Phalatrikadi guggul and Tab. Rosuvastatin in Nonalcoholic Fatty Liver Disease

Phase 2

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

Registration Number: CTRI/2023/05/052356

Lead Sponsor: Dr Vijayalaxmi Sujay patil

Brief Summary: Not available

Detailed Description: Not available

Recruitment & Eligibility

Status: Open to Recruitment

Sex: Not specified

Target Recruitment: 0

Inclusion Criteria

1.Nonalcoholics, or history of alcohol intake less than 20gm/day (history of alcohol intake will taken separately obtained from the patient and close relatives).

2.Clinical sign and symptoms suggesting NAFLD / Medodushti,i.e. pain in the Right upper quadrant/ epigastric region of the abdomen, feeling of nausea and vomiting, loss of appetite, burning sensation in the abdomen.

3.No complaints – incidental finding during investigations for some other disease.

4.Ultrasonography (USG) abdomen suggestive of NAFLD.

5.Biochemical : Liver function tests showing raised alanine transaminases (ALT) or aspartate transaminases (AST) levels raised above the normal limits (40 IU/L up to 300 IU/L) and wiyh or without raised lipid profile.

6.HbA1c < 9 gm/dl.

7.BMI < 40.

Exclusion Criteria

1.Patients with a H/O alcohol intake exceeding 20g/d (history of alcohol consumption history shall be separately obtained from the patient and close relatives)

2.Patients testing positive for markers of other Viral Hepatitis.

3.Pregnant women, Lactating mother.

4.Patient suffering from Alcoholic Fatty Liver Disease and Nonalcoholic Steatohepatitis (NASH).

5.Patients with complications of Nonalcoholic Fatty Liver Disease like Cardiovascular and Renal complications.

6.Patients having Cholecystitis, Pancreatitis or any acute inflammatory condition.

7.Patients having Uncontrolled DM (HbA1c > 9).

8.Patients having major systemic illness like CA, Renal failure, HIV, IHD, Cirrhosis of Liver, Severe anaemia (Hb < 7gm%).

9.BMI > 40

10.Patients participating / participated in another clinical drug study within 3 months before recruitment.

Study & Design

Study Type: Interventional

Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
To evaluate the effect of Phalatrikadi Guggul on 1.Biochemical tests : Lipid profile, LFTs, Sr. Insulin, BSL random. <br/ ><br>2.Radiological : USG abdomen. <br/ ><br>Timepoint: Inclusion 30th day 60th day

Secondary Outcome Measures

Name	Time	Method
To compare the effect of Phalatrikadi guggul and Tab Rosuvastatin on the basis of Subjective criteria Udarshool Utklesh Klama Agnimandya Aadhman and Objective criteria 1.Biochemical tests : Lipid profile, LFTs, Sr. Insulin, BSL random. <br/ ><br>2.Radiological : USG abdomen. <br/ ><br>Timepoint: Inclusion 30th day 60th day