Health Condition 1: K768- Other specified diseases of liver
Conditions
Interventions
Intervention1: Amino Acid Supplementation: Powdered sachet (approx. 6 gm) to be mixed with 150-200 ml
water for oral intake three times a day for 84 days.
Control Intervention1: Placebo: Powdered sa
Sponsors
Sundyota Numandis Probioceuticals Pvt. Ltd.
Cysbio ApS
Eligibility
Inclusion criteria
Inclusion criteria: 1. Male or female subjects between 20-50 years of age (both inclusive) with Non-Alcoholic fatty Liver Disease (Grade I & II). 2. Subject has provided written, signed and dated informed consent to participate in the study. 3. Subject is willing and able to comply with the protocol.
Exclusion criteria
Exclusion criteria: 1. Subject is participating in another clinical trial or has received an investigational product within thirty days prior to enrollment. 2. Subject has a history of alcohol or other drug abuse in the past year. 3. Subject has a known allergy or sensitivity to any ingredient in the test product. 4. Subject has any medical condition or uses any medication, nutritional product, dietary supplement or program, which in the opinion of the investigator, might interfere with the conduct of the study or place the subject at risk. 5. Investigator is uncertain about subjectâ??s capability or willingness to comply with the protocol requirements. 6. Presence of other form of liver diseases (viral or autoimmune hepatitis, drug-induced liver disease, metabolic and hereditary liver disease and alpha-1 antitrypsin deficiency). 7. Subjects with accidental cases like injury, all types of anemias. 8.Subjects with Hemophilia, Thalassemia, case of poisoning, alcoholic liver, Alcoholic chronic liver disease, Decompensated cirrhosis. 9. Chronic liver disease of different etiology (autoimmune disease, primary biliary cirrhosis, primary sclerosing cholangitis, hereditary hemochromatosis, Wilson disease, deficits of alpha-1 antitrypsin, celiac disease. 10. Diseases, eczema, skin diseases/ allergy. 11.Malnutrition 12. Severe renal, cardiac or respiratory insufficiency. 13. Malignant tumors 14. Presence of secondary cause of NAFL such as medications that induce steatosis (corticosteroids, estrogens, methotrexate, amiodarone, tamoxifen and calcium channel blockers) and gastrointestinal bypass surgery. 15. Pharmacological treatment with some potential benefit on NAFL including ursodeoxycholic acid, vitamin E, betaine, pioglitazone, rosiglitazone, metformin, pentoxifylline or gemfibrozil. 16. Fasting glucose levels greater than 250 mg per deciliter (13.3 mmol per liter). 17. Contraindication to liver biopsy. 18. Concomitant disease with reduced life expectancy. 19. Severe psychiatric conditions. 20. Pregnant and breast feeding women.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| 1) Change in Fatty Liver Index 2) Change in Liver Stiffness (USG-Liver)Timepoint: Baseline and 84 days | — |
Secondary
| Measure | Time frame |
|---|---|
| 1) Incidence and Number of AEs and SAEs.Timepoint: Baseline and 84 days;2) Change in GSG Index (Glutamate serine glycine)Timepoint: Baseline and 84 days;3) Change in QUICKI IndexTimepoint: Baseline and 84 days;4) Change in WeightTimepoint: Baseline and 84 days;5) Change in BMITimepoint: Baseline and 84 days;6) Change in laboratory parameters from baselineTimepoint: Baseline and 84 days;7) Improvement in Quality of LifeTimepoint: Baseline and 84 days;8) Change in HOMA-IRTimepoint: Baseline and 84 days;9) Changes in vital parametersTimepoint: Baseline and 84 days | — |
Countries
India
Contacts
Public ContactDr Milan Satia
Ethicare Clinical Trial Service
Outcome results
None listed