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Management of non alcoholic fatty liver disease in Ayurveda

Phase 2
Conditions
Health Condition 1: K760- Fatty (change of) liver, not elsewhere classifiedHealth Condition 2: K760- Fatty (change of) liver, not elsewhere classifiedHealth Condition 3: K760- Fatty (change of) liver, not elsewhere classifiedHealth Condition 4: E888- Other specified metabolic disorders
Registration Number
CTRI/2022/06/043419
Lead Sponsor
Central Council for Research in Ayurvedic Sciences
Brief Summary

Not available

Detailed Description

Not available

Recruitment & Eligibility

Status
ot Yet Recruiting
Sex
Not specified
Target Recruitment
0
Inclusion Criteria

1.Either sex aged between 18-65 years.

2.Diagnosed cases of Grade- I&II of non-alcoholic fatty liver disease as evident by fatty infiltration by Ultrasound evaluation (USG Abdomen)

3.Participants having BMI from 18.5 to 30

4.Subjects of non-alcoholic fatty liver disease with their hepatic enzymes <2 times upper normal limit.

5.Willing to provide informed consent and able to participate for 3 months in the study.

Exclusion Criteria

1.Any other identified cause of chronic liver disease or already taking supplementary medicine for NAFLD.

2.H/O habitual consumption of alcohol intake of >20g/day for women, >40g/day for men

3.Subjects who have a past history of Cardiac Arrhythmia, Acute Coronary Syndrome, Myocardial Infarction, Stroke or Severe Arrhythmia in the last 6 months.

4.Known case of malignancy, concurrent Renal Dysfunction, uncontrolled Pulmonary Dysfunction (asthmatic and COPD patients), Neurological disorders, severe psychiatric disorders, endocrinology or other concurrent severe disease.

5.Uncontrolled Diabetes Mellitus(HbA1C >8)

6.Subjects taking participation in any other clinical trial.

7.Pregnant or lactating women

8.Any other condition which PI think can jeopardize the study

Study & Design

Study Type
Interventional
Study Design
Not specified
Primary Outcome Measures
NameTimeMethod
Change in score of Fatty Liver Index (FLI)Timepoint: baseline and at the end of treatment (90 days)
Secondary Outcome Measures
NameTimeMethod
to assess changes in ALT AST Serum bilirubin Total proteins & Alkaline Phosphatase. Changes in triglyceride Change in BMI change in Fatty liver index, quality of life in terms of SF 36 score and to assess any biological intolerability or adverse events and to record the number of participants with any biological intolerability or adverse event during the trial period.Timepoint: baseline and at the end of treatment (90 days).
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