| CTRI Number |
CTRI/2025/03/083221 [Registered on: 24/03/2025] Trial Registered Prospectively |
| Last Modified On: |
20/03/2025 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Drug
Ayurveda |
| Study Design |
Randomized, Parallel Group Trial |
|
Public Title of Study
|
To Study The Efficacy Of Rohitakadya Churna And Pathya Ghrut In Madatyaya W.S.R.To Alcohol Induced Hepatotoxicity. |
|
Scientific Title of Study
|
A Comparative Study The Efficacy Of Rohitakadya Churna And Pathya Ghrut In Madatyaya With Special Reference To Alcohol Induced Hepatotoxicity |
| Trial Acronym |
|
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Dr Shraddha Sandip Yadav |
| Designation |
PG Scholar MD Agadatantra |
| Affiliation |
LRP Ayurvedic Medical College hospital PG institute and research centre urun islampur |
| Address |
Department of Agadatantra LRP Ayurvedic Medical College hospital PG institute and research centre urun islampur
Sangli
MAHARASHTRA
415409
India |
| Phone |
7756008760 |
| Fax |
|
| Email |
shraddhayadav2802@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Ashwini Abhinandan Patil |
| Designation |
HOD and Professor of Agadatantra |
| Affiliation |
LRP Ayurvedic Medical College hospital PG institute and research centre urun islampur |
| Address |
Department of Agadatantra LRP Ayurvedic Medical College hospital PG institute and research centre urun islampur
Sangli
MAHARASHTRA
415409
India |
| Phone |
9822735373 |
| Fax |
|
| Email |
drashwiniapatil@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Dr Ashwini Abhinandan Patil |
| Designation |
HOD and Professor of Agadatantra |
| Affiliation |
LRP Ayurvedic Medical College hospital PG institute and research centre urun islampur |
| Address |
Department of Agadatantra LRP Ayurvedic Medical College hospital PG institute and research centre urun islampur
MAHARASHTRA
415409
India |
| Phone |
9822735373 |
| Fax |
|
| Email |
drashwiniapatil@gmail.com |
|
|
Source of Monetary or Material Support
|
| LRP Ayurvedic medical College hospital pg institute and research centre urun islampur Tal walwa Dist Sangli Maharashtra 415409 |
|
|
Primary Sponsor
|
| Name |
LRP Ayurvedic Hospital and Research centre |
| Address |
LRP Ayurvedic medical college hospital pg institute and research centre urun islampur |
| 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 Ashwini Abhinandan Patil |
LRP Ayurvedic Medical College and Hospital PG Institute Research centre |
Department Of Agadatantra LRP Ayurvedic Medical College and Hospital PG Institute Research Centre Islampur Tal Walwa 415409
Sangli
MAHARASHTRA |
7756008760
drashwiniapatil@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Institutional Ethics Committe Of Loknete Rajarambapu Patil Ayurvedic Medical College and Hospital, Post Graduate Institute and Research Centre Urun Islampur Tal.Walwa Dist. Sangli Maharashtra 415409 |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition:K709||Alcoholic liver disease, unspecified. Ayurveda Condition: MADATYAYAH/PANATYAYAH, |
|
|
Intervention / Comparator Agent
|
| sno | Intervention/Comparator | Type | Drug-Type | Procedure Name | Details | | 1 | Comparator Arm | Drug | Classical | | (1) Medicine Name: Pathya Ghrut, Reference: Chakradata /Madatyaya 16, Route: Oral, Dosage Form: Ghrita, Dose: 10(ml), Frequency: bd, Bhaishajya Kal: Sabhakta, Duration: 45 Days, anupAna/sahapAna: Yes(details: -Koshna Jala), Additional Information: - | | 2 | Intervention Arm | Drug | Classical | | (1) Medicine Name: Rohitakadya Churna , Reference: Bhaishajya Ratnavali 41/10-11, Route: Oral, Dosage Form: Churna/ Powder, Dose: 1(g), Frequency: bd, Bhaishajya Kal: Adhobhakta, Duration: 45 Days, anupAna/sahapAna: Yes(details: -Koshna Jala), Additional Information: - |
|
|
|
Inclusion Criteria
|
| Age From |
25.00 Year(s) |
| Age To |
50.00 Year(s) |
| Gender |
Male |
| Details |
1 Only male patients given.
2 Patient between age group of 25 to 50 year.
3 Derenged liver function test.
4 Patients taking madya regularly. |
|
| ExclusionCriteria |
| Details |
1 Female patients are excluded.
2 Age below 25 yr and more than 50 year as no.of this category was excluded.
3 Drug addicts rapid deterioration who lapsed into coma and bleeding tendencies.
4 Hypertensive patients
5 Patients with high risk diseases.
EG . IHD CRF
|
|
|
Method of Generating Random Sequence
|
Computer generated randomization |
|
Method of Concealment
|
Not Applicable |
|
Blinding/Masking
|
Not Applicable |
|
Primary Outcome
|
| Outcome |
TimePoints |
| To comparative study the efficacy of Rohitakadya churna and Pathya ghrut in Madatyaya w.s.r.to known patients of alcohol induced hepatotoxicity. |
45 days |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| To evaluate the effect of Rohitakadya Churna and Pathya Ghrut in know patients of alcohol induced hepatotoxicity. |
45 days |
|
|
Target Sample Size
|
Total Sample Size="60"
Sample Size from India="60"
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)
|
01/10/2025 |
| 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="6"
Days="10" |
|
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
|
In madataya yakrut and pleeha dushtivikar occurs. One of the drug pathya ghrut is used samanya lakshana of madatyaya from chakradatta .Reference from Bhaishajya Ratnawali pleeha yakrut rog chikitsa prakaranam .Chief ingredients in this formulations acts on pitta and in alcoholic liver disorders. Rohitaka is having pleehaghna prabhav, Rohitak is drug of choice on yarut vikar . Pathya ghrut as wall as rohitakadya churna effect on alcoholic liver disorders. subjective and objective parameters will check and analyse before and after treatment . Total duration of treatment is 45 days. |