Study on the Safety and Effectiveness of Liver Health Powder for Fatty Liver

An Open-Label, Single Arm, Single Centered Clinical Study To Evaluate The Safety And Efficacy Of Yakrit Plihantak Churna In Subjects With Fatty Liver - Nil

Status

Active, not recruiting

Phases

Phase 3

Study type

Interventional

Source

CTRI

Registry ID

CTRI/2024/12/078163

Enrollment

Registered

2024-12-16

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. Adults aged 18-65 years with ultrasonography-confirmed fatty liver disease (either alcoholic or non-alcoholic). 2. Willing and able to provide written informed consent. 3. No significant comorbidities affecting liver function or overall health.

Exclusion criteria

Exclusion criteria: 1. Pregnant or lactating women. 2. HIV, Hepatitis B, or Hepatitis C positive individuals. 3. Use of investigational drugs within 1 month prior to study enrollment. 4. Presence of severe cardiovascular, renal, or mental health conditions.

Design outcomes

Primary

Measure	Time frame
1. Improvement in Quality of Life (QoL): The primary efficacy endpoint will be the improvement in quality of life (QoL) in patients with fatty liver disease, as measured by the Chronic Liver Disease Questionnaire (CLDQ). Changes in CLDQ scores from baseline to Day 90 will assess the product’s impact on patients’ liver disease-specific quality of life.Timepoint: Day 1, Day 30, Day 60, Day 90	—

Secondary

Measure	Time frame
1. Reduction in Fatigue: Assessed using the Fatigue Severity Scale (FSS), measuring fatigue reduction from baseline to Day 90. 2. Reduction in Liver-Related Symptoms: Evaluated using the Liver Disease Symptom Index 2.0 (LDSI 2.0), tracking changes in symptoms like abdominal discomfort and nausea from baseline to Day 90. 3. Improvement in General Well-Being: Measured through the General Well-Being Schedule (GWBS), comparing emotional and physical well-being scores from baseline to Day 90.Timepoint: Day 1, Day 30, Day 60, Day 90	—

Measure

Time frame

1. Reduction in Fatigue: Assessed using the Fatigue Severity Scale (FSS), measuring fatigue reduction from baseline to Day 90. 2. Reduction in Liver-Related Symptoms: Evaluated using the Liver Disease Symptom Index 2.0 (LDSI 2.0), tracking changes in symptoms like abdominal discomfort and nausea from baseline to Day 90. 3. Improvement in General Well-Being: Measured through the General Well-Being Schedule (GWBS), comparing emotional and physical well-being scores from baseline to Day 90.Timepoint: Day 1, Day 30, Day 60, Day 90

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Countries

India

Contacts

Public ContactMs Arpita Malgi

Planet Ayurveda Private Limited

trade@planetayurveda.com8578888111

Outcome results