| CTRI Number |
CTRI/2023/06/054489 [Registered on: 27/06/2023] Trial Registered Prospectively |
| Last Modified On: |
23/01/2024 |
| Post Graduate Thesis |
No |
| Type of Trial |
Interventional |
|
Type of Study
|
Ayurveda |
| Study Design |
Single Arm Study |
|
Public Title of Study
|
Effect of Triphala in Non-alcoholic fatty liver changes |
|
Scientific Title of Study
|
Investigating effect of Triphala in patients suffering from Non-alcoholic fatty liver disease (NAFLD): a proof of concept clinical study |
| 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 Poonam Gupte |
| Designation |
Senior Research Assistant |
| Affiliation |
Interactive Research School For Health Affairs Bharati Vidyapeeth (Deemed to be University), Pune |
| Address |
Obesity- Diabetes Lab, First floor, Interactive Research School For Health Affairs (IRSHA), Bharati Vidyapeeth Educational Campus, Pune – Satara Road, Pune –411 043 Maharashtra
Pune
MAHARASHTRA
411043
India |
| Phone |
9422006041 |
| Fax |
|
| Email |
Poonam.gupte@bharatividyapeeth.edu |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Poonam Gupte |
| Designation |
Senior Research Assistant |
| Affiliation |
Interactive Research School For Health Affairs Bharati Vidyapeeth (Deemed to be University), Pune |
| Address |
Obesity- Diabetes Lab, First floor, Interactive Research School For Health Affairs (IRSHA), Bharati Vidyapeeth Educational Campus, Pune – Satara Road, Pune –411 043 Maharashtra
MAHARASHTRA
411043
India |
| Phone |
9422006041 |
| Fax |
|
| Email |
Poonam.gupte@bharatividyapeeth.edu |
|
Details of Contact Person
Public Query
|
| Name |
Dr Revati Bhat |
| Designation |
Clinical Study Co-ordinator |
| Affiliation |
Interactive Research School For Health Affairs Bharati Vidyapeeth (Deemed to be University), Pune |
| Address |
Obesity- Diabetes Lab, First floor, Interactive Research School For Health Affairs (IRSHA), Bharati Vidyapeeth Educational Campus, Pune – Satara Road, Pune –411 043 Maharashtra
Pune
MAHARASHTRA
411043
India |
| Phone |
9096943323 |
| Fax |
|
| Email |
revabhat.1610@gmail.com |
|
|
Source of Monetary or Material Support
|
| Bharati Vidyapeeth (Deemed-to-be) University.
Bharati Vidyapeeth Bhavan, Lal Bahadur Shastri Rd, Joshi Wada, Sadashiv Peth, Pune, Maharashtra 411030 |
|
|
Primary Sponsor
|
| Name |
Bharati Vidyapeeth Deemedtobe University |
| Address |
Bharati Vidyapeeth Bhavan, Lal Bahadur Shastri Rd, Joshi Wada, Sadashiv Peth, Pune, Maharashtra 411030 |
| Type of Sponsor |
Other [University] |
|
|
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 Revati Bhat |
Bharati Hospital and Research Centre |
Gastroenterology Outpatient Department, First Floor, New Building, Bharati Hospital and Research Centre
Pune
Pune
MAHARASHTRA |
02040555555
revabhat.1610@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| BHARATI VIDYAPEETH (DEEMED to be UNIVERSITY) MEDICAL COLLEGE INSTITUTIONAL ETHICS COMMITTEE |
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: MEDOROGAH, |
|
|
Intervention / Comparator Agent
|
| sno | Intervention/Comparator | Type | Drug-Type | Procedure Name | Details | | 1 | Intervention Arm | Drug | Classical | | (1) Medicine Name: Triphala, Reference: Charak Samhita, Route: Oral, Dosage Form: Gutika/Vati/Ghana Vati/ Tablets, Dose: 500(mg), Frequency: bd, Bhaishajya Kal: Sabhakta, Duration: 3 Months, anupAna/sahapAna: Yes(details: Water), Additional Information: - |
|
|
|
Inclusion Criteria
|
| Age From |
30.00 Year(s) |
| Age To |
60.00 Year(s) |
| Gender |
Both |
| Details |
1.Individuals of either sex between the age group of 30 - 60 years
2.Individuals with BMI ≥ 27.5 kg/m2- ≤ 35 kg/m2
3.Individuals with presence of NAFLD grade II or above on Ultrasound
4.Individuals willing to abide by the study related procedures |
|
| ExclusionCriteria |
| Details |
1.Individuals with secondary obesity e.g. Prader-Willi syndrome, Corticosteroid induced obesity, or other endocrine disorders
2.Individuals with alcohol addiction
3.Individuals with viral hepatitis disorders (Hepatitis B, Hepatitis C)
4.Individuals with known history of usage of herbal medications/ nutritional supplements/ multivitamin supplements/ pre and probiotic supplementation within past 30 days for any indication
5.Pregnant or lactating females |
|
|
Method of Generating Random Sequence
|
Other |
|
Method of Concealment
|
Not Applicable |
|
Blinding/Masking
|
Open Label |
|
Primary Outcome
|
| Outcome |
TimePoints |
Assessment Parameters:
Fatty liver changes by FibroScan
Lipid profile, Complete blood count, Liver profile, Renal Profile, Fasting Insulin, Fasting blood glucose
Body weight, BMI and waist circumferences
Expected outcomes:
1.10% improvement in fatty liver changes due to Triphala
2.10% improvement in insulin resistance due to Triphala |
Day 0 & Day 90 |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| 10% improvement in the anthropometry due to Triphala |
Day 0, Day 30,Day 60 & Day 90 |
|
|
Target Sample Size
|
Total Sample Size="8"
Sample Size from India="8"
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
|
N/A |
|
Date of First Enrollment (India)
|
01/07/2023 |
| 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="0" |
Recruitment Status of Trial (Global)
Modification(s)
|
Not Applicable |
| 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
|
Objectives:To determine the effect of Triphala on fatty liver changes To evaluate the effect of Triphala on insulin resistance To assess the effect of Triphala on weight and waist circumferences
Methodology: This is a randomised, single arm clinical study. Study Groups: There will be a single group of individuals receiving tablets made from Triphala aqueous extract (n=6).
Dosage: Triphala tablets (each weighing 500 mg) will be administered in the dose of 3 tablets twice a day post meals with water. Duration of treatment: 3 months
Evaluation Parameters: waist circumference and body composition analysis, fasting glucose, fasting insulin, glycosylated hemoglobin, lipid profile, complete blood count, liver function tests (AST, ALT), platelet count and kidney function (Creatinine, Blood Urea Nitrogen) Time Points : Day 0, Day 30, Day 60, Day 90
Expected Outcome: Triphala tablets will prove beneficial in NAFLD |