Effect of Ayurvedic drug formulation on liver health

A randomized, double-blind clinical study to assess efficacy and safety of polyherbal formulation in non-alcoholic fatty liver patients. - NIL

Status

Active, not recruiting

Phases

Phase 3

Study type

Interventional

Source

CTRI

Registry ID

CTRI/2025/04/084033

Enrollment

Registered

2025-04-03

Start date

Unknown

Completion date

Unknown

Last updated

2025-04-28

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Health Condition 1: K759- Inflammatory liver disease, unspecified

Interventions

None listed

Eligibility

Inclusion criteria

Inclusion criteria: 1.Diagnosis of hepatic disorder with abnormal LFT with or without signs and symptoms such as dark-colored urine, light-colored stools, pruritus, pruritic red hives, fever, nausea, vomiting, anorexia, and right upper abdominal discomfort, pain or feeling of pressure. 3.Subjects willing to sign inform consent form.

Exclusion criteria

Exclusion criteria: 1. Other causes of liver disease including evidence of chronic viral hepatitis (Hepatitis B or C) and biliary obstruction 2. AST &gt more than 500 U/L or ALT &gt more than 300 U/L 3. Suspected hypersensitivity to contents of study drug 4. Advanced liver disease (e.g. ascites, bleeding esophageal varices and hepatic encephalopathy, hepatic cancer) 5. Subjects with serious illness, e.g., uncontrolled diabetes, multisystem failure, HIV, cancer, severe renal insufficiency, serious cardiovascular disease and patients with history of gastritis, peptic ulcer, bleeding ulcer 6. Patients with a renal failure 7. Pregnant or lactating women 8. Subjects with moderate to high physical activity having energy expenditure of 3.5 to 7 kcal/min 9. Other conditions, which in the opinion of the investigators, make the patient unsuitable for enrollment or could interfere with his/her participation in, and completion of the protocol

Design outcomes

Primary

Measure	Time frame
Assessment of changes in serum total bilirubin, AST and ALTTimepoint: baseline to 12 weeks.	—

Secondary

Measure	Time frame
Assessment of change in symptoms of liver disease like anorexia, fatigue, abdominal pain, and nausea.Timepoint: baseline to 12 weeks.;Adverse events profileTimepoint: baseline to 12 weeks.;Compliance and tolerability of the product throughout the study .Timepoint: baseline to 12 weeks.	—

Countries

India

Contacts

Public ContactDr Kshipra Rajoria

National Institute of Ayurveda Jaipur

sarveshksingh21@gmail.com08739860237

Outcome results