A Phase III, Multicenter, Randomized, Open Label, Active Controlled, Parallel Group Study To Compare The Safety And Efficacy Of Acyclovir 1200 mg -Sustained Release With Acyclovir 800 mg- Immediate Release In Immunocompetent Patients With Uncomplicated Herpes Zoster

Authors
Category Primary study
Registry of TrialsClinical Trials Registry - India
Year 2009
INTERVENTION: Intervention1: Acyclovir: 1200 Mg Sustained Release TDS for 7 days Control Intervention1: Acyclovir: 800 Mg‐ Immediate Release 5 times a day for 7 days CONDITION: Uncomplicated Herpes Zoster PRIMARY OUTCOME: Proportion of patients who reached healing of 100% lesions‐‐‐‐‐‐Timepoint: Day 8, 15, 22 and 29 after initiation the treatment SECONDARY OUTCOME: Proportion of patients showing 100% loss of pain‐‐‐‐‐‐Timepoint: Day 4, 8, 15, 22 and 29 after initiation of the treatment Proportion of patients showing no formation of new lesions‐‐‐‐‐‐Timepoint: Day 4, 8, 15, 22 and 29 after; initiation of the treatment Reduction in severity of the zoster associated acute; pain‐‐‐‐‐‐Timepoint: Day 4, 8, 15, 22 and 29 after initiation of; the treatment INCLUSION CRITERIA: 1. Written informed consent from the subject. 2. Age above 18 years inclusive. 3. Diagnosis of herpes zoster clinically verified by a physician. 4. Presenting within 72 hrs of onset of a localized herpes zoster rash.
Epistemonikos ID: bf68a817fd3af29354999bc0e2baf401fb6ec399
First added on: Aug 22, 2024