| CTRI Number |
CTRI/2025/10/096685 [Registered on: 30/10/2025] Trial Registered Prospectively |
| Last Modified On: |
30/10/2025 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Ayurveda |
| Study Design |
Single Arm Study |
|
Public Title of Study
|
A Study to develop a tool for measuring the severity of Madatyaya (Alcohol Addiction) and to evaluate the benefits of the ayurvedic medicine Ashwagandharishta in managing Madatyaya (Alcohol addiction) |
|
Scientific Title of Study
|
Development and validation of Madatyaya severity assessment tool and a clinical study to evaluate the efficacy of Ashwagandharishta in Madatyaya |
| 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 Maya |
| Designation |
Assistant professor |
| Affiliation |
National institute of ayurveda Jaipur |
| Address |
Room no 208, 2nd Floor, Department of Agad Tantra, NIA Jaipur
Jaipur
RAJASTHAN
302002
India |
| Phone |
7689878486 |
| Fax |
|
| Email |
drmayamahala@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Prof. Anita Sharma |
| Designation |
Professor |
| Affiliation |
National institute of ayurveda Jaipur |
| Address |
Room no 206, 2nd Floor, Department of Agad Tantra, NIA Jaipur
Jaipur
RAJASTHAN
302002
India |
| Phone |
9414078653 |
| Fax |
|
| Email |
anita31sharma@yahoo.com |
|
Details of Contact Person
Public Query
|
| Name |
Dr Maya |
| Designation |
Assistant professor |
| Affiliation |
National institute of ayurveda Jaipur |
| Address |
Room no 208, 2nd Floor, Department of Agad Tantra, NIA Jaipur
Jaipur
RAJASTHAN
302002
India |
| Phone |
7689878486 |
| Fax |
|
| Email |
drmayamahala@gmail.com |
|
|
Source of Monetary or Material Support
|
| National Institute of Ayurveda, Jorawar singh gate, Jaipur (Rajasthan),
Pin code - 302002
Country - India |
|
|
Primary Sponsor
|
| Name |
NIL |
| Address |
NIL |
| Type of Sponsor |
Other [NIL] |
|
|
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 Maya |
Hospital of National Institute of Ayurveda |
Room No 25, Agad Tantra Department
Jaipur
RAJASTHAN |
7689878486
drmayamahala@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Institutional Ethics Committee, National Institute of Ayurveda |
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 | Intervention Arm | Drug | Classical | | (1) Medicine Name: Ashwagandharishta , Reference: Rastantrasaar & Siddhaprayog Sangraha Part – 1st, Route: Oral, Dosage Form: Arishta, Dose: 20(ml), Frequency: bd, Bhaishajya Kal: Adhobhakta, Duration: 30 Days, anupAna/sahapAna: Yes(details: water), Additional Information: - |
|
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
60.00 Year(s) |
| Gender |
Both |
| Details |
Patients currently taking alcohol along with any symptom of Madatyaya mentioned in Brihtrayi, Age between 18-60 years, Patients will be selected randomly, irrespective of gender, economical, educational and marital status, Patients who will give written consent to participate in the clinical trial, Patients with a CIWA-Ar score of less than 30
|
|
| ExclusionCriteria |
|
|
Method of Generating Random Sequence
|
Not Applicable |
|
Method of Concealment
|
Not Applicable |
|
Blinding/Masking
|
Not Applicable |
|
Primary Outcome
|
| Outcome |
TimePoints |
| Changes in Madatyaya severity score post-treatment. |
4 weeks |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| Changes in CIWA score,GGt and other liver parameters |
30 days |
|
|
Target Sample Size
|
Total Sample Size="50"
Sample Size from India="50"
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)
|
20/01/2026 |
| 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="6"
Days="3" |
|
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
|
it is a study on the patients of Madatyaya (alcohol addiction) Ashwagandharishta which is a classical drug, will be given to the enrolled patients and after 30 days the difference in Madatyaya Severity Assessment Tool score will be observed. We have to assess the difference in MSAT score (before and after treatment) |