Health Condition 1: E70-E88- Metabolic disorders
Conditions
Interventions
None listed
Sponsors
Himalaya Wellness Company
Eligibility
Inclusion 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 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 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) AST value of >1.5 times the Upper Limit of the Normal. ALT = 1.5 times the Upper Limit of the Normal. 5. Female must be either of non-child bearing potential (surgically sterilized at least 6 months prior to screening or postmenopausal) or using one or more methods of contraception and non-lactating. Subjects willing to sign informed consent.
Exclusion criteria
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). Subjects diagnosed as “Alcoholic Liver Disease (ALD) ? on the basis of all of the following criteria: Patient with a history of alcohol abuse based on AUDIT questionnaire (A total sum of >8 for men and >4 for women) Active alcohol use until 4 weeks prior to screening Patients with elevated liver function test of ALT and AST >1.5 times of upper limit of normal. Ultrasound evidence Alcoholic fatty liver and / or Alcoholic Hepatitis Alcohol Liver disease. Maddrey Discriminant function (DF) less than 32. History of other co-existing Chronic Liver Diseases (such as Chronic Viral hepatitis, Hemochromatosis, Autoimmune Liver Disease, DILI, Alpha-1 Anti-trypsin Deficiency etc). Subjects with history of myopathies or evidence of active muscle diseases. Evidence of poorly-controlled diabetes [glycosylated haemoglobin (HbA1c) > 9%]. Subject with the history of type I diabetes mellitus. Other Laboratory Screening Results: • Total white blood cells (WBC) • Absolute neutrophil count (ANC) • Platelet count • Prothrombin time > 1.2 INR • Creatine kinase above the upper limit of normal (ULN) except when in relation with intense exercise. • Serum creatinine >2 mg/dL or creatinine clearance Subject on fibrates (Other drugs for dyslipidaemia will be allowed provided dose is stable in last 6 months). Use of drugs associated with a clinical or histological picture consistent with fatty liver disease or MAFLD for more than12 consecutive weeks in the 1 year prior to start of the study; (these include amiodarone, tamoxifen, methotrexate, glucocorticoids, anabolic steroids, tetracyclines, estrogens, valproate/valproic acid, chloroquine, anti-HIV drugs etc.). Subjects with uncontrolled clinically significant serious conditions like severe anemia, severe cardiovascular disease, respiratory, hepatic, neurological, psychiatric, or malignancy/bleeding disorder or other major systemic disease or patients with short life expectancy that, according to the Investigator, will preclude their safe participation in this study, or will make implementation of the protocol or interpretation of the study results difficult. History of bariatric surgery within 1 year or planned Bariatric surgery. Known history of drug abuse/dependency that would limit ability to comprehend or follow instructions related to informed consent, treatment instructions, study procedures or follow-up guidelines. Known allergy, sensitivity or intolerance to the study drugs or their
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| 1. Improvement in FAST Score as compared to Placebo group 2. Change in Liver Stiffness Measurement (LSM) Score through VCTE, CAP (steatosis) and AST value as assessed through FAST Score. 3. Change in AST to Platelet Ratio Index (APRI) 4. Change in Fib- 4 index. 5. Change in NAFLD Fibrosis Score (NFS) 6. Mean percentage change in other parameters of Liver function test 7. Mean percentage change in parameters of Lipid profile and lipoprotein 8. Mean percentage change in fasting glucose and Hb1AcTimepoint: 6 months | — |
Secondary
| Measure | Time frame |
|---|---|
| 1. Assessment of quality of life/clinical assessments 2. Incidence of adverse events.Timepoint: 6 months | — |
Countries
India
Contacts
Public ContactKavitha Rangaiah
Himalaya Wellness Company
Outcome results
None listed