Management of NAFLD through Ayurveda

Not Applicable

Conditions: Health Condition 1: E889- Metabolic disorder, unspecified

Registration Number: CTRI/2022/02/040321

Lead Sponsor: CCRAS

Brief Summary: Not available

Detailed Description: Not available

Recruitment & Eligibility

Status: ot Yet Recruiting

Sex: Not specified

Target Recruitment: 0

Inclusion Criteria

Diagnosed cases of Grade- I&II of Non-alcoholic fatty liver disease as evident fatty infiltration on Ultrasound.

Either sex aged between18- 60 years.

Subjects of non-alcoholic fatty liver disease with their hepatic enzymes <2 times upper normal limit (Normal limits AST 5-40U/L and ALT 7-56U/L).

Willing to provide written consent and able to participate for 4 months in the study.

Exclusion Criteria

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

Any other identified cause of chronic liver disease

The use of medication which would cause non-alcoholic fatty liver - disease e.g. tamoxifen

Already taking supplementary medicine for NAFLD

On anticoagulants (antiplatelet aggregators are permitted)

Past history of Cardiac Arrhythmia, Acute Coronary Syndrome, Myocardial Infarction, Stroke or Severe Arrhythmia in the last 6 months.

Symptomatic patients with clinical evidence of congestive cardiac failure.

Subjects with concurrent Renal Dysfunction (defined as S. creatinine > 1.2 mg/dl), uncontrolled Pulmonary Dysfunction (asthmatic and COPD patients) or other concurrent severe disease.

Uncontrolled Diabetes Mellitus (HbA1C >8)

Known cases of HIV and AIDS, malignancy, Hepatitis B

Subjects participated in any other clinical trial.

Women who are planning for conception / pregnant or lactating.Any other condition which the P.I. thinks may jeopardize the study.

Study & Design

Study Type: Interventional

Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Change in fibroscan score (Kpa) and CAP value (Kpa) which signifies fibrosis and steatosis status respectively. <br/ ><br>Timepoint: Baseline& 90th day

Secondary Outcome Measures

Name	Time	Method
To assess changes in ALT, AST, Serum bilirubin, Total proteins & Alkaline Phosphatase <br/ ><br> <br/ ><br>Changes in Lipid profile <br/ ><br>Changes in HbA1C <br/ ><br> <br/ ><br>Change in BMI <br/ ><br>To measure change in Fatty Liver Index <br/ ><br>To assess any biological intolerability or adverse events during the trial period <br/ ><br> <br/ ><br> <br/ ><br>Timepoint: Baseline, 90th day