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COMPARATIVE EFFECTIVENESS OF SIDDHA TREATMENT REGIMEN AND KADUKKAI TEA (HERBAL BEVERAGE) IN MAJAL KAAMALAI (CHRONIC HEPATITIS-B)

COMPARATIVE EFFECTIVENESS OF SIDDHA TREATMENT REGIMEN AND KADUKKAI TEA (HERBAL BEVERAGE) IN PERUMANJAL NOI (CHRONIC HEPATITIS-B)-A PILOT RANDOMIZED CLINICAL TRAIL - NIL

Status
Recruiting
Phases
Phase 2
Study type
Interventional
Source
CTRI
Registry ID
CTRI/2023/09/057785
Enrollment
20
Registered
2023-09-18
Start date
Unknown
Completion date
Unknown
Last updated
2024-07-22

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

Conditions

Health Condition 1: B181- Chronic viral hepatitis B withoutdelta-agent

Interventions

Intervention1: Kadukkai tea (herbal beverage): Kadukkai tea (herbal beverage) DOSE-60 ml ADJUVANT-jaggery FREQUENCY-once in a day at evening ROUTE OF ADMINISTRATION-ORAL The study period willbe cons

Sponsors

None listed

Eligibility

Inclusion criteria

Inclusion criteria: Adults aged above 18 years of age, with inactive chronic hepatitis B (HB) or immune tolerant phase, with or without liver enzyme changes and having all of the following 1.HBsAg +ve for >6 months 2.Patientswhoarepositive forHBVwith increasedviral loadabove300 IU/mL 3.Not currently on antiviral therapy for Chronic hepatitis B or discontinued antiviral treatment for the last 3 months

Exclusion criteria

Exclusion criteria: ? Pregnant, lactatingwomen and Children ? Evidence of any other chronic liver disease ? Patient with hepatocellular carcinoma ? Coinfection with HIV,HCV ? Active substance or alcohol abuse and concurrent use of corticosteroids/NSAIDS or immunosuppressive agents ? Positive fibroscan or ultrasound elastography showing evidence of fibrosis (F3 and above) ? Allergic to the drug ingredients

Design outcomes

Primary

MeasureTime frame
Primary out come: ?Primary Outcome is mainly assessed by reduction in HBV viral load (Quantitative PCR) Timepoint: one year

Secondary

MeasureTime frame
? To evaluate the safety of the study drugs by assessing adverse events & laboratory investigations (viz., hemogram, liver function tests (LFT), renal function tests (RFT), lipid profile).Timepoint: one year

Countries

India

Contacts

Public ContactAISHWARYA A

NATIONAL INSTITUTE OF SIDDHA

draishwaryabalan6@gmail.com8526460100

Outcome results

None listed

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