Phalatrikadi guggul and Tab. Rosuvastatin in Nonalcoholic Fatty Liver Disease

Randomized controlled clinical trial to compare the efficacy of Phalatrikadi Guggul with tablet Rosuvastatin in Medodushti with special reference to Nonalcoholic Fatty Liver Disease - NIL

Status

Recruiting

Phases

Phase 2Phase 3

Study type

Interventional

Source

CTRI

Registry ID

CTRI/2023/05/052356

Enrollment

134

Registered

2023-05-08

Start date

Unknown

Completion date

Unknown

Last updated

2025-10-13

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.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 7.BMI

Exclusion criteria

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 9.BMI > 40 10.Patients participating / participated in another clinical drug study within 3 months before recruitment.

Design outcomes

Primary

Measure	Time frame
To evaluate the effect of Phalatrikadi Guggul on 1.Biochemical tests : Lipid profile, LFTs, Sr. Insulin, BSL random. 2.Radiological : USG abdomen. Timepoint: Inclusion 30th day 60th day	—

Secondary

Measure	Time frame
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. 2.Radiological : USG abdomen. Timepoint: Inclusion 30th day 60th day	—

Countries

India

Contacts

Public ContactDr Vijayalaxmi Sujay Patil

PDEAs College of Ayurved and Research Centre Nigdi Pune

medhamaheshjoshi@gmail.com9881465798

Outcome results