To evaluate the Safety and efficacy of an extract of Ayurvedic formulation Capsules in adult patients suffering from Non-Alcoholic Fatty Liver Disease (NAFLD) with associated metabolic syndromes.
- Conditions
- Health Condition 1: K760- Fatty (change of) liver, not elsewhere classifiedHealth Condition 2: K758- Other specified inflammatory liverdiseases
- Registration Number
- CTRI/2021/09/036340
- Lead Sponsor
- AMAI CHARITABLE TRUST PUNE
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Completed
- Sex
- Not specified
- Target Recruitment
- 82
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.
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
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method
- Secondary Outcome Measures
Name Time Method