| CTRI Number |
CTRI/2025/06/089641 [Registered on: 26/06/2025] Trial Registered Prospectively |
| Last Modified On: |
20/06/2025 |
| Post Graduate Thesis |
No |
| Type of Trial |
Observational |
|
Type of Study
|
Follow Up Study |
| Study Design |
Single Arm Study |
|
Public Title of Study
|
Effect of Livogrit on Quality of Life in Patients with Non-Alcoholic Fatty Liver Disease |
|
Scientific Title of Study
|
Evaluation of the Impact of Ayurvedic Formulation Livogrit on Quality of Life in Patients with Non-Alcoholic Fatty Liver Disease Prospective open label single arm observational 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 Kumud Chauhan |
| Designation |
Physician Resident Medical Officer |
| Affiliation |
Patanjali Yoggram Yog Naturopathy Panchkarma Treatment and Research Centre |
| Address |
OPD No 16
Panchkarma Department
Patanjali Yoggram Yog Naturopathy Panchkarma Treatment and Research Centre
Yoggram Village Aurangabad Near SIDCUL Roshnabad Haridwar Uttarakhand India 249402
Hardwar
UTTARANCHAL
249402
India |
| Phone |
07456938311 |
| Fax |
|
| Email |
kumudchauhan3@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Kumud Chauhan |
| Designation |
Physician Resident Medical Officer |
| Affiliation |
Patanjali Yoggram Yog Naturopathy Panchkarma Treatment and Research Centre |
| Address |
OPD No 16
Panchkarma Department
Patanjali Yoggram Yog Naturopathy Panchkarma Treatment and Research Centre
Yoggram Village Aurangabad Near SIDCUL Roshnabad Haridwar Uttarakhand India 249402
Hardwar
UTTARANCHAL
249402
India |
| Phone |
07456938311 |
| Fax |
|
| Email |
kumudchauhan3@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Dr Kumud Chauhan |
| Designation |
Physician Resident Medical Officer |
| Affiliation |
Patanjali Yoggram Yog Naturopathy Panchkarma Treatment and Research Centre |
| Address |
OPD No 16
Panchkarma Department
Patanjali Yoggram Yog Naturopathy Panchkarma Treatment and Research Centre
Yoggram Village Aurangabad Near SIDCUL Roshnabad Haridwar Uttarakhand India 249402
Hardwar
UTTARANCHAL
249402
India |
| Phone |
07456938311 |
| Fax |
|
| Email |
kumudchauhan3@gmail.com |
|
|
Source of Monetary or Material Support
|
| Patanjali Research Foundation governed by Patanjali Research Foundation Trust NH 58 Near Bahadrabad Haridwar 249405 Uttarakhand India |
|
|
Primary Sponsor
|
| Name |
Patanjali Research Foundation |
| Address |
NH 58 Near Bahadrabad Haridwar 249405 Uttarakhand India |
| Type of Sponsor |
Research institution |
|
|
Details of Secondary Sponsor
|
|
|
Countries of Recruitment
|
India |
|
Sites of Study
|
| No of Sites = 3 |
| Name of Principal
Investigator |
Name of Site |
Site Address |
Phone/Fax/Email |
| Dr Kumud Chauhan |
Patanjali Ayurveda Hospital |
OPD No 31 Panchkarma Department Patanjali Yogpeeth Maharshi Dayanand Gram Delhi Haridwar National Highway Near Bahadarbad Haridwar 249405 Uttarakhand India
Hardwar
UTTARANCHAL |
07456938311
kumudchauhan3@gmail.com |
| Dr Kumud Chauhan |
Patanjali Wellness |
OPD No 36 Panchkarma Department Patanjali Wellness Delhi Haridwar National Highway Near Bahadrabad Haridwar 249405 Uttarakhand India
Hardwar
UTTARANCHAL |
07456938311
kumudchauhan3@gmail.com |
| Dr Kumud Chauhan |
Patanjali Yoggram |
OPD No 16 Panchkarma Department Patanjali Yoggram Yog Naturopathy Panchkarma Treatment and Research Centre Yoggram Village Aurangabad Near SIDCUL Roshnabad Haridwar Uttarakhand India 249402
Hardwar
UTTARANCHAL |
7456938311
kumudchauhan3@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| PATANJALI AYURVED COLLEGE 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: YAKRUDDALYUDARAH, |
|
|
Intervention / Comparator Agent
|
| sno | Intervention/Comparator | Type | Drug-Type | Procedure Name | Details |
|
| Intervention |
Nil |
Nil |
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
65.00 Year(s) |
| Gender |
Both |
| Details |
Established case of NAFLD (Grade I & II).
The subject is able and willing to provide consent. |
|
| ExclusionCriteria |
| Details |
Alcohol associated liver disease (ALD) engage in heavy drinking about 4 or more drinks per day (56g) or 8 (112 g) or more drinks per week for women and 5 or more drinks per day (70 g) or 15 (210 g) or more drinks per week for men and other causes of liver disease.
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.
Inability to attend follow-up session.
Pregnant, lactating women or pregnancy anticipated during study.
Diagnosed cases of Diabetes.
Thyroid disease not controlled by medication.
Uncontrolled Hypertension.
Patient on Anti-tubercular therapy.
Known cases of endocrine disorders including Cushing’s syndrome or history of long term steroid intake or any other secondary causes of fatty liver.
Patients with complications of Metabolic syndrome like Cerebrovascular Accident Myocardial Infarction Chronic Kidney disease.
Patient not willing to give written informed consent.
|
|
|
Method of Generating Random Sequence
|
Not Applicable |
|
Method of Concealment
|
Not Applicable |
|
Blinding/Masking
|
Not Applicable |
|
Primary Outcome
|
| Outcome |
TimePoints |
| Changes in the Chronic Liver Disease Questionnaire for NAFLD NASH |
baseline (Day 1) to Day 90 |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| Changes in Liver Function Test (LFT) |
baseline (Day 1) to Day 90 |
|
|
Target Sample Size
|
Total Sample Size="91"
Sample Size from India="91"
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)
|
07/07/2025 |
| 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="3"
Months="0"
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 is a single arm, open label, prospective, observational study evaluating the effectiveness of Livogrit in Subjects with Non alcoholic fatty liver disease (NAFLD). Data will be collected from three study sites and subjects will be followed up for next 90 days. The Chronic Liver Disease Questionnaire NAFLD NASH will be used to evaluate the quality of life and the effectiveness will be assessed by Liver function test after 90 days. |