| CTRI Number |
CTRI/2025/05/086236 [Registered on: 05/05/2025] Trial Registered Prospectively |
| Last Modified On: |
02/05/2025 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Ayurveda |
| Study Design |
Randomized, Parallel Group, Placebo Controlled Trial |
|
Public Title of Study
|
MANAGEMENT OF ALCOHOL USE DISORDER USING AYURVEDIC FORMULATION (ELADYO MODAK) |
|
Scientific Title of Study
|
study to evaluate the efficacy of eladyo modak in the management of Madatyaya (Alcohol use disorder) |
| Trial Acronym |
nil |
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Roshni Tiwari |
| Designation |
PG scholar |
| Affiliation |
Pt. Khushilal sharma govt ayurveda college, Bhopal |
| Address |
room no 228 Dept of Agad tantra evum vidhi vaidhyak pt khushilal sharma govt ayurveda college bhopal
Bhopal
MADHYA PRADESH
462007
India |
| Phone |
9039134320 |
| Fax |
|
| Email |
roshni996@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
DR URMILA SHUKLA |
| Designation |
PROFESSOR ANDD HOD |
| Affiliation |
Pt. Khushilal sharma govt ayurveda college, Bhopal |
| Address |
PG DEPARTMENT OF AGAD TANTRA EVUM VYAVHAR AYURVEDA ROOM NO 228
PT KHUSHILAL SHARMA GOVT AYURVEDA COLLEGE AND INSTITUTE
Bhopal
MADHYA PRADESH
462007
India |
| Phone |
9039134320 |
| Fax |
|
| Email |
urmila.shukla.393950@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Roshni Tiwari |
| Designation |
PG scholar |
| Affiliation |
Pt. Khushilal sharma govt ayurveda college, Bhopal |
| Address |
room no 228 Dept of Agad tantra evum vidhi vaidhyak pt khushilal sharma govt ayurveda college bhopal
Bhopal
MADHYA PRADESH
462007
India |
| Phone |
9039134320 |
| Fax |
|
| Email |
roshni996@gmail.com |
|
|
Source of Monetary or Material Support
|
| PT KHUSHILAL SHARMA GOVERNMENT AUTONOMOUS AYURVEDA COLLEGE AND INSTITUTE BHOPAL, MADHYA PRADDESH, INDIA 462007 |
|
|
Primary Sponsor
|
| Name |
PT KHUSHILAL SHARMA GOVERNMENT AUTONOMOUS AYURVEDA COLLEGE AND INSTITUTE BHOPAL MP |
| Address |
PT KHUSHILAL SHARMA GOVERNMENT AUTONOMOUS AYURVEDA COLLEGE AND INSTITUTE BHOPAL, MADHYA PRADESH, INDIA 462007 |
| Type of Sponsor |
Government funding agency |
|
|
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 ROSHNI TIWARI |
PT KHUSHILAL SHARMA GOVERNMENT AUTONOMOUS AYURVEDA COLLEGE AND INSTITUTE |
DEPARTMENT OF AGA TANTRA EVUM VIDHI VAIDHYAK, ROOM MO 228 PT KHUSHILAL SHARMA GOVERNMENT AUTONOMOUS AYURVEDA COLLEGE AND INSTITUTE BHOPAL, MADHYA PRADESH,
Bhopal
MADHYA PRADESH |
9039134320
roshni996@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Institutional Ethics Commitee Pt Khushilal Sharma Government Ayurveda Institute Bhopal (MP) |
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: Placebo, Reference: NA, Route: Oral, Dosage Form: Modaka, Dose: 10(g), Frequency: od, Bhaishajya Kal: Abhakta, Duration: 20 Days, anupAna/sahapAna: No, Additional Information: - | | 2 | Intervention Arm | Drug | Classical | | (1) Medicine Name: Eladyo modak, Reference: Bhaishajya ratnavali chapter 22 madatyaya chikitsa prakaran shloka 21-24 , Route: Oral, Dosage Form: Modaka , Dose: 10(g), Frequency: od, Bhaishajya Kal: Abhakta, Duration: 20 Days, anupAna/sahapAna: Yes(details: -milk or mudak yush), Additional Information: - |
|
|
|
Inclusion Criteria
|
| Age From |
20.00 Year(s) |
| Age To |
60.00 Year(s) |
| Gender |
Both |
| Details |
1. Patient of the age group 20-60 years.
2. Patient present with the symptoms of Madatyaya and AUDIT score equal to 8 or above .
3. Patient of either sex will be selected irrespective of caste, creed, religion, occupation, habitat etc.
4. Patient provides informed consent prior to initiation of study procedure and is willing to join the study.
|
|
| ExclusionCriteria |
| Details |
1. Alcohol addicted patients suffering from Liver Cirrhosis, liver cancer, Gastrointestinal bleeding, developed ascites.
2. Alcohol addicted patients who were suffering from major psychiatric disorders or mentally unfit to follow advised treatment.
3. Alcohol addicted patients suffering from major systemic illness like cancer, diabetes, hypertension, myocardial infarction, ischemic heart disease, pulmonary tuberculosis etc.
|
|
|
Method of Generating Random Sequence
|
Other |
|
Method of Concealment
|
Other |
|
Blinding/Masking
|
Participant Blinded |
|
Primary Outcome
|
| Outcome |
TimePoints |
efficacy of Eladyo modak in the management of Madatyaya (AUD).
|
3 weeks |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| It is further expected that this study will be able to provide information related to the safety of the drug in the management of madatyaya & the relief in symptoms of madatyaya. |
11 months |
|
|
Target Sample Size
|
Total Sample Size="40"
Sample Size from India="40"
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)
|
19/05/2025 |
| 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="0"
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
|
The harmful use of alcohol is a component cause of more than 200 disease and injury conditions in individuals, most notably alcohol dependence, liver cirrhosis, cancers and injuries. Drinking alcohol is associated with a risk of developing health problems such as mental and behavioral disorders, including alcohol dependence, and major non communicable diseases such as liver cirrhosis, some cancers and cardiovascular diseases.[1] By understanding the risk factors, patterns of alcohol use, and the impact of alcohol on health, a study is made to establish the effectiveness of Eladyo modak in the management of Madatyaya (AUD). |