A Study to Test if Liver Detox Formula is Safe and Works for Treating Patients with Fatty Liver Disease

An Open-Label Study To Evaluate The Safety And Efficacy Of Liver Detox Formula In Fatty Liver Disease - Nil

Status

Active, not recruiting

Phases

Phase 3

Study type

Interventional

Source

CTRI

Registry ID

CTRI/2024/12/077731

Enrollment

Registered

2024-12-06

Start date

Unknown

Completion date

Unknown

Last updated

2025-06-24

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

Conditions

Health Condition 1: K700- Alcoholic fatty liver Health Condition 2: K760- Fatty (change of) liver, not elsewhere classified

Interventions

None listed

Eligibility

Inclusion criteria

Inclusion criteria: 1. Diagnosis - Patients already diagnosed with Alcoholic Fatty Liver Disease (AFLD) or Non-Alcoholic Fatty Liver Disease (NAFLD) confirmed through clinical evaluation (e.g., imaging or medical history). 2. Willingness to Participate - Participants must be willing and able to provide written informed consent and comply with the study requirements, including completing all scheduled visits and questionnaires. 3. Stable Medical Condition - Participants should have a stable medical condition that would not interfere with the study treatment or outcome evaluations.

Exclusion criteria

Exclusion criteria: 1. Severe Liver Disease - Patients with severe liver diseases, such as cirrhosis, hepatic failure, or hepatocellular carcinoma. 2. Pregnancy or Breastfeeding - Pregnant or breastfeeding women. 3. Other Liver Conditions - Patients diagnosed with liver conditions unrelated to fatty liver disease, including but not limited to Hepatitis B, Hepatitis C, or HIV. 4.Use of Other Investigational Drugs - Participants currently enrolled in another clinical study or using investigational drugs within 30 days prior to screening. 5. Severe Comorbidities - Patients with severe comorbid conditions such as uncontrolled cardiovascular, renal, or hematological diseases that could interfere with the study results or pose an increased risk to the patient. 6. Substance Abuse - Patients with a history of substance abuse (other than alcohol) or any medical condition that could affect compliance with the study protocol. 7. Non-compliance - Patients unable or unwilling to comply with study procedures, including attending follow-up visits or completing questionnaires.

Design outcomes

Primary

Measure	Time frame
1. Chronic Liver Disease Questionnaire (CLDQ) 2. Fatigue Severity Scale (FSS)Timepoint: Day 0, Day 30, Day 60 and Day 90	—

Secondary

Measure	Time frame
1. Improvement in Liver-Related Symptoms 2. Patient Satisfaction 3. Safety and Tolerability 4. Clinician-Assessed Symptom Improvement 5. Clinician Disease Severity AssessmentTimepoint: Day 0, Day 30, Day 60 and Day 90.	—

Countries

India

Contacts

Public ContactMs Arpita Malgi

Planet Ayurveda Private Limited

trade@planetayurveda.com8578888111

Outcome results