| CTRI Number |
CTRI/2025/01/079000 [Registered on: 20/01/2025] Trial Registered Prospectively |
| Last Modified On: |
31/12/2024 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Drug
Ayurveda |
| Study Design |
Randomized, Parallel Group, Active Controlled Trial |
|
Public Title of Study
|
To study Non-Alcoholic Fatty Liver Disease in both males and females and management through Ayurveda. |
|
Scientific Title of Study
|
An Etiopathological Study of Medosamchaya in Yakrit [Non- Alcoholic Fatty Liver Disease (NAFLD)] and Comparative Therapeutic Trial of Panchakola Churna and Lifestyle - Dietary Modification. |
| Trial Acronym |
NIL |
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Sruthi C |
| Designation |
MD Scholar |
| Affiliation |
Banaras Hindu University |
| Address |
Department of Vikriti Vigyan
Faculty of Ayurveda
Institute of Medical Science
Banaras Hindu University
Varanasi
Uttarpradesh
221005
India
Varanasi
UTTAR PRADESH
221005
India |
| Phone |
9744633359 |
| Fax |
|
| Email |
sruthipradeep80000@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Priyadarshini Tewari |
| Designation |
Assistant Professor |
| Affiliation |
Banaras Hindu University |
| Address |
Department of Vikriti Vigyan
Faculty of Ayurveda
Institite of Medical Science
Banaras Hindu University
Varanasi
Uttarpradesh
221005
India
Varanasi
UTTAR PRADESH
221005
India |
| Phone |
8090029260 |
| Fax |
|
| Email |
tewaripavy19@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Sruthi C |
| Designation |
MD Scholar |
| Affiliation |
Banaras Hindu University |
| Address |
Department of Vikriti Vigyan
Faculty of Ayurveda
Institite of Medical Science
Banaras Hindu University
Varanasi
Uttarpradesh
221005
India
Varanasi
UTTAR PRADESH
221005
India |
| Phone |
9744633359 |
| Fax |
|
| Email |
sruthipradeep80000@gmail.com |
|
|
Source of Monetary or Material Support
|
| Department of Vikriti Vigyan Faculty of Ayurveda IMS BHU Varanasi Uttar pradesh |
|
|
Primary Sponsor
|
| Name |
Faculty of Ayurveda Institute of Medical Science Banaras Hindu University |
| Address |
Department of Vikriti Vigyan
Faculty of Ayurveda
Institute of Medical Science
Banaras Hindu University
Varanasi
Uttarpradesh
221005
India |
| Type of Sponsor |
Government medical college |
|
|
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 |
| DrSruthi C |
SS Hospital,Institute of Medical Science, Vraranasi,221005, Uttarpradesh,India , |
Department of Vikriti Vigyan
Institute of Medical Sciences
Banaras Hindu University
Varanasi
Uttarpradesh
Varanasi
UTTAR PRADESH |
9744633359
sruthipradeep80000@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Institutional Ethics Committe |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition:K760||Fatty (change of) liver, not elsewhere classified. Ayurveda Condition: YAKRUDDALYUDARAH, |
|
|
Intervention / Comparator Agent
|
| sno | Intervention/Comparator | Type | Drug-Type | Procedure Name | Details | | 1 | Comparator Arm | Lifestyle | - | - | Dinacarya: , Ritucarya: , Acara Rasayana:, Other:, Pathya/Apathya:yes, Pathya:Daal(without fry),Boiled vegetables,Egg white,Bengal gram,Barley, Apathya:Fatty foods,Non-veg,Egg yolk,Dry fruits,Ghee,Butter,Milk-cream,Preserved food like pickle,Cold drink,Soft drink,Salt | | 2 | Intervention Arm | Drug | Classical | | (1) Medicine Name: Panchakola churnam, Reference: Shargdhar samhita, Route: Oral, Dosage Form: Churna/ Powder, Dose: 3(g), Frequency: bd, Bhaishajya Kal: Adhobhakta, Duration: 60 Days, anupAna/sahapAna: Yes(details: -Luke warm water), Additional Information: - |
|
|
|
Inclusion Criteria
|
| Age From |
30.00 Year(s) |
| Age To |
70.00 Year(s) |
| Gender |
Both |
| Details |
1)Subject with NAFLD Grade 1 and Grade2 (mild and moderate fatty infiltration as per USG findings.)
2)Age group of 30-70 years both male and females.
3)Subject willing to give informed consent and participate in the study
|
|
| ExclusionCriteria |
| Details |
1)Diagnosed cases of Renal, Respiratory, Cardiovascular and Neurological disorder
2)Subject with Hepatocellular Carcinoma and Cirrhosis
3)USG finding suggestive of fatty liver grade 3 and 4
4)Pregnant ladies and Lactating mothers
5) Those who are consuming Alcohol. |
|
|
Method of Generating Random Sequence
|
Computer generated randomization |
|
Method of Concealment
|
Not Applicable |
|
Blinding/Masking
|
Not Applicable |
|
Primary Outcome
|
| Outcome |
TimePoints |
Detection of etiological factors in NAFLD.
Assessment of efficacy of Panchakola churna and Lifestyle and dietary modification in the management of NAFLD. |
Base line and after 60 Days |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
1)To assess the changes in grading of fatty liver as identified by echogenecity of fatty liver through USG abdomen.
2)To assess the changes in LFT and Lipid profile. |
60 days |
|
|
Target Sample Size
|
Total Sample Size="54"
Sample Size from India="54"
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)
|
20/01/2025 |
| 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="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
|
132 patients having NAFLD will be surveyed out of 54 patients selected as per inclusion criteria will be randomly divided into 2 interventional group will be given Panchakola churna and Lifestyle -Dietary modification and other group will be given with Lifestyle -Dietary modification .The result will be statistically analyzed. |