A clinical study to evaluate the efficacy of Navanga Kwath with Vitamin E in the management of Non-Alcoholic Fatty Liver Disease(Yakritroga)

Phase 2

Conditions: Health Condition 1: K760- Fatty (change of) liver, not elsewhere classified

Registration Number: CTRI/2024/07/070820

Lead Sponsor: INSTITUTE FOR AYURVED STUDIES AND RESEARCH

Brief Summary: Not available

Detailed Description: Not available

Recruitment & Eligibility

Status: ot Yet Recruiting

Sex: Not specified

Target Recruitment: 0

Inclusion Criteria

1. The patient presented with cardinal features of Yakritroga as described in Ayurvedic

texts.

2. Randomly selected irrespective of their caste, religion and sex.

3. Patient with the age group of age of 25-60 years.

4. Voluntary agreement & and enrolment to participate in the study.

5. The ratio of AST/ALT below 2.

6. Non-alcoholic Fatty Liver Disease patient who was diagnosed by abdomen ultrasonic

examination and non-drinker or total abstainer or with alcohol intake of less than 20 gm

per day for females and less than 30 gm per day for males.

7. NAFLD confirmed by USG with or without having symptoms like fatigue and mild

discomfort in the upper quadrant of the abdomen.

8. Both freshly detected & and previously diagnosed cases of NAFLD.

Exclusion Criteria

1 Patient below 25 years and above 60 years of age

2 The ratio of AST or ALT over 2

3 Metabolic syndromes such as Type I and II Diabetes Mellitus Hypertension

Cerebrovascular Accident Myocardial Infarction and Chronic Kidney Disease

4 Any dysfunction of the liver besides Non Alcoholic Fatty Liver Diseases like Viral Hepatitis Liver Parenchymal Disease Ascites portal Hypertension Hepato Cellular Carcinoma Auto Immune Hepatitis Primary Biliary Cirrhosis Wilsons Disease and liver Transplantation or any other conditions interfering with the result of the treatment of non alcoholic fatty liver disease patient

5. Prior treatment with any medicine that affects the treatment of Non Alcoholic Fatty Liver Disease within 3 months

6 Patient suffering from HIV TB other infectious diseases Malignancies Major

Psychiatric Problems or any other serious problems

7. Patient on prolonged (more than 6 weeks) medication with corticosteroids antidepressants anti cholinergic hepatotoxic medicines or any other drug that may influence the outcome of The study

8 Alcoholics and any other drug abusers

9 Pregnant and Lactating women

10 The patient has a history of Hypersensitivity to the trial drug or any of its ingredients

Study & Design

Study Type: Interventional

Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Reduction in scoring pattern of sign and symptoms such as Tastelessness, Indigestion, Mild pain in the upper abdomen, Feeling of heaviness, Diminution of the agni, Feeling of nausea and vomiting, FatigueTimepoint: 42 days

Secondary Outcome Measures