None listed
Conditions
Interventions
Intervention1: Acyclovir: 1200 Mg Sustained Release TDS for 7 days
Control Intervention1: Acyclovir: 800 Mg- Immediate Release 5 times a day for 7 days
Sponsors
FDC Limited,142-148, S.V.Road, Jogeshwari (W), Mumbai - 400102, Maharashtra, India
Eligibility
Inclusion criteria
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.
Exclusion criteria
Exclusion criteria: 1. Subjects with any condition which in the opinion of the investigator makes the subject unsuitable for inclusion. 2. Complication of herpes zoster: ocular and visceral involvement, motor neuropathies, encephalitis, cerebrovascular complications, Severe disseminated infection: (more than 20 lesions outside the primary affected dermatome). 3. Subjects receiving chronic steroid therapy, immunosuppressive therapy, chemotherapy for malignancy. 4. HIV positive individual. 5. Subjects with autoimmune disorder. 6. SGOT and SGPT >/= 2 times the upper limit of normal. 7. Serum creatinine >/= 2 times the upper limit of normal. 8. Subject is a female who is pregnant or willing to get pregnant, not ready to use contraceptive measures during the trial period or breast feeding. 9. Subject has a history of medical illness that may affect the study outcome. 10. Known hypersensitivity to Acyclovir. 11. Subject with any Gastrointestinal disorder. 12. Subject who is consuming/ has received antiviral drugs during last 60 days. 13. Subject who is consuming/ has received. immunomodulators during last 60 days. 14. Subject who is consuming/ has received drugs, which have interaction with Acyclovir, during last 14 days. 15. Chronic alcoholics. 16. Drug abusers. 17. Participation in any other clinical trial during last 30 days.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Proportion of patients who reached healing of 100% lesionsTimepoint: Day 8, 15, 22 and 29 after initiation the treatment | — |
Secondary
| Measure | Time frame |
|---|---|
| Proportion of patients showing 100% loss of painTimepoint: Day 4, 8, 15, 22 and 29 after initiation of the treatment;Proportion of patients showing no formation of new lesionsTimepoint: Day 4, 8, 15, 22 and 29 after initiation of the treatment;Reduction in severity of the zoster associated acute painTimepoint: Day 4, 8, 15, 22 and 29 after initiation of the treatment | — |
Countries
India
Contacts
Public ContactDr. Vivek Bhosale
Manager Medical
Outcome results
None listed