| CTRI Number |
CTRI/2026/01/100554 [Registered on: 08/01/2026] Trial Registered Prospectively |
| Last Modified On: |
07/01/2026 |
| Post Graduate Thesis |
No |
| Type of Trial |
Interventional |
|
Type of Study
|
Other (Specify) [Community Based Health Care] |
| Study Design |
Cluster Randomized Trial |
|
Public Title of Study
|
A study done in community setup among women consuming alcohol to help them reduce the intake of alcohol and improve their family relationship and build their confidence. |
|
Scientific Title of Study
|
Effectiveness of a Community-Based Multimodal Intervention (CBMI) on alcohol use, self-esteem, family functioning and abstinence motive among women using alcohol in selected villages of Sikkim-A cluster randomized controlled trial |
| Trial Acronym |
NIL |
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Pranita Sharma |
| Designation |
PhD Scholar |
| Affiliation |
Manipal Academy of Higher Education |
| Address |
Manipal College of Nursing Madhav Nagar UDUPI Karnataka India
Manipal College of Nursing Madhav Nagar UDUPI Karnataka India
Udupi
KARNATAKA
576104
India |
| Phone |
08972184542 |
| Fax |
|
| Email |
pranita.s@smcon.smu.edu.in |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Binil V |
| Designation |
Additional Professor & HOD |
| Affiliation |
Manipal College of Nursing |
| Address |
Manipal College of Nursing Madhav Nagar UDUPI Karnataka India
Udupi
KARNATAKA
576104
India |
| Phone |
9844387432 |
| Fax |
|
| Email |
vp.binil@manipal.edu |
|
Details of Contact Person
Public Query
|
| Name |
Pranita sharma |
| Designation |
PhD Scholar |
| Affiliation |
Manipal Academy Of Higher Education |
| Address |
Manipal College of Nursing Madhav Nagar UDUPI Karnataka India
Udupi
KARNATAKA
576104
India |
| Phone |
08972184542 |
| Fax |
|
| Email |
pranita.s@smcon.smu.edu.in |
|
|
Source of Monetary or Material Support
|
| Tumlabong PHSc, Under Martam BAC, Gangtok District Sikkim, 737102 |
|
|
Primary Sponsor
|
| Name |
Pranita Sharma |
| Address |
Manipal College of Nursing, MAHE, Madhav Nagar,UDUPI,Karnataka, 576104 |
| Type of Sponsor |
Other [self ] |
|
|
Details of Secondary Sponsor
|
| Name |
Address |
| Pranita Sharma |
Manipal College of Nursing, MAHE, Madhav Nagar,UDUPI,Karnataka |
|
|
Countries of Recruitment
|
India |
|
Sites of Study
|
| No of Sites = 1 |
| Name of Principal
Investigator |
Name of Site |
Site Address |
Phone/Fax/Email |
| Dr Rubi Dey |
Tumlabong PHSc |
Namli GPU Under Martam BAC, Waiting room No.002, Gangtok District Sikkim
East
SIKKIM |
9434709969
rubi.d@smims.smu.edu.in |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| SMIMSINSTITUTIONETHICSCOMITTE |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Healthy Human Volunteers |
Women Alcoholics |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Intervention |
CBMI Community Based Multimodal Intervention |
CBMI is delivered over a period of 6 weeks to the women study participant and a selected family member of the women participant |
| Comparator Agent |
Not Applicable |
Not Applicable |
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
49.00 Year(s) |
| Gender |
Female |
| Details |
Both married and single
Able to read, write, and comprehend in either English, Nepali or Hindi language
|
|
| ExclusionCriteria |
| Details |
Already on de-addiction treatment.
Diagnosed with mental illness and under treatment
Terminally ill women
|
|
|
Method of Generating Random Sequence
|
Stratified randomization |
|
Method of Concealment
|
Other |
|
Blinding/Masking
|
Open Label |
|
Primary Outcome
|
| Outcome |
TimePoints |
Reduction in alcohol use (AUDIT score change)
|
1st 3rd and 6th month |
|
|
Secondary Outcome
|
|
|
Target Sample Size
|
Total Sample Size="522"
Sample Size from India="522"
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)
|
30/10/2026 |
| 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="2"
Months="0"
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 - NO
|
|
Brief Summary
|
Community-Based Multimodal Intervention is a comprehensive package of strategies
developed by the investigator for the women based on alcohol use, comprising of
a module of 15 hours delivered over 6 weeks period, with strategies focusing on
alcohol use reduction strategies, self-esteem building, improving family
functioning and improvement in abstinence motive for the study participant and
the nominated family member of the study participant. |