualized Homeopathic Medicine can effectively reduce symptoms associated with substance-induced psychotic disorder (SIPD). SIPD is a condition where individuals experience delusions and hallucinations as a result of substance use. Currently, there is limited research on specific treatments for SIPD, and conventional treatments often focus on managing symptoms rather than addressing the underlying causes. Homeopathy, which takes a holistic approach to health, offers a potential alternative.

The research team plans to enroll 35 participants aged 18 to 60 who have symptoms of SIPD. Participants will undergo detailed screening and assessment to confirm the diagnosis and ensure they meet the study criteria. Those eligible will receive individualized homeopathic treatment based on their unique symptoms, as determined through comprehensive case-taking and analysis.

The severity of participants’ symptoms will be assessed using the Brief Psychiatric Rating Scale (BPRS) at the beginning of the study and regularly throughout the 12-month follow-up period. Additionally, changes in participants’ quality of life will be measured using the World Health Organization Quality of Life (WHOQOL-BREF) scale.

The research team will closely monitor participants’ progress and adjust treatment as needed. Participants who experience adverse reactions or serious events will receive appropriate support and care. To maintain ethical standards, informed consent will be obtained from all participants, and confidentiality will be strictly maintained.

By the end of the study, the researchers aim to determine if Individualized Homeopathic Medicine leads to a significant reduction in SIPD symptoms and improves participants’ quality of life. If successful, this research could provide valuable insights into alternative treatment options for SIPD and potentially reduce the burden of this condition on individuals and society. 
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