| CTRI Number |
CTRI/2025/01/079378 [Registered on: 24/01/2025] Trial Registered Prospectively |
| Last Modified On: |
24/01/2025 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Drug
Ayurveda
Preventive
Behavioral |
| Study Design |
Non-randomized, Active Controlled Trial |
|
Public Title of Study
|
A Study to Evaluate the Effectiveness of BooZNil in Helping Individuals with Alcohol Dependence |
|
Scientific Title of Study
|
Effectiveness of BooZNil in the Management of Alcohol Dependence: A Prospective Non-Randomized Clinical 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 |
Priyadharshini Ananthathandavan |
| Designation |
Assistant Profesor |
| Affiliation |
SRM College of Pharmacy SRMIST |
| Address |
J 02 4TH FLOOR
DEPARTMENT OF PHARMACY PRACTICE
SRM MEDICAL COLLEGE HOSPITAL AND RESEARCH CENTRE
KATTANKULATHUR
01 GROUND FLOOR
SRM COLLEGE OF PHARMACY
SRMIST KTR
Chennai
TAMIL NADU
603203
India |
| Phone |
09787402050 |
| Fax |
|
| Email |
priyathandavan93@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Vijayakumar TM |
| Designation |
Professor |
| Affiliation |
SRM College of Pharmacy SRMIST |
| Address |
J01 4TH FLOOR Department of Pharmacy Practice
SRM Medical College Hospital and Research Centre
SRMIST KATTANKULATHUR CHENGALPATTU TAMIL NADU-603203
Chennai
TAMIL NADU
603203
India |
| Phone |
9003400350 |
| Fax |
|
| Email |
vijaypractice@yahoo.com |
|
Details of Contact Person
Public Query
|
| Name |
Vijayakumar TM |
| Designation |
Professor |
| Affiliation |
SRM College of Pharmacy SRMIST |
| Address |
J01 4TH FLOOR Department of Pharmacy Practice
SRM Medical College Hospital and Research Centre
SRMIST KATTANKULATHUR CHENGALPATTU TAMIL NADU-603203
Chennai
TAMIL NADU
603203
India |
| Phone |
9003400350 |
| Fax |
|
| Email |
vijaypractice@yahoo.com |
|
|
Source of Monetary or Material Support
|
| MMC Pharmaceuticals Pvt Ltd
113 Visalakshi Street
Devi Karumariamman Nagar Valasaravakkam
Chennai
Tamil Nadu
600087
India |
|
|
Primary Sponsor
|
| Name |
MMC PHARMACEUTICALS LTD |
| Address |
MMC Pharmaceuticals Pvt Ltd
113, Visalakshi Street
Devi Karumariamman Nagar Valasaravakkam
Chennai
Tamil Nadu
600087
India |
| Type of Sponsor |
Pharmaceutical industry-Indian |
|
|
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 |
| PRIYADHARSHINI A |
SRM MEDICAL COLLEGE HOSPITAL AND RESEARCH CENTRE |
DEPARTMENT OF COMMUNITY MEDICINE
SRM MRDICAL COLLEGE HOSPITAL AND RESEARCH CENTRE
SRMIST KATTANKULATHUR
CHENGALPATTU 603203 TAMIL NADU INDIA
Chennai
TAMIL NADU |
9787402050
priyathandavan93@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| SRM MEDICAL COLLEGE HOSPITAL AND RESEARCH CENTRE KATTANKULATHUR 603203 CHENGALPATTU TAMILNADU INDIA |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition:F102||Alcohol dependence. Ayurveda Condition: MADATYAYAH/PANATYAYAH, |
|
|
Intervention / Comparator Agent
|
| sno | Intervention/Comparator | Type | Drug-Type | Procedure Name | Details | | 1 | Comparator Arm | Drug | Other than Classical | | (1) Medicine Name: BoozNil, Reference: NA, Route: Oral, Dosage Form: Sharkara/ Syrup, Dose: 10(ml), Frequency: bd, Bhaishajya Kal: Adhobhakta, Duration: 3 Months, anupAna/sahapAna: Yes(details: -), Additional Information: - |
|
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
70.00 Year(s) |
| Gender |
Male |
| Details |
Participants willing to be abstinent from alcohol for at least 5 days before entry into the study.
