| CTRI Number |
CTRI/2025/06/089334 [Registered on: 23/06/2025] Trial Registered Prospectively |
| Last Modified On: |
20/06/2025 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Homeopathy |
| Study Design |
Single Arm Study |
|
Public Title of Study
|
Reduce the relapse risk in alcohol use disorder |
|
Scientific Title of Study
|
Effectiveness of individualized homoeopathic medicines in reducing relapse risk in patients with alcohol use disorder -a quasi experimental 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 KRISHNA VENI K |
| Designation |
Post graduate scholar,dept of psychiatryN |
| Affiliation |
National homoeopathy research institute in mental health,kottayam,kerala. |
| Address |
Post Graduate Scholar Department of Psychiatry
Room number 8
National Homoeopathy Research Institute in mental health
Post Graduate Scholar Department of Psychiatry
Room number 8
National Homoeopathy Research Institute in mental health
Kottayam
KERALA
686532
India |
| Phone |
9524347426 |
| Fax |
|
| Email |
krishnaveni09032000@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr R Bhuvaneswari |
| Designation |
Professor and head of dept of psychiatry |
| Affiliation |
National homoeopathy research institute in mental health,kottayam,kerala. |
| Address |
Department of psychiatry
Room number 106
National homoeopathy research institute in mental health
Department of psychiatry
Room number 106
National homoeopathy research institute in mental health
Kottayam
KERALA
686532
India |
| Phone |
8281475541 |
| Fax |
|
| Email |
dr.bhuvaneswarir@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Dr R Bhuvaneswari |
| Designation |
Professor and head of dept of psychiatry |
| Affiliation |
National homoeopathy research institute in mental health,kottayam,kerala. |
| Address |
Professor and head of department of psychiatry
Room number 106
National homoeopathy research institute in mental health
Professor and head of department of psychiatry
Room number 106
National homoeopathy research institute in mental health
Kottayam
KERALA
686532
India |
| Phone |
8281475541 |
| Fax |
|
| Email |
dr.bhuvaneswarir@gmail.com |
|
|
Source of Monetary or Material Support
|
| National homoeopathy research institute in mental health,kottyam,kerala |
|
|
Primary Sponsor
|
| Name |
DR KRISHNA VENI K |
| Address |
National homoeopathy research institute in mental health
kurichy,
sachivothamapuram p.o
kottayam-686532
Kerala
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 KRISHNA VENI K |
National homoeopathy research institute in mental health Kottayam. |
Dept of psychiatry
Room number 8
National homoeopathy research institute in mental health Kottayam,Kerala.
Kottayam
KERALA |
95243 47426
Krishnaveni09032000@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,kerala |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition: F10||Alcohol related disorders, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Intervention |
Individualized homoeopathic medicines. |
After enrollment the case will be repertorised. Appropriate
potentized Individualised
Homoeopathic Medicine will be
administered in minimum dose
in appropriate potency according to the need of the
case. Medicine is administered
orally. Repetition will be done when improvement comes to a standstill in a higher potency of the same medicine and if the
medicine is not found to be
effective the case will be
retaken then another appropriate medicine is given.
The above homoeopathic
intervention will be given for a period of one year. |
| Comparator Agent |
Not applicable |
Not applicable |
|
|
Inclusion Criteria
|
| Age From |
19.00 Year(s) |
| Age To |
65.00 Year(s) |
| Gender |
Both |
| Details |
1.Diagnosed cases of alcohol use disorder 303.9 as per DSM V criteria.
2.Participants in both gender age group between 19-65 years.
3.Participants with severity of alcohol dependence questionnaire score above 16.
|
|
| ExclusionCriteria |
| Details |
1.Participants who currently undergoing any psychotherapies such as cognitive behaviour therapy and dialectical behaviour therapy.
2.Non pathological drinker.
3.Participants in the withdrawal period.
4.Cases with serious life-threatening medical conditions.
5.Pregnant and lactating women.
|
|
|
Method of Generating Random Sequence
|
Not Applicable |
|
Method of Concealment
|
Not Applicable |
|
Blinding/Masking
|
Open Label |
|
Primary Outcome
|
| Outcome |
TimePoints |
| ARRS- The Alcohol Relapse Risk Scale will be administered every three months to assess the overall risk of relapse in the study population, with the aim of observing a reduction in the ARRS score, indicating a decreased risk of relapse. |
Every three months from baseline till the conclusion of study. |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
1.ARRS-Alcohol relapse risk scale is administered every three months to identify the most common cause of relapse in alcohol use disorder.
2.SADQ – Severity of Alcohol Dependence Questionnaire will be administered three months to assess the overall severity of alcohol dependence in the study population. The aim is to observe a reduction in the SADQ score, indicating a decrease in the severity of alcohol dependence
By using these outcome measures, the study aims to evaluate the effectiveness of individualized homoeopathic medicines in reducing the risk of relapse (as measured by the ARRS) and the overall severity of alcohol dependence (as measured by the SADQ) in the study population. The desired outcome is a reduction in the scores on these measures, indicating a positive response to the homoeopathic intervention.
|
Every three months from baseline till the conclusion of study. |
|
|
Target Sample Size
|
Total Sample Size="38"
Sample Size from India="38"
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)
|
02/07/2025 |
| 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="8"
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 - YES
- What data in particular will be shared?
Response - All of the individual participant data collected during the trial, after de-identification.
- What additional supporting information will be shared?
Response - Study Protocol
Response - Statistical Analysis Plan
Response - Clinical Study Report
- Who will be able to view these files?
Response - Researchers whose proposed use of the data has been approved by an independent review committee identified for this purpose.
- For what types of analyses will this data be available?
Response - For individual participant data meta-analysis.
- By what mechanism will data be made available?
Response - Proposals should be directed to [Krishnaveni09032000@gmail.com].
- For how long will this data be available start date provided 26-06-2025 and end date provided 11-11-2027?
Response - Immediately following publication. No end date.
- Any URL or additional information regarding plan/policy for sharing IPD?
Additional Information - Nil
|
|
Brief Summary
|
Study aims to assess the effectiveness of individualized homeopathic medicines in reducing relapse risk among individuals with Alcohol Use Disorder (AUD). Employing a quasi-experimental study, the research will be conducted at the IPD, OPD and camp on National Homoeopathy Research Institute in Mental Health, Kottayam, Kerala. Participants, aged 19 to 65 years and diagnosed with AUD as per DSM-5 criteria, will be selected based on a Severity of Alcohol Dependence Questionnaire (SADQ) score above 16. Exclusion criteria include individuals undergoing psychotherapy, non-pathological drinkers, those in withdrawal, those taking medication for other medical conditions, those with serious life-threatening medical conditions, and pregnant or lactating women. The study utilizes the SADQ and Alcohol Relapse Risk Scale (ARRS) to measure alcohol dependence severity and relapse risk at baseline and every three months for 12 months. A minimum of 38 participants will be enrolled, accounting for a 15% dropout rate. Participants will be screened using a verbal questionnaire based on DSM-5 criteria. Individualized homeopathic medicine will be selected based on standard homeopathic guidelines. The primary objective is to determine if individualized homeopathic medicine reduces relapse risk, while secondary objectives include identifying common relapse causes and determining groups of homeopathic medicines are more effective. The study hypothesizes that there will be a significant difference in relapse risk before and after using individualized homeopathic medicines. |