| CTRI Number |
CTRI/2025/07/090986 [Registered on: 16/07/2025] Trial Registered Prospectively |
| Last Modified On: |
14/07/2025 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Ayurveda |
| Study Design |
Randomized, Parallel Group, Active Controlled Trial |
|
Public Title of Study
|
comparative Treatment of Alcoholism with Shreekhanda Sava and Eladi Modak in Random patient. |
|
Scientific Title of Study
|
Assessment and Comparison of Shreekhanda Sava and Eladi Modak in the Treatment of Madatyaya: A Randomized Controlled Study |
| 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 Deabasish Satpathy |
| Designation |
Associate professor |
| Affiliation |
|
| Address |
Dept. of Agadatantra, Sri Sri College of Ayurvedic science and research hospital, Sri Sri university,
Cuttack
ORISSA
754006
India |
| Phone |
9437865461 |
| Fax |
|
| Email |
debasishsaptathy10@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr. Debasish Satpathy |
| Designation |
Associate professor |
| Affiliation |
|
| Address |
Dept. of Agadtantra, Sri Sri College of Ayurvedic science and research hospital, Sri Sri university,
Dhenkanal
ORISSA
754006
India |
| Phone |
9437865461 |
| Fax |
|
| Email |
debasishsatpathy10@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Dr Pradip Kumar Panda |
| Designation |
Professor |
| Affiliation |
|
| Address |
Dept. of Roganidan, Sri Sri College of Ayurvedic science and research hospital, Sri Sri university,
Cuttack
ORISSA
754006
India |
| Phone |
9777868699 |
| Fax |
|
| Email |
pradip.p@srisriuniversity.edu.in |
|
|
Source of Monetary or Material Support
|
|
|
Primary Sponsor
|
| Name |
Dr Debasish Satpathy |
| Address |
Dept. of Agadatantra, Sri Sri College of Ayurvedic science and research hospital, Sri Sri university. |
| Type of Sponsor |
Research institution and hospital |
|
|
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 Deabasish Satpathy |
Sri Sri College of Ayurvedic science and research hospital |
Ward no 3, vidyadharpur
Cuttack
ORISSA |
9437865461
debasishsaptathy10@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Institutional ethics comitte for biomedical research of faculty of health and wellness |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition:F439||Reaction to severe stress, unspecified. Ayurveda Condition: MADATYAYAH/PANATYAYAH, |
|
|
Intervention / Comparator Agent
|
| sno | Intervention/Comparator | Type | Drug-Type | Procedure Name | Details | | 1 | Intervention Arm | Drug | Classical | | (1) Medicine Name: shrikhand asava, Reference: bhaisajya ratnavali, Route: Oral, Dosage Form: Asava, Dose: 20(ml), Frequency: bd, Bhaishajya Kal: Adhobhakta, Duration: 3 Months, anupAna/sahapAna: Yes(details: -water), Additional Information: - | | 2 | Comparator Arm | Drug | Classical | | (1) Medicine Name: eladi modak, Reference: bhaisajya ratnavali, Route: Oral, Dosage Form: Modaka , Dose: 10(g), Frequency: bd, Bhaishajya Kal: Adhobhakta, Duration: 3 Months, 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 aged 18-60 years.
• Diagnosed with chronic alcoholism based on DSM-5 criteria.
• Willingness to participate and provide informed consent.
|
|
| ExclusionCriteria |
| Details |
Patients with severe comorbid medical conditions.
Pregnant or lactating women.
patients currently undergoing other forms of addiction treatment
|
|
|
Method of Generating Random Sequence
|
Computer generated randomization |
|
Method of Concealment
|
An Open list of random numbers |
|
Blinding/Masking
|
Double Blind Double Dummy |
|
Primary Outcome
|
| Outcome |
TimePoints |
• Reduction in alcohol consumption and cravings.
• Improvement in liver function tests.
• Decrease in withdrawal symptoms.
|
3 months |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| Enhancement in psychological well-being and quality of life. |
3 months |
|
|
Target Sample Size
|
Total Sample Size="100"
Sample Size from India="100"
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
|
N/A |
|
Date of First Enrollment (India)
|
01/09/2025 |
| 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="2"
Months="6"
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
|
Madatyaya,
known as chronic alcoholism, is a severe condition resulting from prolonged
excessive consumption of alcohol. It leads to various physical and
psychological health issues, including liver damage, neurological disorders,
and social problems. Traditional Ayurvedic medicine offers therapeutic
interventions like Shreekhanda Sava and Eladi Modak, which have shown potential
benefits in managing alcohol dependency. This study aims to evaluate and
compare the efficacy of these Ayurvedic formulations in treating patients
diagnosed with Madatyaya. |