| CTRI Number |
CTRI/2025/11/097833 [Registered on: 21/11/2025] Trial Registered Prospectively |
| Last Modified On: |
20/11/2025 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Ayurveda |
| Study Design |
Randomized, Parallel Group Trial |
|
Public Title of Study
|
A Study To Comapre the Effects of Two Ayurvedic Medicine, Srikhandasava And Patolakaturohinyadi Kashaya, In adults with Alcoholic Fatty Liver Grade II for improving Liver health and Reducing Liver Fat. |
|
Scientific Title of Study
|
A Randomized, Controlled, Open-Label, Clinical Study To Evaluate The Efficacy Of Srikhandasava And Patolakaturohinyadi Kashaya In The Management Of Alcoholic Fatty Liver Grade II |
| 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 Sunil Kumar |
| Designation |
Ph.D Scholar |
| Affiliation |
Shri Krishna Ayush University |
| Address |
Room No 69
Block 1
Department of Agad Tantra
Shri Krishna Ayush University
Umri Road
Sector 8
Kurukshetra
Kurukshetra
HARYANA
136118
India |
| Phone |
9569023573 |
| Fax |
|
| Email |
sunilbams20@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Brijender Singh Tomar |
| Designation |
HOD and Professor |
| Affiliation |
Institute for Ayurved Studies and Research (Faculty of Ayurved) |
| Address |
Room No 69
Block 1
Department of Agad Tantra
Shri Krishna Ayush University
Umri Road
Sector 8
Kurukshetra
Kurukshetra
HARYANA
136118
India |
| Phone |
8950264121 |
| Fax |
|
| Email |
drbs_tomar@yahoo.co.in |
|
Details of Contact Person
Public Query
|
| Name |
Dr Sunil Kumar |
| Designation |
Ph.D Scholar |
| Affiliation |
Shri Krishna Ayush University |
| Address |
Room No 69
Block 1
Department of Agad Tantra
Shri Krishna Ayush University
Umri Road
Sector 8
Kurukshetra
Kurukshetra
HARYANA
136118
India |
| Phone |
9569023573 |
| Fax |
|
| Email |
sunilbams20@gmail.com |
|
|
Source of Monetary or Material Support
|
| National College of Ayurveda and Hospital, Dhani Garan Road, Barwala, Hisar, Haryana 125121 |
|
|
Primary Sponsor
|
| Name |
Dr Sunil Kumar |
| Address |
Room No 69
Block 1
Department of Agad Tantra
Shri Krishna Ayush University
Umri Road
Sector 8
Kurukshetra |
| Type of Sponsor |
Other [Self] |
|
|
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 Sunil Kumar |
National College of Ayurveda and Hopsital |
Department of Agad Tantra,
National College of Ayurveda and Hospital, Dhani Garan Road, Barwala
Hisar
HARYANA |
9569023573
sunilbams20@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| SKAU KURUKSHETRA IEC |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition:K700||Alcoholic fatty liver. Ayurveda Condition: YAKRUDDALYUDARAH, |
|
|
Intervention / Comparator Agent
|
| sno | Intervention/Comparator | Type | Drug-Type | Procedure Name | Details | | 1 | Intervention Arm | Drug | Classical | | (1) Medicine Name: SRIKHANDASAVA, Reference: Bhaishajya Ratnavali Chapter 22, Route: Oral, Dosage Form: Asava, Dose: 24(ml), Frequency: bd, Bhaishajya Kal: Adhobhakta, Duration: 2 Months, anupAna/sahapAna: No, Additional Information: - | | 2 | Comparator Arm | Drug | Classical | | (1) Medicine Name: PATOLAKATUROHINYADI KASHAYA, Reference: ASHTANGA HRIDAYA Chapter 15, Route: Oral, Dosage Form: Kwatha/ Kashaya, Dose: 24(ml), Frequency: bd, Bhaishajya Kal: Adhobhakta, Duration: 2 Months, anupAna/sahapAna: No, Additional Information: - |
|
|
|
Inclusion Criteria
|
| Age From |
21.00 Year(s) |
| Age To |
50.00 Year(s) |
| Gender |
Both |
| Details |
1. The patients between 21-50 years age
2. Patients with history of Alcoholic Fatty Liver Grade II
3. Patients with no known systemic disorders
4. Patients irrespective of sex, religion, socioeconomic status will be included.
5. Patients who are not under medication for any condition including ALDs
6. Patient with AUDIT score 16 and above.
7. In case of withdrawal of any participant new patient who fits to the above mentioned inclusion criteria will be included in the study for the completeness and accuracy of the data. |
|
| ExclusionCriteria |
| Details |
1. Patients below 21 years of age and above 50 years of age
2. Patients suffering from other systemic disease that interfere with the prognosis and treatment of disease.
3. Patients suffering from any sort of fatal diseases.
4. Patients with the History of more than 5 years.
5. Patients with Non-alcoholic Fatty Liver (NAFLD).
6. Patients with Alcoholic Fatty Liver Grade I, Alcoholic Fatty Liver Grade III, Alcoholic Hepatitis, Cirrhosis, Liver Failure and any other liver diseases which is not caused by Alcoholic Fatty Liver Grade II.
7. The patients who are already under treatment for AFLD/NAFLD or were under the treatment for the above said conditions from any medical system till minimum two weeks prior to the conduct of the study. |
|
|
Method of Generating Random Sequence
|
Computer generated randomization |
|
Method of Concealment
|
Not Applicable |
|
Blinding/Masking
|
Open Label |
|
Primary Outcome
|
| Outcome |
TimePoints |
| The primary outcome of the study is the reduction in liver fat content and improvement in liver function in patients with Alcoholic Fatty Liver Grade II. |
6 Months |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| The secondary outcome focuses on the alleviation of symptoms and improvement in the quality of life of patients. |
6 Months |
|
|
Target Sample Size
|
Total Sample Size="200"
Sample Size from India="200"
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 3 |
|
Date of First Enrollment (India)
|
01/12/2025 |
| 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="0"
Months="6"
Days="2" |
|
Recruitment Status of Trial (Global)
|
Not Yet Recruiting |
| Recruitment Status of Trial (India) |
Open to Recruitment |
|
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
|
This Study is randomized, controlled, open-label, clinical study to evaluate the efficacy of 24ml twice a day of srikhandasava and 24ml twice a day of patolakaturohinyadi kashaya for 2 months in 200 patients with alcoholic fatty liver grade ii that will be conducted in the IPD patients of National College of ayurveda and hospital, Barwala. The primary out come measure will be the reduction in liver fat content and improvement in liver function in patients with Alcoholic Fatty Liver Grade Il. The secondary outcome will be focuses on the alleviation of symptoms and improvement in the quality of life of patients. |