Management of Non-Alcholic Fatty Liver Disease.

Efficacy of Siravedha along with Life Style Modification in the Management of Yakriddaalyudara (Non-Alcoholic Fatty Liver Disease)-An Open Labelled Randomized Standard Controlled Clinical Trial.

Status

Active, not recruiting

Phases

Phase 3

Study type

Interventional

Source

CTRI

Registry ID

CTRI/2023/05/053015

Enrollment

Registered

2023-05-22

Start date

Unknown

Completion date

Unknown

Last updated

2023-05-29

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

Conditions

Health Condition 1: K77- Liver disorders in diseases classified elsewhere

Interventions

None listed

Eligibility

Inclusion criteria

Inclusion criteria: 1. Patients will be diagnosed on the basis of following signs and symptoms: Dyspepsia, Nausea, Malaise, Fatigue, feeling of fullness in the abdomen, Generalized weakness, Upper abdominal pain and discomfort. 2.With or without Blood â?? Elevated serum transaminases, Alkaline phosphatase. Deranged lipid profile- S. Cholesterol, S. Triglyceride, S. HDL, S. LDL, S. VLDL 3.Both newly detected and previously diagnosed cases of Non-Alcoholic Fatty Liver Disease. 4.USG findings suggestive of fatty liver grade I & II. 5.Patients of Yakriddaalyudara (Non-Alcoholic Fatty Liver Disease) with controlled blood pressure ( >140/90 mm of hg) & Diabetic Mellitus (RBS 90-140 mg/dl).

Exclusion criteria

Exclusion criteria: 1.Patient aged below 20 years and above 60 years, pregnant women. 2.Patients with uncontrolled Diabetes or Hypertension, Patients with complications of Metabolic syndrome like Cerebrovascular accident (CVA), Myocardial Infarction (MI), chronic kidney disease (CKD). 3.Patients suffering from GB stone or obstructive jaundice 4.Patients consuming Hepatotoxic medicines, Alcohol or other Narcotic substances. 5.Patients suffering from Cirrhosis, Ascites, variceal hemorrhage, Coagulopathy, Hepato-Renal Syndrome. 6.Patients having history of Viral hepatitis (HbsAg, HCV), Auto-immune liver diseases (Primary biliary cirrhosis, primary sclerosing cholangitis, autoimmune hepatitis), Metabolic disorders (Wilsonâ??s disease, haemochromatosis), congenital blood diseases (sickle cell disease, thalassemia, G6PD deficiency anemia etc.) 7.Patients suffering from HIV, TB other infectious diseases, Malignancies, major psychiatric problems or any other serious illnesses. 8.Hb%

Design outcomes

Primary

Measure	Time frame
Relief in symptoms like Dyspepsia, Nausea, Malaise, Fatigue, the feeling of fullness in the abdomen, Generalized weakness, Upper abdominal pain, and discomfort.Timepoint: 2 Week	—

Secondary

Measure	Time frame
Symptomatic relief like Dyspepsia, Nausea, Malaise, Fatigue, feeling of fullness in the abdomen, Generalized weakness, Upper abdominal pain and discomfort. 2.laboratory parameter change like Liver Profile direct bilirubin and total bilirubin, S. Protein, S. Albumin, Albumin/Globulin ratio, SGOT, SGPT, S. Alkaline phosphatase, lipid profile- S. Cholesterol, S. Triglyceride, S. HDL, S. LDL, S. VLDL 4.USG findingsTimepoint: Day 0 and Day 30	—

Measure

Time frame

Symptomatic relief like Dyspepsia, Nausea, Malaise, Fatigue, feeling of fullness in the abdomen, Generalized weakness, Upper abdominal pain and discomfort. 2.laboratory parameter change like Liver Profile direct bilirubin and total bilirubin, S. Protein, S. Albumin, Albumin/Globulin ratio, SGOT, SGPT, S. Alkaline phosphatase, lipid profile- S. Cholesterol, S. Triglyceride, S. HDL, S. LDL, S. VLDL 4.USG findingsTimepoint: Day 0 and Day 30

—

Countries

India

Contacts

Public ContactDR T S DUDHAMAL

ITRA

DRTSDUDHAMAL@GMAIL.COM9428671939

Outcome results