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A study to evaluate the effect of Arq-e-Mako and Arq-e-Kasni in children with hepatitis A.

Therapeutic evaluation of Arq-e-Mako and Arq-e-Kasni in pediatric hepatitis A:An open label interventional study - NIL

Status
Active, not recruiting
Phases
Phase 2
Study type
Interventional
Source
CTRI
Registry ID
CTRI/2025/11/097869
Enrollment
36
Registered
2025-11-21
Start date
Unknown
Completion date
Unknown
Last updated
2025-12-08

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

Conditions

Health Condition 1: B159- Hepatitis A without hepatic coma

Interventions

Intervention1: Arq-e-Mako, Arq-e-Kasni: Dose will be administered orally, twice a day before meal for 21 days. The dose will be calculated as a proportion of the adult dose of 120 ml. Age group 2 to

Sponsors

State Unani Medical College and Hospital
Lead Sponsor

Eligibility

Inclusion criteria

Inclusion criteria: Patients of either gender. Patients aged 2 to 18 years. Clinically diagnosed or presumptive cases of hepatitis A. IgM anti-HAV positive cases. Elevated ALT or AST above the upper limit of normal. Guardians or parents willing to provide informed consent and follow the study protocol.

Exclusion criteria

Exclusion criteria: Patients of hepatitis A with complications such as hepatic cellular failure where PT-INR is more than 2 without hepatic encephalopathy, or more than 1.5 with hepatic encephalopathy. Hepatitis A associated with systemic or chronic diseases such as tuberculosis, cardiac disease, renal disease, or other hepatic diseases. Known cases of hepatitis B, hepatitis C, hepatitis E, or drug-induced hepatitis. Patients receiving any other therapy within the last 3 days. Patients who are unsure about attending study visits regularly.

Design outcomes

Primary

MeasureTime frame
Change in biochemical parameters, namely ALT, AST, ALP, and total serum bilirubin. Timepoint: Biochemical parameters will be assessed at baseline, 14th day, and 21st day.

Secondary

MeasureTime frame
Proportion of patients achieving clinical recovery as evidenced by clinical parameters such as fever, weakness, nausea and vomiting, icterus, and tender or enlarged liver. Timepoint: Clinical parameters will be assessed at baseline, 7th day, 14th day, and 21st day.

Countries

India

Contacts

Public ContactZuber Ahmad

State Unani Medical College and Hospital

zuber512ahmad@gmail.com7379219252

Outcome results

None listed

Source: CTRI (via WHO ICTRP) · Data processed: Feb 4, 2026