A Clinical Study to Evaluate the Efficacy and Safety of HepaMerz OA Syrup as supportive and maintenance therapy in Patients of Acute Hepatitis of varied etilogy.

A prospective, randomized, open-label, active-controlled, parallel-group clinical study to evaluate the efficacy and safety of HepaMerz OA syrup containing L-Ornithine L-Aspartate 250 mg per 5ml as supportive and maintenance therapy along with standard of care versus standard of care alone in patients with acute hepatitis of varied etiology. - Nil

Status

Active, not recruiting

Phases

Phase 4

Study type

Interventional

Source

CTRI

Registry ID

CTRI/2026/06/111827

Enrollment

200

Registered

2026-06-03

Start date

Unknown

Completion date

Unknown

Last updated

2026-06-22

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

Conditions

Health Condition 1: B179- Acute viral hepatitis, unspecified

Interventions

Intervention1: HepaMerz OA Syrup: 10 ml of HepaMerz OA Syrup administered orally twice daily (morning and evening) for up to 28 days as an adjuvant to standard care of treatment Control Intervention1:

Eligibility

Inclusion criteria

Inclusion criteria: 1. Male and Female patient in age group of 18 to 65 years of age. 2. Serum alanine aminotransferase (ALT) and or aspartate aminotransferase (AST) Greater than or equal to 2 times upper limit of normal (ULN) at screening. 3. Positive viral hepatitis markers (e.g., HBsAg, anti HCV, anti HAV IgM, anti HEV IgM, or other relevant viral serology), or Clinical history or exposure consistent with non viral hepatitis (e.g., alcohol use, hepatotoxic drugs toxins, metabolic liver disease, autoimmune disease, systemic viral infection). 4. Able and willing to provide informed consent and comply with study procedures.

Exclusion criteria

Exclusion criteria: 1. Known hypersensitivity to LOLA or excipients. 2. Known or documented cases of Acute Liver Failure (ALF) or Cirrhosis (based on previous medical history and records) 3. Known or suspected hepatocellular carcinoma or other active malignancy. 4. Severe renal impairment (serum creatinine greater than 3.0 mg per dL or eGFR less than 30 mL per min per 1.73 meter squre). 5. Pregnant or lactating mothers. 6. Participation in other investigational trials within 30 days. 7. Should not be on any anti viral drugs at time screening or 1 month prior. 8. Any other condition that, in the opinion of the investigator, would compromise the safety of the participant or the quality of the study data.

Design outcomes

Primary

Measure	Time frame
Mean change from baseline in liver function parameters - alanine aminotransferase (ALT), aspartate aminotransferase (AST), alkaline phosphatase (ALP), gamma glutamyl transferase (GGT), and total and direct bilirubin at Day 7, Day 14, and Day 28.Timepoint: Baseline day 1, Day 7, Day 14, and Day 28.	—

Secondary

Measure	Time frame
1. Change from baseline in symptom severity, as measured by Visual Analogue Scale (VAS) scores for anorexia, nausea, vomiting, abdominal discomfort, and fatigue, at Day 7, Day 14, and Day 28. 2. Safety and tolerability of HepaMerz OA syrup, assessed by the incidence, type, severity, seriousness, and relationship of adverse events (AEs) to study drug, including: .changes in vital signs, .clinically significant abnormalities in laboratory parameters, and .incidence of study drug discontinuation due to AEs. Timepoint: Baseline day 1, Day 7, Day 14, and Day 28.	—

Measure

Time frame

1. Change from baseline in symptom severity, as measured by Visual Analogue Scale (VAS) scores for anorexia, nausea, vomiting, abdominal discomfort, and fatigue, at Day 7, Day 14, and Day 28. 2. Safety and tolerability of HepaMerz OA syrup, assessed by the incidence, type, severity, seriousness, and relationship of adverse events (AEs) to study drug, including: .changes in vital signs, .clinically significant abnormalities in laboratory parameters, and .incidence of study drug discontinuation due to AEs. Timepoint: Baseline day 1, Day 7, Day 14, and Day 28.

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Countries

India

Contacts

Public ContactPurushotam

Auriga Research Private Limited

manojkarwa@aurigaresearch.com9313367656

Outcome results

None listed

Source: CTRI (via WHO ICTRP) · Data processed: Jun 29, 2026