| CTRI Number |
CTRI/2021/11/038277 [Registered on: 26/11/2021] Trial Registered Prospectively |
| Last Modified On: |
26/07/2023 |
| Post Graduate Thesis |
No |
| Type of Trial |
Interventional |
|
Type of Study
|
Ayurveda |
| Study Design |
Randomized, Parallel Group, Active Controlled Trial |
|
Public Title of Study
|
Efficacy of Virechana followed by Gomutra-haritaki in the fatty liver disease? |
|
Scientific Title of Study
|
AN OPEN-LABEL RANDOMIZED CONTROL TRIAL TO COMPARE THE EFFICACY OF VIRECHANA & GOMUTRA-HARITAKI VERSUS URSODEOXYCHOLIC ACID (UDCA) ON NAFLD FIBROSIS SCORE AMONG NAFLD PATIENTS |
| Trial Acronym |
|
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Dr Anshul |
| Designation |
PhD Scholar |
| Affiliation |
Shri Krishna Ayush University |
| Address |
Department of Panchkarma, SKAU
Department of Panchkarma,Gaur Brahmin Ayurvedic college, Brahmanwas
Rohtak
HARYANA
136118
India |
| Phone |
7906909126 |
| Fax |
|
| Email |
dr.anshul17@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Ashish Mehta |
| Designation |
Professor and guide |
| Affiliation |
Shri Krishna Ayush University |
| Address |
Department of Panchkarma, SKAU
Dr Ashish Mehta, Profesor, Department of Panchkarma, SKAU Kurukshetra
Kurukshetra
HARYANA
136118
India |
| Phone |
08950375285 |
| Fax |
|
| Email |
drashishhmehta@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Dr Anshul |
| Designation |
PhD Scholar |
| Affiliation |
Shri Krishna Ayush University |
| Address |
Department of Panchkarma, SKAU
Department of Panchkarma,Gaur Brahmin Ayurvedic college, Brahmanwas
Rohtak
HARYANA
136118
India |
| Phone |
7906909126 |
| Fax |
|
| Email |
dr.anshul17@gmail.com |
|
|
Source of Monetary or Material Support
|
| Shri Krishna Government Ayurvedic college- Kurukshetra |
|
|
Primary Sponsor
|
| Name |
NAD |
| Address |
NAD |
| Type of Sponsor |
Other [NAD] |
|
|
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 |
| Anshul |
Shri Krishna Govt Ayurvedic college and hospital , Panchkarma |
OPD Panchkarma Department 29
IPD-16
Kurukshetra
HARYANA |
7906909126
dr.anshul17@gmail.com |
|
Details of Ethics Committee
Modification(s)
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| GBAC IEC |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition:K77||Liver disorders in diseases classified elsewhere. Ayurveda Condition: YAKRUDDALYUDARAH, |
|
|
Intervention / Comparator Agent
|
| sno | Intervention/Comparator | Type | Drug-Type | Procedure Name | Details | | 1 | Intervention Arm | Procedure | - | Panchkarma | (Procedure Reference: Charak chikitsa udar rog, Procedure details: After proper Deepana Pachana with Chitrakaadi vati , Snehpana with Shatpala ghrit, Virechana with Trivrit awaleha will be administered followed by Gomuta-Hritaki)
(1) Medicine Name: Gomutra haritaki , Reference: Vata rakta, Route: Oral, Dosage Form: Gutika/Vati/Ghana Vati/Tablets, Dose: 10(g), Frequency: bd, Duration: 30 Days | | 2 | Comparator Arm (Non Ayurveda) | | - | UDCA | Ursodeoxycholic acid (UDCA) will be given at a dose of 300 mg/day after meal.
Total Duration of Treatment: 60days
Follow up: Total duration of the study was 02 months in which regular follow-ups of the enrolled patients were being done every 30 days for successive 2 months. |
|
|
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Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
60.00 Year(s) |
| Gender |
Both |
| Details |
• NAFLD confirmed by NFS score with or without having symptoms like fatigue, mild discomfort in the upper quadrant of abdomen etc.
• NAFLD patients who are refractive to standard drugs of treatment.
• Willing and able to participate in study and given written informed consent.
• Yogya for Virechana
|
|
| ExclusionCriteria |
| Details |
• Excessive use of alcohol within 2 years prior to initial screening. Or alcohol intake more than 20g per day for female and less than 30 g per day for males
• Uncontrolled systemic disease or medically unstable and major psychological disorders
• Any dysfunction of liver besides non-alcoholic fatty liver disease like viral hepatitis liver parenchymal disease, ascites, portal hypertension, Hepato-cellular carcinoma, Auto- immune hepatitis, Primary biliary cirrhosis, Wilsons disease, and liver transplantation or any other conditions interfering with the result of the treatment Alcoholic fatty liver disease patient
• Pregnant/lactating female
• Virechana ayogya |
|
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Method of Generating Random Sequence
|
Computer generated randomization |
|
Method of Concealment
|
Sequentially numbered, sealed, opaque envelopes |
|
Blinding/Masking
|
Open Label |
|
Primary Outcome
|
| Outcome |
TimePoints |
| 1. Improvement in NAFLD Fibrosis score (Age, Hyperglycaemia, BMI, platelet Count, Albumin, aspartate aminotransferase (AST) /Serum alanine aminotransferase (ALT) ratio) along with changes in clinical presentations (relief of the following symptoms like Fatigue, indigestion, epigastric discomfort, pain abdomen, diarrhea, constipation,) |
at baseline, 60th day
and 120th day. |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
1. Overall improvement in quality of life
2. USG Changes |
1- at baseline and 30th day, 60th day, 90th day and 120th day
2. baseline, 60 days, 120 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/ Phase 3 |
|
Date of First Enrollment (India)
|
30/11/2021 |
| 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="4"
Days="0" |
Recruitment Status of Trial (Global)
Modification(s)
|
Not Applicable |
| Recruitment Status of Trial (India) |
Closed to Recruitment of Participants |
|
Publication Details
|
|
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Individual Participant Data (IPD) Sharing Statement
|
Will individual participant data (IPD) be shared publicly (including data dictionaries)?
Response - YES
- What data in particular will be shared?
Response - Individual participant data that underlie the results reported in this article, after de-identification (text, tables, figures, and appendices).
- What additional supporting information will be shared?
Response - Study Protocol
Response - Statistical Analysis Plan
Response - Clinical Study Report
- Who will be able to view these files?
Response (Others) -
- For what types of analyses will this data be available?
Response (Others) -
- By what mechanism will data be made available?
Response (Others) -
- For how long will this data be available start date provided 24-11-2021 and end date provided 24-11-2021?
Response - Immediately following publication. No end date.
- Any URL or additional information regarding plan/policy for sharing IPD?
Additional Information - NIL
|
|
Brief Summary
|
we have taken Virechana followed by Gomutra haritaki. We presume that in the light of available scientific references and existing traditional usage, Ayurvedic regime would be effective in the treatment of NAFLD directed toward normalization of liver functions as well as to the reduction of insulin resistance. The present clinical trial was therefore designed to verify this hypothesis with the efforts in searching a more preferable drug having better cost-effectiveness for the treatment of patients with NAFLD. |