Health Condition 1: K760- Fatty (change of) liver, not elsewhere classified
Conditions
Interventions
Intervention1: Ayulite Capsule: Ayulite Capsules contains Andrographis paniculata, Tecomella undulate, Tephrosia purpurea, Phyllanthus niruri, Eclipta alba, Holarrhena antidysenterica, Glycyrrhiza gla
Sponsors
Welex Laboratories Pvt Ltd
Eligibility
Inclusion criteria
Inclusion criteria: 1. Subjects with grade 1 and 2 non-alcoholic fatty liver disease (NAFLD) diagnosed using ultrasonography 2. Subject is able and willing to undertake all study-required procedures and has the ability to take oral medications. 3. Subjects not having jaundice or any other symptom of active hepatitis
Exclusion criteria
Exclusion criteria: 1. Subjects with highly uncontrolled diabetes (HbA1c- 10.0 percent or greater) 2. Patients with chronic alcoholism 3. Patients who are known cases of other forms of liver disease, including Hepatitis B (positive serum hepatitis B surface antigen), hepatitis C (positive antiââ?¬â?? hepatitis C virus) 4. History of any other severe and long standing liver disorders 5. Cases of drug-induced liver disease on the basis of exposure and history 6. Cases with biliary duct obstruction on the basis of ultrasound 7. Patients with cirrhotic and pre cirrhotic condition and hepatocellular carcinoma diagnosed by USG abdomen 8. History of gastrointestinal bypass or use of drugs known to cause hepatic steatosis (e.g., amiodarone, valproate, tamoxifen, methotrexate, steroids etc.) 9. Active substance abuse 10. Pregnant or trying to become pregnant and lactating women 11. Suspected hypersensitivity to contents of Ayulite Capsule 12. Subjects with known serious illness, e.g., uncontrolled hypertension, multisystem failure, HIV, cancer, severe renal insufficiency, serious cardiovascular disease and patients with history of peptic ulcer, bleeding ulcer 13. Any other conditions, which in the opinion of the investigator/s, makes the patient unsuitable for enrollment or could interfere with his/her participation and completion of the study. 14. Subject currently participating /participated in any clinical trial for past 90 days
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Comparative changes in fatty liver stage (using Ultrasonography) between two groupsTimepoint: Day -3, Day 0, Day 30, Day 60, Day 90 | — |
Secondary
| Measure | Time frame |
|---|---|
| 1. Comparative changes in liver functions and Lipid profile. 2. Comparative change in glycosylated hemoglobin percentage 3. Comparative changes in fasting blood sugar, fasting serum insulin and HOMA IR and BMI 4. Comparative change in symptoms 5. Comparative change in global assessment for overall change Timepoint: Day -3, Day 0, Day 30, Day 60, Day 90 | — |
Countries
India
Contacts
Public ContactDr Sanjay Tamoli
Target Institute of Medical Education and Research
Outcome results
None listed