| CTRI Number |
CTRI/2023/11/060281 [Registered on: 28/11/2023] Trial Registered Prospectively |
| Last Modified On: |
24/11/2023 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Homeopathy |
| Study Design |
Single Arm Study |
|
Public Title of Study
|
A clinical study on effectiveness of homoeopathy in emotion-regulation of alcoholics |
|
Scientific Title of Study
|
Effectiveness of individualized homoeopathic medicines in reducing the difficulties in emotion-regulation in alcohol dependent individuals |
| 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 Syed Sameer S |
| Designation |
PG Scholar, Department of Psychiatry |
| Affiliation |
National Homoeopathy Research Institute in Mental Health, Kottayam, Kerala |
| Address |
National Homoeopathy Research Institute in Mental Health,
Sachivothamapuram(P.O),
Kurichy
Kottayam
KERALA
686532
India |
| Phone |
9488912968 |
| Fax |
|
| Email |
s.s.sameer1998@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Dhanaraj Kumar Rana |
| Designation |
Research Officer,Scientist-2,Associate Professor, Department of Psychiatry |
| Affiliation |
National Homoeopathy Research Institute in Mental Health, Kottayam, Kerala |
| Address |
National Homoeopathy Research Institute in Mental Health,
Sachivothamapuram(P.O),
Kurichy
Kottayam
KERALA
686532
India |
| Phone |
9496470061 |
| Fax |
|
| Email |
drdkrana123@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Dr Dhanaraj Kumar Rana |
| Designation |
Research Officer,Scientist-2,Associate Professor, Department of Psychiatry |
| Affiliation |
National Homoeopathy Research Institute in Mental Health, Kottayam, Kerala |
| Address |
National Homoeopathy Research Institute in Mental Health,
Sachivothamapuram(P.O),
Kurichy
KERALA
686532
India |
| Phone |
9496470061 |
| Fax |
|
| Email |
drdkrana123@gmail.com |
|
|
Source of Monetary or Material Support
|
| National Homoeopathy Research Institute In Mental Health,
Sachivothamapuram(P.O), Kurichy,
Kottayam, Kerala-686532. |
|
|
Primary Sponsor
|
| Name |
Dr. Syed Sameer S |
| Address |
National Homoeopathy Research Institute in Mental Health,
Sachivothamapuram(P.O),
Kurichy,
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 Syed Sameer S |
National Homoeopathy Research Institute in Mental Health, Kottayam, Kerala |
Substance abuse OPD & IPD, Department of Psychiatry
Kottayam
KERALA |
9488912968
s.s.sameer1998@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: F102||Alcohol dependence, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Intervention |
Individualized homoeopathic medicines |
Totality of symptoms shall be constituted according to Homoeopathic principles after detailed case taking . The symptoms are repertorized using suitable repertory in RADAR OPUS software and final selection of the medicine will be made after consulting Homoeopathic Materia Medica. The indicated remedy will be started in 30C potency and shall be increased till CM potency if required as per the necessity of the case. The dose and repetition of medicine will be done based on Homoeopathic principles. If improvement stops, potency of the medicine will be raised. If no change at all, the case shall be retaken and another appropriate remedy will be prescribed. The prescribed medicines will be dispensed from institutional pharmacy. |
| Comparator Agent |
NIL |
NIL |
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
70.00 Year(s) |
| Gender |
Both |
| Details |
1.Patients in the age group between 18 to 70 years.
2.Cases diagnosed as Alcohol Dependence F10.2 criteria as per ICD-10.
3.Patients with AUDIT score of 13 or more in women, and 15 or more in men.
4.Patients with DERS-SF score of 39 or above. |
|
| ExclusionCriteria |
| Details |
1.Patients with acute alcohol withdrawal and intoxication symptoms.
2.Cases with dependence on other substances.
3.Patients who are currently on psychotropic medications.
4.Patients who currently undergoing any psychotherapies such as CBT and DBT.
5.Cases with serious life-threatening medical conditions.
6.Cases with suicidal ideation
7.Pregnant and lactating women. |
|
|
Method of Generating Random Sequence
|
Not Applicable |
|
Method of Concealment
|
Not Applicable |
|
Blinding/Masking
|
Open Label |
|
Primary Outcome
|
| Outcome |
TimePoints |
| DERS (Difficulties in Emotion Regulation Scale) will be administered in baseline and monthly for 12 months to evaluate the effectiveness of individualized homoeopathic medicines in reducing difficulties in emotion regulation in alcohol-dependent individuals with AUDIT score above 13 in women and above 15 in men and having DERS-SF(DERS-Short Form) total score of 39 or more. The aim is to observe a reduction in the DERS score, indicating an improvement in emotion regulation after giving individualized homoeopathic medicines. |
Every monthly for 12 months ( Baseline and monthly 12 months ) |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| PACS – Penn Alcohol Craving Scale will be administered monthly to evaluate the effectiveness of individualized homoeopathic medicines in reducing alcohol craving in alcohol-dependent individuals. The aim is to observe a reduction in the PACS score, indicating a decrease in alcohol craving |
Baseline and every monthly for 12 months |
| • SADQ - Severity of Alcohol Dependence Questionnaire will be administered every three months to evaluate 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. |
Once in every three months in 12 months ( Baseline, 3rd, 6th, 9th and 12th month ) |
|
|
Target Sample Size
|
Total Sample Size="36"
Sample Size from India="36"
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)
|
04/12/2023 |
| 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 study is an open label single arm clinical interventional study to determine the effectiveness of individualized homoeopathic medicines in reducing the difficulties in emotion-regulation in alcohol dependent individuals, that will be conducted in Psychiatry OPD and IPD of National Homoeopathy Research Institute in Mental Health, Kottayam, Kerala, India. The primary outcome measure will be reduction in Difficulties in Emotion Regulation scale scores, which is to be done at baseline and every monthly for 12 months. The secondary outcomes will be reduction in severity of craving assessed using the Penn Alcohol Craving Scale every monthly and reduction in severity of dependence assessed using the Severity of Alcohol Dependence Questionnaire scale once in three months. This study tries to explore the effectiveness of individualized homoeopathic medicines in reducing the difficulties in emotion-regulation in alcohol dependence individuals.
|