Health Condition 1: K758- Other specified inflammatory liverdiseases
Conditions
Interventions
Intervention1: Sesame extract -
S3 complex: Each capsule containing
Sesame extract - S3
complex 75 mg to be
taken once daily
immediately after
breakfast, Duration 90 days
Intervention2: Sesame e
Sponsors
M/s.Ingex Botanicals Pvt Ltd
Bio Actives Japan KK
Eligibility
Inclusion criteria
Inclusion criteria: 1. Adults aged between 20 to 65 years of either sex with USG findings suggestive of NonAlcoholic Fatty Liver Disease grade I II and III. 2. BMI 25 to 35 kg per m2 3. Newly onset Diabetes mellitus (not more than 10 years) 4. Newly onset Hypertension (not more than 10 years) 5. Lipid profile a. Lower HDL level b. Higher LDL Triglyceride TC level 6. Liver function test AST or ALT (within more than 3 times of the upper limit of normal range) 7. Willing to participate in the study with a signed and dated written consent. 8. Able to comply with all required study procedures and schedule. 9. Able to comply and willing to follow the prescribed diet plan.
Exclusion criteria
Exclusion criteria: 1. Alcoholic and smoking. 2. Bariatric surgery within the last year. 3. Surgery within the last six months. 4. Severe cerebrovascular disease (cerebral infarction and cerebral hemorrhage) heart disease (angina pectoris myocardial infarction heart failure and arrhythmia requiring treatment) or malignant tumours within the last six months. 5. Taking drugs that affect body weight (fat absorption inhibitors appetite suppressants health food or supplements related to obesity psychiatric drugs betablockers diuretics contraceptives steroids and female hormones) within the last month. 6. Obese or overweight due to endocrine diseases (hypothyroidism Cushings syndrome). 7. Maintenance treatment acute and chronic for gastrointestinal disorders (gastric ulcer chronic digestive disorder irritable bowel syndrome). 8. Psychologically significant medical history or current disease (schizophrenia epilepsy anorexia bulimia) or a history of alcohol and other drug abuse. 9. Malabsorption syndrome autoimmune disease. 10. Participation in a commercial obesity program or obesity clinical trial within the last three or six months respectively. 11. Pregnancy lactation or planning to become pregnant during the study period. 12. Women not using a correct contraceptive method. 13. Allergic reaction to the study drug or herbal extractsdietary supplements. 14. Duration of jaundice greater than 3 months steatohepatitis advanced fibrosis cirrhosis viral hepatitis or other liver diseases. 15. Patients on immunomodulatory drugs coronary artery disease treatment or hepatoprotective drugs. 16. Treatment of NAFLD for at least three months prior to screening. 17. Receipt of any investigational drug or participation in another clinical trial within the preceding month. 18. Liver transplantation. 19. Use of Ayurvedic formulation or Complementary Alternative Medicine (CAM) therapy within the preceding two months. 20. Any condition that in the investigators opinion does not justify the patients inclusion for the study.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Primary Outcomes: 1.Change in Percentage of patients who show improvement in liver Ultrasonography evaluation as compared to screening visit (Degree of fatty infiltration, Hepatomegaly or hyper echoic shadow or resolution of Ascites) from baseline to day 90 2.Change in Hepatic Steatosis index form baseline to day 90 3. Change in DEXA Scan form Day 0 to day 90 4.Change in Quality-of-Life Questionnaires (CLDQ) from baseline to Day 30, 60 and 90. 5.Change in BMI from baseline to Day 90. 6.Change in Body fat from baseline to Day 90.Timepoint: Screening visit, day 0, day 30,day 60, day 90. | — |
Secondary
| Measure | Time frame |
|---|---|
| Secondary Outcomes: 1.Change in Liver function parameters (AST, ALT, GGT and Total bilirubin, direct and indirect bilirubin, albumin and globulin) from baseline to Day 30, 60 and 90 2.Change in Lipid profile (LDL, HDL, TC, TG) from baseline to Day 30, 60 and 90. 3.Change in Comparative evaluation of Anti-oxidant enzymes (Superoxide dismutase, Catalase, Glutathione peroxidase) and MDA from baseline to Day 30, 60 and 90. 4.Change in TNF-alpha & IL-6 from baseline to Day 30, 60 and 90 5.Change in Leptin & Adiponectin form baseline to day 90 6.Change in Glycosylated Hemoglobin (HbA1C) form baseline to day 90.Timepoint: Screening visit, day 30,day 60, day 90. | — |
Countries
India
Contacts
Public ContactDr Ashok Godavarthi
Radiant Research Services Pvt Ltd
Outcome results
None listed