| 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
|
|
|
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
|
|
|
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. |