Comparison of efficacy and safety of famciclovir and valacyclovir in patients with Herpes zoster.
- Conditions
- Herpes zoster
- Registration Number
- CTRI/2015/05/005765
- Lead Sponsor
- Jawaharlal Institute of Postgraduate Medical Education Research
- Brief Summary
Written informed consent will be obtained from all the study participants. Patients who satisfy the eligibility criteria will be enrolled in the study and their pain will be assessed using 10 point (100 mm) visual analog scale (VAS). Following this they will be randomized in the ratio of 1:1 to receive either famciclovir 500mg 3 times daily or valacyclovir 1000mg 3 times daily for a period of 7 days. The drugs will be given in similar looking capsules to blind both participant and the investigator.
Participants will be given adherence sheet as well as pain rating sheet to be filled for 7 days and to be returned during 8th day follow up visit. They will be evaluated for pain using VAS and crusting of the cutaneous lesions on day 8 by the blinded observer. The intake of analgesics if any during the study period will be recorded. Following this they will be given a sheet to note down the day of complete healing of lesions.
The lesions are defined as fully crusted when all the papules and vesicles in the affected dermatome had resolved and crusts had appeared. If all cutaneous lesions do not crust by 8th day, the patients will be continued on the same drug for another 3 days and will be followed up on 11th day to look for complete crusting of lesions. The participants will be followed over telephone at the end of four weeks and 12 weeks to find out the time taken for healing of cutaneous lesions as well as complete disappearance of pain. Healing is defined as the first time in which a patient had no papules, vesicles / crusts and after which did not develop them at any later visit.
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Not Yet Recruiting
- Sex
- All
- Target Recruitment
- 70
Patients attending Dermatology OPD, JIPMER diagnosed with uncomplicated herpes zoster presenting within 72 hrs of onset of rash will be recruited for the study based on eligibility criteria.
- Patients with complications of Herpes zoster, including ocular involvement, severe disseminated infections, motor neuropathies, encephalitis or cerebrovascular complications.
- Pregnant women or lactating mothers Patients with concurrent malignancy receiving chemotherapy Patients with autoimmune diseases and or on immunosuppressants HIV sero-positive Renal impairment Hepatic impairment.
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method Reduction in pain using visual analogue scale score Day 0 and day 8
- Secondary Outcome Measures
Name Time Method time taken for the full crusting of the lesions Day 0 and day 8
Trial Locations
- Locations (1)
Clinical Pharmacology, JIPMER
🇮🇳Pondicherry, PONDICHERRY, India
Clinical Pharmacology, JIPMER🇮🇳Pondicherry, PONDICHERRY, IndiaDr S SandhiyaPrincipal investigator9443492922sandhiyaselvarajan@gmail.com