Efficacy of a polyherbal formulation and life style modification in the management of Non Alcoholic Fatty Liver Disease

Efficacy of a polyherbal formulation and life style modification in the management of yakritodar w.s.r to NAFLD - NIL

Status

Active, not recruiting

Phases

Phase 3

Study type

Interventional

Source

CTRI

Registry ID

CTRI/2024/08/071986

Enrollment

Registered

2024-08-06

Start date

Unknown

Completion date

Unknown

Last updated

2024-08-19

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Health Condition 1: K760- Fatty (change of) liver, not elsewhere classified

Interventions

None listed

Eligibility

Inclusion criteria

Inclusion criteria: 1.Pain in the upper and epigastric region/pain in the right upper quadrant, fullness of abdomen, feeling of nausea and vomiting, loss of appetite, constipation etc. 2.Elevated liver enzymes i.e. SGPT more than 1.5 times the normal value. 3.USG evidence of hepatomegaly with fatty changes in liver. 4. NAFLD Fibrosis score (NFS) range (less than -1.455 to 0.676). 5.Diagnosed NAFLD and referred from other outpatient departments 6. Patients who agreed to follow the study protocol and give constant for clinical trial.

Exclusion criteria

Exclusion criteria: 1.Patient below 18 years and above 65 years. 2.Patient who are not willing to come under trial or give consent. 3.NAFLD Fibrosis score (NFS) range (more or equal to 0.676). 4. Alcoholic steatohepatitis 5. Alcoholic fatty liver (typically, a threshold of more than 20g/day for woman and more than 30g/day for men), ALT more or equal to 120 IU/L, total parental nutrition 6. Liver cirrhosis/fibrosis, heart or renal failure. 7. Underwent liver transplantation, gastrointestinal surgery. 8.Vascular diseases of the liver, allergy, liver mass. 9. H/o or presence of Type 1 DM 10.Presence of any other form of chronic liver disease 11.Hepatitis (A, B, C, D, E) positive patients 12.Wilsons disease or metabolic liver disease 13.Polycystic liver disease 14.Cystic fibrosis of liver 15.Non Alcoholic cirrhosis 16.Auto immune hepatitis 17.Primary and secondary Hepatic cellular Carcinoma (HCC) 18.STD’s 19.Gilbert disease 20.alpha 1 antitrypsin deficiency 21.Pregnant and lactating mother 22.History of heart attack or stroke 23.Mentally disabled patients

Design outcomes

Primary

Measure	Time frame
TO REDUCE THE SGPT LEVELS WITHIN THE NORMAL RANGETimepoint: 90 days	—

Secondary

Measure	Time frame
NAFLD FIBROSIS SCORE(NFS) less than -1.455Timepoint: 90 days	—

Countries

India

Contacts

Public ContactDr. Pratik Gupta

The West Bengal University of Health Sciences

dr.tapasbhaduri@gmail.com9836362763

Outcome results