| CTRI Number |
CTRI/2023/12/060426 [Registered on: 01/12/2023] Trial Registered Prospectively |
| Last Modified On: |
29/11/2023 |
| 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 the effectiveness of homoeopathic medicines for sleeplessness in alcohol dependence |
|
Scientific Title of Study
|
An open label, single arm study on the effectiveness of individualized homoeopathic medicines for Insomnia in Alcohol Dependence |
| 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 Siva Tharshini K R |
| Designation |
Postgraduate Scholar- Department of Psychiatry |
| Affiliation |
National Homoeopathy Research Institute in Mental Health |
| Address |
National Homoeopathy Research Institute in Mental Health, Sachivothamapuram (p.o), Kurichy, Kottayam, Kerala 686532
Kottayam
KERALA
686532
India |
| Phone |
7402369026 |
| Fax |
|
| Email |
sivatharshini97@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr S Karunakara Moorthi |
| Designation |
Professor, Research Officer/Scientist-III, Department of Psychiatry |
| Affiliation |
National Homoeopathy Research Institute in Mental Health |
| Address |
National Homoeopathy Research Institute in Mental Health, Sachivothamapuram (p.o), Kurichy, Kottayam, Kerala 686532
Kottayam
KERALA
686532
India |
| Phone |
8281502571 |
| Fax |
|
| Email |
drjaiguru@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Dr S Karunakara Moorthi |
| Designation |
Professor, Research Officer/Scientist-III, Department of Psychiatry |
| Affiliation |
National Homoeopathy Research Institute in Mental Health |
| Address |
National Homoeopathy Research Institute in Mental Health, Sachivothamapuram (p.o), Kurichy, Kottayam, Kerala 686532
Kottayam
KERALA
686532
India |
| Phone |
8281502571 |
| Fax |
|
| Email |
drjaiguru@gmail.com |
|
|
Source of Monetary or Material Support
|
| Hospital- National Homoeopathy Research Institute in Mental Health, Under Central Council of Research in Homoeopathy, Sachivothamapuram (PO), Kurichy, Kottayam, Kerala-686532 |
|
|
Primary Sponsor
|
| Name |
Dr Siva Tharshini K R |
| Address |
Department of Psychiatry,
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 Siva Tharshini K R |
National Homoeopathy Research Institute in Mental Health |
National Homoeopathy Research Institute in Mental Health, Sachivothamapuram(P.O), Kurichy,
Kottayam, Kerala-686532.
Kottayam
KERALA |
7402369026
sivatharshini97@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Institutional Ethical Committe- National Homoeopathy Research Institute in Mental Health |
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
Medicine |
Totality of symptoms after case taking will be formed. The symptoms are repertorized using RADAR OPUS software and final selection of medicine will be done in consultation with Homoeopathic Materia Medica. The potency, dose and repetition of medicine will be done based on Homoeopathic principles. |
| Comparator Agent |
NIL |
NIL |
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
60.00 Year(s) |
| Gender |
Both |
| Details |
1. Cases fulfilling the diagnostic criteria for alcohol dependence according to ICD 10 Diagnostic criteria.
2. Cases in the age group of 18 to 60 years of both the gender.
3. Score more than or equal to 8 in Insomnia Severity Index.
|
|
| ExclusionCriteria |
| Details |
1. Cases with life threatening conditions.
2. Cases with CIWA- Ar score more than 10.
3. Cases diagnosed with other types of insomnia.
4. Cases already under psychiatric medication for insomnia.
5. Cases with co morbid psychiatric conditions.
6. Pregnant and lactating females.
|
|
|
Method of Generating Random Sequence
|
Not Applicable |
|
Method of Concealment
|
Not Applicable |
|
Blinding/Masking
|
Not Applicable |
|
Primary Outcome
|
| Outcome |
TimePoints |
| Outcome will be measured by changes in Insomnia Severity Index (ISI) every month. |
Every month from baseline till the conclusion of the study (12th month) |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| Outcome will be measured by changes in Severity of Alcohol Dependence Questionnaire (SADQ) every month. |
Every month from baseline till the conclusion of the study (12th month) |
| Outcome will be measured by changes in WHO- QOL BREF scale at baseline and at the end of the study. |
At the baseline and at the end of the study |
|
|
Target Sample Size
|
Total Sample Size="30"
Sample Size from India="30"
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)
|
11/12/2023 |
| 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 is an Open Label, Prospective interventional study to find out the
effectiveness of Individualized Homoeopathic medicines in improving the sleep
of Alcohol Dependence patients. 30 individuals aged 18 to 60, of both sexes who
have symptoms of alcohol dependence (based on ICD- 10 criteria) visiting OPD
and IPD of NHRIMH will be considered based on inclusion criteria. The
enrollment period is for 6 months and the follow up period id for 1 year. The
primary outcome will be assessed by the changes in the Insomnia Severity Index
(ISI) every month. The secondary outcome will be assessed using Severity of Alcohol
Dependence Questionnaire (SADQ) every month and WHO QOL BREF at the baseline
and end of the study. |