| CTRI Number |
CTRI/2023/10/059212 [Registered on: 27/10/2023] Trial Registered Prospectively |
| Last Modified On: |
21/04/2025 |
| Post Graduate Thesis |
No |
| Type of Trial |
Interventional |
|
Type of Study
|
Homeopathy |
| Study Design |
Randomized, Parallel Group, Active Controlled Trial |
|
Public Title of Study
|
Quercus Robur in Reducing the Craving for Alcohol. |
|
Scientific Title of Study
|
A Pilot, Double-Blinded, Randomized Controlled Trial to Assess the Effectiveness of Quercus Robur Glandium Spiritus Versus Individualized Homoeopathic Medicine in Reducing the Craving for Alcohol. |
| 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 Deepthi Gilla |
| Designation |
Research officer/Scientist-2, |
| Affiliation |
National Homoeopathy Research Institute in Mental Health, Kottayam. |
| Address |
Dept. of Psychiatry,
National Homoeopathy Research Institute in Mental Health, Kottayam, Kerala.
Kottayam
KERALA
686532
India |
| Phone |
8111990221 |
| Fax |
|
| Email |
drdeepthigilla@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Deepthi Gilla |
| Designation |
Research officer/Scientist-2, |
| Affiliation |
National Homoeopathy Research Institute in Mental Health, Kottayam. |
| Address |
Dept. of Psychiatry,
National Homoeopathy Research Institute in Mental Health, Kottayam, Kerala.
Kottayam
KERALA
686532
India |
| Phone |
8111990221 |
| Fax |
|
| Email |
drdeepthigilla@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Dr Deepthi Gilla |
| Designation |
Research officer/Scientist-2, |
| Affiliation |
National Homoeopathy Research Institute in Mental Health, Kottayam. |
| Address |
Dept. of Psychiatry,
National Homoeopathy Research Institute in Mental Health, Kottayam, Kerala.
Kottayam
KERALA
686532
India |
| Phone |
8111990221 |
| Fax |
|
| Email |
drdeepthigilla@gmail.com |
|
|
Source of Monetary or Material Support
|
|
National Homoeopathy Research Institute in Mental Health, Kottayam.
|
|
|
Primary Sponsor
|
| Name |
National Homoeopathy Research Institute in Mental Health, Kottayam. |
| Address |
Kurichy, Kottayam, Kerl. |
| Type of Sponsor |
Research institution and hospital |
|
|
Details of Secondary Sponsor
|
|
|
Countries of Recruitment
|
India |
Sites of Study
Modification(s)
|
| No of Sites = 1 |
| Name of Principal
Investigator |
Name of Site |
Site Address |
Phone/Fax/Email |
| Dr Deepthi Gilla |
Regional Research Institute (H), Hyderabad |
Room no.09
Hyderabad
TELANGANA |
8111990221
drdeepthigilla@gmail.com |
|
Details of Ethics Committee
Modification(s)
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| IEC, RRI(H), Hyderabad |
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 |
| Comparator Agent |
Individualized Homoeopathic Medicine |
Homoeopathic Medicine selected on the basis of the principle of individualization in Homeopathy in ascending centesimal potencies for 2 months. |
| Intervention |
Quercus Robur Glandium Spiritus |
Specific Homeopathic remedy, Quercus robur has a clinical effect in reducing craving for alcohol in patients with Alcohol Dependence syndrome |
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
60.00 Year(s) |
| Gender |
Both |
| Details |
1. Fulfilling ICD-10 diagnostic criteria for Alcohol dependence
2. Patients willing to quit alcohol
3. Written informed consent
|
|
| ExclusionCriteria |
| Details |
1. Patients with severe systemic illness
2. Cases with other substance abuse
3. With co-morbid severe psychiatric illness
4. Patients who had previously suffered severe withdrawal symptoms
5. Pregnant women and lactating mothers
|
|
|
Method of Generating Random Sequence
|
Computer generated randomization |
|
Method of Concealment
|
Pharmacy-controlled Randomization |
|
Blinding/Masking
|
Participant and Investigator Blinded |
|
Primary Outcome
|
| Outcome |
TimePoints |
| Penn Alcohol craving Scale (PACS) |
0,1,2,3,4,8 weeks |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| Severity of Alcohol Dependence Scale-SADQ |
0,1,2 MONTHS |
|
|
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/ Phase 3 |
|
Date of First Enrollment (India)
|
04/11/2023 |
| 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="0"
Months="6"
Days="0" |
|
Recruitment Status of Trial (Global)
|
Not Yet Recruiting |
| Recruitment Status of Trial (India) |
Open to Recruitment |
Publication Details
Modification(s)
|
N/A |
|
Individual Participant Data (IPD) Sharing Statement
|
Will individual participant data (IPD) be shared publicly (including data dictionaries)?
Response - NO
|
Brief Summary
Modification(s)
|
| Title | A Pilot, Double-Blinded, Randomized Controlled Trial to Assess the Effectiveness of Quercus Robur Glandium Spiritus Vs Individualized Homoeopathic Medicine in Reducing the Craving for Alcohol. | | Short title | Quercus Robur in Alcohol Dependence- A pilot study. | | Protocol number | 2.4 | | Study design | Two-armed, Parallel Group Randomized Controlled Trial. | | Study duration | 6 months (Pre-trial preparations-1 month+ 2months for enrolment +2 months for follow up+ 1 month for compilation) | | Study centre(s) | Regional Research Institute(H), Hyderabad | | Objective (s) | To assess the effectiveness of Quercus Robur Glandium Spiritus compared to Individualized Homoeopathy in reducing the Craving for alcohol in Alcohol Dependence Syndrome patients. | | Number of subjects | 30 subjects (15 for each arm) would be selected from OPD and IPD of NHRIMH, Kottayam. | | Diagnosis and main inclusion criteria | Diagnosis shall be made according to ICD-10 criteria. Subjects of ages 18 to 60 years from various occupations and socio-economic conditions suffering from ADS, willing to quit alcohol. | | Study product, Dose, regimen | Dynamic medicinal preparation of Quercus robur and Individualized Homoeopathic medicine in centesimal scale will be given as per the principles of Homoeopathy shall be administered orally in pills form | | Statistical methodology | Student’s t-test, and any other appropriate statistical tests as applicable by using SPSS software, version-20.0/ Statscraft software | | Proposed tools/ scales for the study | Screening-AUDIT, CIWA-Ar; Severity assessment-SADQ, PACS | |