To evaluate safety/tolerability and the efficacy of Supplement to improve function of liver in subjects with Non-Alcoholic Fatty Liver Disease (NAFLD).
- Conditions
- Other specified diseases of liver,
- Registration Number
- CTRI/2022/12/048588
- Lead Sponsor
- Sundyota Numandis Probioceuticals Pvt. Ltd.
- Brief Summary
This study will be conducted to evaluate the safety/tolerability and the efficacy of Amino Acid Supplementation to improve liver function in subjects with Non-Alcoholic Fatty Liver Disease (NAFLD). Sufficient number of subjects will be enrolled in the study to get 100 evaluable subjects. Subjects who meet all inclusion criteria and none of the exclusion criteria based on medical history will be recruited in the study. Subject’s visit 1 will be screening visit. Follow up visit 2 will be on 28 ± 2 days, Follow up visit 3 will be on 56 ± 2 days and end of study visit will be on 84 ± 2 days. Subjects will be screened for the eligibility criteria during screening visit.
Subjects will be instructed to mix the sachets containing powder (approx. 6 gm) with 150-200 ml water for oral intake three times a day. The subjects will be divided into 5 groups and in each arm 22 subjects will be enrolled. Arm 1: 3 Placebo Sachets, Arm 2: Supplement Mix- 1 sachet + 2 Placebo sachets, Arm 3: Supplement Mix- 2 sachets + 1 Placebo sachet, Arm 4: Supplement Mix- 3 sachets, Arm 5: Comparator supplement Mix 2 sachets + 1 Placebo sachet. Primary endpoint will be change in Fatty Liver Index and Liver Stiffness (USG-Liver) from baseline and at the end of study. The secondary endpoint will be change in GSG Index (Glutamate serine glycine), QUICKI Index, weight, BMI, laboratory parameters, quality of Life, HOMA-IR will be checked from baseline and at the end of study.
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Completed
- Sex
- All
- Target Recruitment
- 110
- Male or female subjects between 20-50 years of age (both inclusive) with Non-Alcoholic fatty Liver Disease (Grade I & II).
- Subject has provided written, signed and dated informed consent to participate in the study.
- Subject is willing and able to comply with the protocol.
- Subject is participating in another clinical trial or has received an investigational product within thirty days prior to enrollment.
- Subject has a history of alcohol or other drug abuse in the past year.
- Subject has a known allergy or sensitivity to any ingredient in the test product.
- 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.
- Investigator is uncertain about subject’s capability or willingness to comply with the protocol requirements.
- 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).
- 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.
- 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.
- Diseases, eczema, skin diseases/ allergy.
- 11.Malnutrition 12.
- Severe renal, cardiac or respiratory insufficiency.
- 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.
- Pharmacological treatment with some potential benefit on NAFL including ursodeoxycholic acid, vitamin E, betaine, pioglitazone, rosiglitazone, metformin, pentoxifylline or gemfibrozil.
- Fasting glucose levels greater than 250 mg per deciliter (13.3 mmol per liter).
- Contraindication to liver biopsy.
- Concomitant disease with reduced life expectancy.
- Severe psychiatric conditions.
- Pregnant and breast feeding women.
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method 1) Change in Fatty Liver Index Baseline and 84 days 2) Change in Liver Stiffness (USG-Liver) Baseline and 84 days
- Secondary Outcome Measures
Name Time Method 1) Incidence and Number of AEs and SAEs. Baseline and 84 days 2) Change in GSG Index (Glutamate serine glycine) Baseline and 84 days 3) Change in QUICKI Index Baseline and 84 days 4) Change in Weight Baseline and 84 days 5) Change in BMI Baseline and 84 days 6) Change in laboratory parameters from baseline Baseline and 84 days 7) Improvement in Quality of Life Baseline and 84 days 8) Change in HOMA-IR Baseline and 84 days 9) Changes in vital parameters Baseline and 84 days
Trial Locations
- Locations (1)
Shakti Super Specialty Hospital
🇮🇳Ahmadabad, GUJARAT, India
Shakti Super Specialty Hospital🇮🇳Ahmadabad, GUJARAT, IndiaDr Devendra GadhadraPrincipal investigator9374643422gadhadradevendra@gmail.com