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Clinical Trials/CTRI/2023/05/052356
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.

Registry
who.int
Start Date
TBD
End Date
TBD
Last Updated
last year
Study Type
Interventional

Investigators

Sponsor
Dr Vijayalaxmi Sujay patil

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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