To evaluate safety/tolerability and the efficacy of Supplement to improve function of liver in subjects with Non-Alcoholic Fatty Liver Disease (NAFLD).
- Conditions
- Health Condition 1: K768- Other specified diseases of liver
- Registration Number
- CTRI/2022/12/048588
- Lead Sponsor
- Sundyota Numandis Probioceuticals Pvt. Ltd.
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Completed
- Sex
- Not specified
- Target Recruitment
- 103
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.
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.
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method
- Secondary Outcome Measures
Name Time Method