CTRI/2023/05/052356
Recruiting
Phase 2
Randomized controlled clinical trial to compare the efficacy of Phalatrikadi Guggul with tablet Rosuvastatin in Medodushti with special reference to Nonalcoholic Fatty Liver Disease - NI
Dr Vijayalaxmi Sujay patil0 sites0 target enrollmentTBD
Overview
- Phase
- Phase 2
- Intervention
- Not specified
- Conditions
- Health Condition 1: K760- Fatty (change of) liver, not elsewhere classified
- Sponsor
- Dr Vijayalaxmi Sujay patil
- Status
- Recruiting
- Last Updated
- last year
Overview
Brief Summary
No summary available.
Investigators
Eligibility 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 \< 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.
Outcomes
Primary Outcomes
Not specified
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