Participants expected to have good social support or a family environment to ensure treatment compliance and follow-up
Diagnosis as per ICD-10 criteria for alcohol dependence.
Clinical institute withdrawal assessment for alcohol revised (CIWA-ar) score less than 10
Participants willing to give informed consent.
|
|
| ExclusionCriteria |
| Details |
Participants with cirrhosis of the liver.
Participants with Liver function test (LFT) values more than three times the normal values
Will be excluded from the study.
Participants with any chronic systemic illness or with life-threatening disease.
Participants with other substance abuse/addiction.
Participants with any co-morbid psychiatric disorder |
|
|
Method of Generating Random Sequence
|
Not Applicable |
|
Method of Concealment
|
Not Applicable |
|
Blinding/Masking
|
Open Label |
|
Primary Outcome
|
| Outcome |
TimePoints |
To observe and document Drinking Behavior assessment - abstinence rate of study subjects over 30th ,60th ,90th day of BooZNil.
To assess the Percentage (%) of study subjects with complete abstinence of alcohol consumption over treatment period of 12 weeks and Cumulative abstinence duration (defined as the number of days of abstinence during the treatment period).
To estimate serum carbohydrate deficient transferrin over baseline and 30th ,60th and 90th day of therapy.
To evaluate the effect of BooZNil in the liver function tests from baseline to 30th, 60th and 90th day of follow up. |
Baseline, 30th, 60th and 90th day of follow up. |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
To assess scores of cravings as rated by Alcohol Craving Questionnaire (ACQ) and Obsessive-Compulsive Drinking Scale (OCDS) from baseline to 30th, 60th and 90th day of BooZNilTM treatment.
To observe and assess any withdrawal symptoms and adverse events during study period.
|
Baseline, 30th, 60th and 90th day of follow up. |
|
|
Target Sample Size
|
Total Sample Size="30"
Sample Size from India="30"
Final Enrollment numbers achieved (Total)= "30"
Final Enrollment numbers achieved (India)="30" |
|
Phase of Trial
|
N/A |
|
Date of First Enrollment (India)
|
17/02/2025 |
| Date of Study Completion (India) |
05/09/2025 |
| Date of First Enrollment (Global) |
Date Missing |
| Date of Study Completion (Global) |
Date Missing |
|
Estimated Duration of Trial
|
Years="0"
Months="6"
Days="30" |
|
Recruitment Status of Trial (Global)
|
Not Yet Recruiting |
| Recruitment Status of Trial (India) |
Completed |
|
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
|
Effectiveness of BooZNil in Managing Alcohol Dependence Study Design A single arm, open label, prospective clinical trial conducted over six months. Primary Objective
To evaluate the effectiveness of BooZNil in achieving and maintaining abstinence in alcohol-dependent individuals over 12 weeks by assessing: Abstinence rates Changes in serum carbohydrate-deficient transferrin (CDT) levels Improvement in liver function test parameters Secondary Objectives Evaluate reductions in alcohol cravings using Alcohol Craving Questionnaire (ACQ) and Obsessive Compulsive Drinking Scale (OCDS) Assess the safety and tolerability of BooZNil™ by monitoring adverse events and withdrawal symptoms Sample Size 30 male participants aged 18 to70 years diagnosed with alcohol dependence as per ICD10 criteria. Intervention BooZNil syrup (herbal formulation) administered over 12 weeks. Inclusion Criteria Diagnosed with alcohol dependence (ICD-10 criteria) Abstinent for at least 5 days before recruitment CIWA-ar score <10 Exclusion Criteria Severe comorbid conditions Concurrent use of psychotropic medications History of significant adverse reaction to herbal formulations Outcome Measures Primary: Abstinence rate, CDT levels, liver function improvement Secondary: Reduction in craving scores, adverse event monitoring funded by MMC Pharmaceuticals, Chennai Trial Duration 6 months Ethical Approval Obtained from the Institutional Ethics Committee.
|