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Effect of Livogrit on Quality of Life in Patients with Non-Alcoholic Fatty Liver Disease

Not yet recruiting
Conditions
Fatty (change of) liver, not elsewhere classified. Ayurveda Condition: YAKRUDDALYUDARAH,
Registration Number
CTRI/2025/06/089641
Lead Sponsor
Patanjali Research Foundation
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.

Detailed Description

Not available

Recruitment & Eligibility

Status
Not Yet Recruiting
Sex
All
Target Recruitment
91
Inclusion Criteria
  • Established case of NAFLD (Grade I & II).
  • The subject is able and willing to provide consent.
Exclusion Criteria
  • 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.

Study & Design

Study Type
Observational
Study Design
Not specified
Primary Outcome Measures
NameTimeMethod
Changes in the Chronic Liver Disease Questionnaire for NAFLD NASHbaseline (Day 1) to Day 90
Secondary Outcome Measures
NameTimeMethod
Changes in Liver Function Test (LFT)baseline (Day 1) to Day 90

Trial Locations

Locations (3)

Patanjali Ayurveda Hospital

🇮🇳

Hardwar, UTTARANCHAL, India

Patanjali Wellness

🇮🇳

Hardwar, UTTARANCHAL, India

Patanjali Yoggram

🇮🇳

Hardwar, UTTARANCHAL, India

Patanjali Ayurveda Hospital
🇮🇳Hardwar, UTTARANCHAL, India
Dr Kumud Chauhan
Principal investigator
07456938311
kumudchauhan3@gmail.com

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