Clinical study on Ayulite Capsules on Nonalcoholic Fatty Liver Disease

Phase 2

Completed

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

• Registration Number: CTRI/2021/06/034244
• Lead Sponsor: Welex Laboratories Pvt Ltd

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Study Completion: 2022-01-07
• Last Update Posted: 17 October 2022

Recruitment & Eligibility

• Status: Completed
• Sex: Not specified
• Target Recruitment: 61

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

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

Study & Design

• Study Type: Interventional
• Study Design: Not specified