CTRI/2022/03/041481
Active, not recruiting
Phase 3
A Prospective, Randomized, Double-Blind, Two-arm, Placebo-Controlled Comparative Clinical Study To Evaluate The Efficacy And Safety of Liv.52 DS tablets in Metabolic dysfunction-Associated Fatty Liver Disease (MAFLD): An Exploratory Study. - MAFLD
Overview
- Phase
- Phase 3
- Intervention
- Not specified
- Conditions
- Health Condition 1: E70-E88- Metabolic disorders
- Sponsor
- Himalaya Wellness Company
- Status
- Active, not recruiting
- Last Updated
- 2 years ago
Overview
Brief Summary
No summary available.
Investigators
Eligibility Criteria
Inclusion Criteria
- •Adult male and female subjects aged between \=18 and \=65 years.
- •Subjects who are clinically diagnosed with Metabolic dysfunction\-associated Fatty Liver Disease (MAFLD) defined as Hepatic Steatosis in adults (detected either by imaging techniques, blood biomarkers/scores or by liver histology) in addition to one of the following criterias, namely,
- •A. Overweight or obesity (defined as BMI \=25 kg/m2 in Caucasians or BMI \=23 kg/m2 in Asians)
- •B. Type 2 Diabetes Mellitus C. Lean or normal weight (defined as BMI \<25 kg/m2 in Caucasians or BMI \<23 kg/m2 in Asians) with the presence of at least 2 metabolic risk abnormalities from the listed below,
- •Waist circumference \=102/88 cm in Caucasian men and women or \=90/80 cm in Asian men and women
- •Blood pressure \=130/85 mmHg or specific drug treatment
- •Plasma triglycerides \=150 mg/dl (\=1\.70 mmol/L) or specific drug treatment Plasma HDL\-cholesterol \<40 mg/dl ( \<1\.0 mmol/L) for men and \<50 mg/dl ( \<1\.3 mmol/L) for Women or specific drug treatment o Prediabetes (i.e., fasting glucose levels 100 to 125 mg/dl \[5\.6 to 6\.9 mmol/L], or 2\-hour post\-load Glucose levels 140 to 199 mg/dl \[7\.8 to 11\.0 mmol] or HbA1c 5\.7% to 6\.4% \[39 to 47 mmol/mol])
- •Homeostasis model assessment of insulin resistance score \=2\.5 o Plasma high\-sensitivity C\-reactive protein level \>2 mg/L 3\. Non\-invasive FIBROSCAN confirmed hepatic steatosis and stiffness as defined by,
- •Liver Stiffness Measurement score of \=6\.2 to \= 9\.8 Kpa from Vibration Controlled Transient Elastography (VCTE)
- •Any grade of steatosis (S1\-S3\) from Continuous Attenuation Parameter (CAP)
Exclusion Criteria
- •FIBROSCAN confirmed LSM score \> 9\.8kpa (F3\-F4\) confirmed through VCTE.
- •History of histologic confirmed MAFLD with advanced fibrosis (stage 3, 4\).
- •History of Cirrhosis or its complications(like HCC, Portal HTN, Liver failure).
- •Complications may involve:
- •Patients listed for living\-related or orthotopic liver transplantation
- •Patients with a history of hepatocellular carcinoma (HCC) or history of HCC treatment.
- •Evidence of portal hypertension (e.g., low Platelet counts,
- •esophageal varices, ascites, history of hepatic encephalopathy, splenomegaly)
- •(Radiologic imaging consistent with cirrhosis or portal hypertension would also be excluded)
- •Other cause of Steatosis (Hep\-C, Wilson Disease, Medications, Severe malnutrition).
Outcomes
Primary Outcomes
Not specified
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