| CTRI Number |
CTRI/2025/02/080938 [Registered on: 19/02/2025] Trial Registered Prospectively |
| Last Modified On: |
04/02/2025 |
| Post Graduate Thesis |
No |
| Type of Trial |
Interventional |
|
Type of Study
|
Drug
Ayurveda |
| Study Design |
Randomized, Parallel Group, Placebo Controlled Trial |
|
Public Title of Study
|
Effect of Ayush PTK on metabolic parameters, and hepatic steatosis/fibrosis in Metabolic dysfunction associated steatotic liver disease. |
|
Scientific Title of Study
|
Effect of Ayush PTK on metabolic parameters, and hepatic steatosis or fibrosis in Metabolic dysfunction associated steatotic liver disease: A Randomised controlled trial. |
| 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 Shalimar |
| Designation |
Professor |
| Affiliation |
All India Institute of medical Sciences |
| Address |
Room No. 127, Old OT Block, Department of Gastroenterology, Ansari Nagar
South
DELHI
110029
India |
| Phone |
9868397211 |
| Fax |
|
| Email |
drshalimar@yahoo.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Shalimar |
| Designation |
Professor |
| Affiliation |
All India Institute of medical Sciences |
| Address |
Room No. 127, Old OT Block, Department of Gastroenterology, Ansari Nagar
DELHI
110029
India |
| Phone |
9868397211 |
| Fax |
|
| Email |
drshalimar@yahoo.com |
|
Details of Contact Person
Public Query
|
| Name |
Dr Shalimar |
| Designation |
Professor |
| Affiliation |
All India Institute of medical Sciences |
| Address |
Room No. 127, Old OT Block, Department of Gastroenterology, Ansari Nagar
DELHI
110029
India |
| Phone |
9868397211 |
| Fax |
|
| Email |
drshalimar@yahoo.com |
|
|
Source of Monetary or Material Support
|
| Centre of Advance Research, Extramural Grant, ICMR, Ansari Nagar, New Delhi,110029,Delhi |
|
|
Primary Sponsor
|
| Name |
ICMR |
| Address |
ICMR, Ansari Nagar, New Delhi-110029, Delhi |
| Type of Sponsor |
Government funding agency |
|
|
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 Shalimar |
All India Institute of Medical Sciences |
Seminar room, First floor, Old OT Block, Ansari Nagar
South
DELHI |
9868397211
drshalimar@yahoo.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Institute Ethics Committee |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition:K758||Other specified inflammatory liverdiseases. Ayurveda Condition: KLAIBYAM, |
|
|
Intervention / Comparator Agent
|
| sno | Intervention/Comparator | Type | Drug-Type | Procedure Name | Details | | 1 | Comparator Arm (Non Ayurveda) | | - | LIfestyle and Diet Modification | Patients will be advised for Lifestyle and diet modification for 1 year | | 2 | Intervention Arm | Drug | Other than Classical | | (1) Medicine Name: Ayush PTK, Reference: NA, Route: Oral, Dosage Form: Gutika/Vati/Ghana Vati/Tablets, Dose: 500(mg), Frequency: bd, Bhaishajya Kal: Abhakta, Duration: 1 Years, anupAna/sahapAna: No, Additional Information: - |
|
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
65.00 Year(s) |
| Gender |
Both |
| Details |
1. Patients with NAFLD/MASLD with elevated liver enzymes with or without fibrosis
2. Willing to give written consent for the study |
|
| ExclusionCriteria |
| Details |
1. Cirrhosis
2. Presence of other etiologies for fatty liver, eg alcohol, drugs, viral infections, autoimmune hepatitis
3. Uncontrolled diabetes
4. BMI greater than 35
5. AST or ALT greater than 5 times normal
6. Patients on Vit E, Saraglitazor, SGLT-2
7. Patients on Pioglitazone
8. Patients planned for Bariatric surgery or post-bariatric surgery
9. Planned for endoscopic interventions
10. Patients on bile acid chelators/ursodeoxycholic acid/obeticholic acid |
|
|
Method of Generating Random Sequence
|
Computer generated randomization |
|
Method of Concealment
|
Sequentially numbered, sealed, opaque envelopes |
|
Blinding/Masking
|
Not Applicable |
|
Primary Outcome
|
| Outcome |
TimePoints |
| Fraction of patients achieving greater than 30% MRI-PDFF change in each arm (responders) |
1 year |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
1. Change in liver enzymes- AST and ALT
2. Changes in BMI of patients in both arms (at baseline and at end of 1 year)
3. Changes in LSM, and CAP on Fibroscan
4. Insulin resistance and lipid profile
|
1. 1 year
2. 1 year
3. 1 year
4. 1 year |
|
|
Target Sample Size
|
Total Sample Size="179"
Sample Size from India="179"
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/ Phase 4 |
|
Date of First Enrollment (India)
|
28/02/2025 |
| 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="0"
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
|
The overall prevalence of NAFLD/MASLD in India is 38.6% among adults and 35.4% among children. Studies suggest that the prevalence of MASLD in Indian urban and rural populations is higher than the average estimated global prevalence of 25%. The entity of NAFLD encompasses a spectrum from simple steatosis to non-alcoholic steatohepatitis (NASH), which can progress to liver fibrosis, cirrhosis, and HCC. The treatment options for NAFLD/MASLD include diet and exercise, which are associated with poor compliance. Apart from control of comorbidities, including control of diabetes, the only available approved drug is Resmetirom. This drug has been approved by the U.S. FDA recently for managing patients with noncirrhotic nonalcoholic steatohepatitis (NASH or MASH) and moderate-to-advanced hepatic fibrosis. This drug has not been tested in the Indian population and is not available in India. There is an unmet need for therapeutic options for NAFLD/MASLD which affects almost 25% of the global population. In this proposal, we plan to study the Prakriti of patients with NAFLD/MASLD and correlate it with long-term outcomes. We also plan to conduct RCTs to assess the efficacy of Ayurvedic therapies in patients with NAFLD/MASLD |