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Study to see the effect of Ayurvedic medicines Bhumyamalaki Vati and Shyonaka Hima along with standard treatment in patients with chronic hepatitis B

Clinical evaluation of Bhumyamalaki vati and Shyonaka hima as an adjunct with the standard therapy in chronic Hepatitis B - NIL

Status
Recruiting
Phases
Phase 2
Study type
Interventional
Source
CTRI
Registry ID
CTRI/2025/11/097675
Enrollment
30
Registered
2025-11-18
Start date
Unknown
Completion date
Unknown
Last updated
2026-03-02

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

Conditions

Health Condition 1: K739- Chronic hepatitis, unspecified

Interventions

None listed

Sponsors

AKSHITA
Lead Sponsor

Eligibility

Inclusion criteria

Inclusion criteria: 1. Patients between the age group of 18 to 65 years. 2. Patients irrespective of sex, religion and occupation. 3. Patients with ALT levels ranging from the upper limit of normal to twice the upper limit of normal 41 to 82 will be selected. 4. Patients with low level of HBV DNA will be selected less then 20,000IU/ml for HBeAg positive patients and less then 2000IU/ml for HBeAg negative patients. 5. Patients with symptoms and signs of chronic hepatitis B and diagnosed chronic hepatitis B infection will be selected.

Exclusion criteria

Exclusion criteria: 1. Concurrent infection with hepatitis C, D or other hepatic viral infection , autoimmune hepatitis or alcoholic hepatitis. 2. Significant comorbidities such as liver cirrhosis, renal failure or cardiovascular diseases. 3. Pregnant or breastfeeding women. 4. Decompensated liver disease. 5. Patient suffering from Ascites, hepatic encephalopathy, variceal bleeding. 6. Hepatocellular carcinoma. 7. Patients who have previously taken Interferons or antiviral agents, Corticosteroids,immunosuppressive drug.

Design outcomes

Primary

MeasureTime frame
Reduction in HBV DNA levels with ALT normalization after treatment.Timepoint: Evaluation of reduction in viral load (HBV DNA) and ALT levels will be assessed at follow-up visits scheduled on the 30th, 60th, and 90th day after initiation of treatment.

Secondary

MeasureTime frame
Evaluation of improvement in clinical symptoms, liver enzyme normalization trend, and overall quality of life; along with assessment of safety and tolerability of the intervention.Timepoint: 18 months

Countries

India

Contacts

Public ContactAKSHITA

Quadra Institute Of Ayurveda And Hospital

Ayu.abhishek@gmail.com9458636020

Outcome results

None listed

Source: CTRI (via WHO ICTRP) · Data processed: Mar 14, 2026