Safety and Efficacy of MOLEQURE-Liver Health in Liver Dysfunction

A Non-randomized, Open-Labelled Pilot Study to Assess the Safety and Efficacy of MOLEQURE-Liver Health in Adult Subjects with Mild to Moderate Liver Dysfunction - NIL

Status

Active, not recruiting

Phases

Phase 2

Study type

Interventional

Source

CTRI

Registry ID

CTRI/2025/10/095545

Enrollment

Registered

2025-10-01

Start date

Unknown

Completion date

Unknown

Last updated

2025-10-13

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

Conditions

Health Condition 1: K77- Liver disorders in diseases classified elsewhere

Interventions

None listed

Eligibility

Inclusion criteria

Inclusion criteria: 1. Male and female volunteers aged 18-60 years. 2. Subjects with elevated alanine aminotransferase (ALT) or aspartate aminotransferase (AST) (1x upper limit of normal or 1.5x upper limit of normal). 3. Subjects with liver dysfunction symptoms (e.g., abdominal pain, fatigue, loss of appetite, right upper quadrant discomfort). 4. Willingness to comply with study procedures and provide written informed consent.

Exclusion criteria

Exclusion criteria: 1. Known diagnosis of decompensated liver disease, including but not limited to ascites, hepatic encephalopathy, or variceal bleeding. 2. History of Hepatitis B virus (HBV), Hepatitis C virus (HCV), or HIV infection. 3. Use of any medications, supplements, or herbal products specifically intended for the treatment or management of liver disorders within the last 30 days. 4. History of significant alcohol consumption, defined as above 60 ml of alcohol per day. 5. Presence of severe renal impairment, congestive heart failure, or significant psychiatric disorders that, in the investigator s opinion, could interfere with study participation. 6. Pregnant or lactating women, or women planning to become pregnant during the study period. 7. Participation in any other clinical trial within 30 days prior to the screening visit. 8. Known hypersensitivity or allergy to any component of the study intervention.

Design outcomes

Primary

Measure	Time frame
Reduction in liver function biomarkers (ALT, AST, ALP, and bilirubin) throughout the study periodTimepoint: 12 weeks	—

Secondary

Measure	Time frame
Change in quality of life (QoL) from baseline as measured by 5-item World Health Organization Well-Being Index (WHO-5).Timepoint: 12 weeks	—

Countries

India

Contacts

Public ContactSrikanta Pandit

J. B. Roy State Ayurvedic Medical College and Hospital

srikantapandit@gmail.com9831723650

Outcome results