| CTRI Number |
CTRI/2025/04/084339 [Registered on: 07/04/2025] Trial Registered Prospectively |
| Last Modified On: |
08/04/2025 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Drug
Ayurveda
Behavioral |
| Study Design |
Randomized, Parallel Group, Placebo Controlled Trial |
|
Public Title of Study
|
Evaluating the effect of Punarnavashtak Ghana and life style changes in Metabolic Associated Fatty Liver Disease |
|
Scientific Title of Study
|
A randomised double-blind placebo controlled study to evaluate the effect of Punarnavashtak Ghana along with Lifestyle modification in Metabolic associated Fatty
liver disease (MAFLD) with special reference to Yakrit Vikar |
| 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 Devkanya Khatediya |
| Designation |
PG scholar |
| Affiliation |
Parul Institute of Ayurved and research |
| Address |
Department of Kayachikitsa 3rd floor room no. 406 Parul Institute of Ayurved and research Parul University,P.O Limda,391760,vadodara,Gujrat,India
Vadodara
GUJARAT
391760
India |
| Phone |
7974318848 |
| Fax |
|
| Email |
khatediyadevkanya@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Vaishali Deshpande |
| Designation |
Guide( HODand Professor) |
| Affiliation |
Parul Institute of Ayurved and research |
| Address |
Parul Institute of Ayurved and Research Department of Kayachikitsa, Parul University,Ishwarpura Limda,391760,vadodara,Gujrat,India
Vadodara
GUJARAT
391760
India |
| Phone |
9096082950 |
| Fax |
|
| Email |
dr.vaishalid@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Dr Devkanya Khatediya |
| Designation |
PG scholar |
| Affiliation |
Parul Institute of Ayurved and research |
| Address |
Department of Kayachikitsa 3rd floor room no. 406 Parul Institute of Ayurved and research Parul University, P.O Limda,391760,vadodara,Gujrat,India
Vadodara
GUJARAT
391760
India |
| Phone |
7974318848 |
| Fax |
|
| Email |
khatediyadevkanya@gmail.com |
|
|
Source of Monetary or Material Support
|
| Parul Institute of Ayurved and research Department of Kayachikitsa 3rd floor room no Parul
University,Ishwarpura Limda,391760,vadodara,Gujrat,India. |
|
|
Primary Sponsor
|
| Name |
DrDevkanya Khatediya |
| Address |
Department of Kayachikitsa Parul Institute of Ayurved and Research
Parul University, P.O Limda,391760,vadodara,Gujrat,India |
| 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 Devkanya khatediya |
Khemdas hospital |
OPD NO 8, Ground Floor, Department of Kayachikitsa, Khemdas Hospital, Parul Institute of Ayurved and Research
P.O Limda,vadodara,Gujrat,India.391760
Vadodara
GUJARAT |
7974318848
khatediyadevkanya@gmail.com |
|
Details of Ethics Committee
Modification(s)
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Institutional Ethical Committee, PIAR-IECHR |
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 | Drug | Other than Classical | | (1) Medicine Name: Placebo, Reference: NA, Route: Oral, Dosage Form: Capsules, Dose: 500(mg), Frequency: bd, Bhaishajya Kal: Adhobhakta, Duration: 3 Months, anupAna/sahapAna: Yes(details: Ushna Jala), Additional Information: Lifestyle modification (balanced diet and moderate physical activity) | | 2 | Intervention Arm | Drug | Classical | | (1) Medicine Name: Punarnavashtak Ghana, Reference: Bhaishajratnavali , Route: Oral, Dosage Form: Gutika/Vati/Ghana Vati/ Tablets, Dose: 500(mg), Frequency: bd, Bhaishajya Kal: Adhobhakta, Duration: 3 Months, anupAna/sahapAna: Yes(details: -ushna jala), Additional Information: - |
|
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
65.00 Year(s) |
| Gender |
Both |
| Details |
1.Patient of either sex between the age of 18 to 65 year.
2.Patients fulfilling diagnostic criteria as mentioned in brief summary.
3.Sonologically diagnosed and fresh cases with grade 1 and grade 2 fatty liver .
4.Patient who are willing for participation in the trial, ready to undergo study related procedures and fill the consent form.
|
|
| ExclusionCriteria |
| Details |
1.Alcoholic steatohepatitis
2.K/C/O hepatitis B and C, cirrhosis of liver, Jaundice
3.Pregnant and lactating women.
4.The prescription of medication which would cause MAFLD ex.tamoxifen
5.Already taking supplementary medicine for NAFLD
6.Patient who has past history of cardiac Arrythmia, Acute coronary syndrome, myocardial infarction, symptomatic patient with clinical evidence of cardiac failure. |
|
|
Method of Generating Random Sequence
|
Permuted block randomization, fixed |
|
Method of Concealment
|
Not Applicable |
|
Blinding/Masking
|
Participant and Investigator Blinded |
|
Primary Outcome
|
| Outcome |
TimePoints |
| To study effect of Punarnavashtak Ghana with life style modification in comparision with placebo with life style modification on the basis of subjective parameter from baseline to end of study. |
0 DAYS 30 DAYS 60 DAYS 90 DAYS |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
To study the the effect of Punarnavashtak Ghana with life style modification in comparision with placebo on 1.Lipid profile
2.SGOT (AST), SGPT(ALT) levels
3.Weight and BMI
4.FIB-4 score
5.APRI score
6. BARD score from baseline to end of study. |
0 DAYS & 90 DAYS |
|
|
Target Sample Size
|
Total Sample Size="68"
Sample Size from India="68"
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)
|
15/05/2025 |
| 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 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
|
This study is a randomizes double-blind placebo controlled clinical trial designed to evaluate the effect of Punarnavashtak Ghana a classical ayurvedic formulation along with lifestyle modification in the management of Metabolic Associated Fatty Liver Disease (MAFLD) with special reference to Yakrit Vikar as described in ayurveda.
The study aims to assess the imapact of Punarnavashtak Ghana on the basis of subjective and objective criteria and the diagnosis will be done on the basis of three phase screening- Phase 1 screening- At least one of the following criteria- 1.Obesity/overwight(BMI)>25 kg/m2 with symptoms 2.Presence of type 2 diebetes mallitus 3.Metabolic dysregulation defined by the presence of at least two of the seven metabolic risk criteria- Phase 2 screening- for Metabolic Dysregulation at least 2 of the 7 metabolic risk criteria 1.waist circumference >94 cm in male and >80 cm in women 2.BP >130/85 mmhg 3.plasma tryglyceride >150mg/dl 4.HDL cholestrol <40mg/dl for men and <50 mg /dl for women 5.Homa insulin resistance score>2.5 6. Plasma CRP >2mg/dl 7.Prediebetes
Phase 3 screening- USG (abdomen)-Grade 1 to grade 2 Fatty liver changes After the diagnosis the medicine should be administered to the patients and the outcome will be noted on the basis of subjective and objective criteria. |