Health Condition 1: K760- Fatty (change of) liver, not elsewhere classified Health Condition 2: K758- Other specified inflammatory liverdiseases
Conditions
Interventions
None listed
Sponsors
AMAI CHARITABLE TRUST PUNE
Eligibility
Inclusion criteria
Inclusion criteria: b)Patients with diabetes and hyperlipidemia as co-morbid conditions c)NAFLD patients who are refractive to standard drugs of treatment d Disease or condition that does not respond to treatment. e) Criteria for selection: f)Eligibility based on liver fat: g) Has liver fat (as measured by PDFF via MRI) � 18 percent at Screening. This MRI-PDFF data will be considered as a baseline value for eligible patients. h)Prior to undergo MRI-PDFF in screening, the patient will be first pre-screened based on the following criteria: i)Previously diagnosed with moderate to severe fatty liver based on ultrasound/CT OR liver fat more than 20 percent on MRI PDFF OR liver fat 33 percent via biopsy within past six months. j)If diagnosis is between 3 and 6 months prior to screening, an ultrasound (positive for moderate to severe fatty liver) is required prior to the baseline MRI-PDFF k)For new patients who do not have liver fat diagnosis within past six months, these patients will be first pre-screened with USG for moderate to severe fatty liver and then screened with MRI-PDFF. This MRI-PDFF data will be considered as baseline value for eligible patients OR l)(ii) If MRI PDFF is between more than or equal to 15 & less than 18 percent at baseline, the following (minimum 2 criteria) has to be fulfilled m) Has ALT levels more than 30 U/L for men, less than 19 U/L for women n) Has a BMI between 25kg/m2 and 40 kg/m2? o) Has an HbA1c test result of more than 5.7 percent less than or equal to 7 percent in the last 3 months p) Willing to come for regular follow -up visits q) Able to give written informed consent r) Disease or condition that does not respond to treatment.
Exclusion criteria
Exclusion criteria: a)Known history of hypersensitivity to herbal extracts or dietary supplements. b)Duration of jaundice greater than 3 months, steatohepatitis, advanced fibrosis, cirrhosis, and other liver diseases c)Pregnant women, lactating women and women of childbearing potential not following adequate contraceptive measure, women who were found positive for urine pregnancy test. d)Patients who are on immunomodulatory drugs e)Ongoing treatment with herbals or allopathic hepato-protective drugs f)Evidence of several renal, hepatic or hemopoietic disease or severe cardiac insufficiency as revealed by laboratory investigations. g)History of having received any investigational drug or participated in any other clinical trial which ended in preceding month or currently ongoing. h)Ayurvedic formulation or any form of Complimentary Alternative Medicine therapy in the preceding 2 months I)Any condition that in the opinion of the investigator does not justify the patients inclusion for the study. j)Patients who underwent liver transplantation
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Change in Complete liver profile (Total Bilirubin, Direct Bilirubin, ALP, SGPT and SGOT) ââ?¬Â¢Anti-oxidant enzymes-MDA, SOD, Catalase, Reduced Glutathione (GSH), Glutathione Peroxidase (GPx),Hematology for immuno-stimulation (Hb, PCV, WBC -DLC, MCV, MCH, MCHC, MPV),Lipid Profile -LDL, HDL, TC, TG,Complete Blood Chemistry CBC - including fasting glucose, glycosylated Haemoglobin. Timepoint: Change in the laboratory parameters from baseline to last study visit (Day 90). | — |
Secondary
| Measure | Time frame |
|---|---|
| Changes in MRI,USG & liver function testsTimepoint: 1.change in MRI from Day 0 to Day 90 2.change in Ultrasound from Day 0 to Day 90 3.change in Liver function tests from Day 0 to end Day 90 4.change in hyperlipidemia and anti-hyperglycemic properties of Ayurvedic formulation extracts at day 90 | — |
Countries
India
Contacts
Public ContactPranjal Ausekar
ACE Hospital - and Shripad medi-search Pvt. Ltd, Pune
Outcome results
None listed