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CTRI Number  CTRI/2015/05/005765 [Registered on: 11/05/2015] Trial Registered Prospectively
Last Modified On: 09/05/2015
Post Graduate Thesis  No 
Type of Trial  Interventional 
Type of Study   Drug 
Study Design  Randomized, Parallel Group, Active Controlled Trial 
Public Title of Study   Comparison of efficacy and safety of famciclovir and valacyclovir in patients with Herpes zoster. 
Scientific Title of Study   Comparison of efficacy, cost effectiveness and safety of famciclovir and valacyclovir in Herpes zoster – a randomized controlled double blind parallel arm study. 
Trial Acronym  FaVer study 
Secondary IDs if Any  
Secondary ID  Identifier 
NIL  NIL 
 
Details of Principal Investigator or overall Trial Coordinator (multi-center study)  
Name  Dr S Sandhiya 
Designation  Assistant Professor 
Affiliation  JIPMER 
Address  Department of Clinical Pharmacology JIPMER Puducherry

Pondicherry
PONDICHERRY
605006.
India 
Phone  9443492922  
Fax    
Email  sandhiyaselvarajan@gmail.com  
 
Details of Contact Person
Scientific Query
 
Name  Dr S Sandhiya 
Designation  Assistant Professor 
Affiliation  JIPMER 
Address  Department of Clinical Pharmacology JIPMER Puducherry

Pondicherry
PONDICHERRY
605006.
India 
Phone  9443492922  
Fax    
Email  sandhiyaselvarajan@gmail.com  
 
Details of Contact Person
Public Query
 
Name  Dr S Sandhiya 
Designation  Assistant Professor 
Affiliation  JIPMER 
Address  Department of Clinical Pharmacology JIPMER Puducherry

Pondicherry
PONDICHERRY
605006.
India 
Phone  9443492922  
Fax    
Email  sandhiyaselvarajan@gmail.com  
 
Source of Monetary or Material Support  
JIPMER intramural fund  
 
Primary Sponsor  
Name  Jawaharlal Institute of Postgraduate Medical Education Research 
Address  Pondicherry 605006 
Type of Sponsor  Research institution and hospital 
 
Details of Secondary Sponsor  
Name  Address 
NIL  NIL 
 
Countries of Recruitment     India  
Sites of Study  
No of Sites = 1  
Name of Principal Investigator  Name of Site  Site Address  Phone/Fax/Email 
Dr S Sandhiya  Clinical Pharmacology, JIPMER  Clinical Research lab, Department of Clinical Pharmacology III floor, Institute block, JIPMER, Dhanvantrinagar, Pondicherry
Pondicherry
PONDICHERRY 
9443492922

sandhiyaselvarajan@gmail.com 
 
Details of Ethics Committee  
No of Ethics Committees= 1  
Name of Committee  Approval Status 
IEC (Human studies) JIPMER  Approved 
 
Regulatory Clearance Status from DCGI  
Status 
Not Applicable 
 
Health Condition / Problems Studied  
Health Type  Condition 
Patients  Herpes zoster,  
 
Intervention / Comparator Agent  
Type  Name  Details 
Intervention  Famciclovir  500 mg 3 times daily for 7 days orally 
Comparator Agent  valacyclovir  1000 mg 3 times daily for 7 days orally 
 
Inclusion Criteria  
Age From  18.00 Year(s)
Age To  70.00 Year(s)
Gender  Both 
Details  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. 
 
ExclusionCriteria 
Details  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
 
 
Method of Generating Random Sequence   Permuted block randomization, fixed 
Method of Concealment   Sequentially numbered, sealed, opaque envelopes 
Blinding/Masking   Participant and Investigator Blinded 
Primary Outcome  
Outcome  TimePoints 
Reduction in pain using visual analogue scale score  Day 0 and day 8 
 
Secondary Outcome  
Outcome  TimePoints 
time taken for the full crusting of the lesions   Day 0 and day 8 
 
Target Sample Size   Total Sample Size="70"
Sample Size from India="70" 
Final Enrollment numbers achieved (Total)= "Applicable only for Completed/Terminated trials"
Final Enrollment numbers achieved (India)="Applicable only for Completed/Terminated trials" 
Phase of Trial   N/A 
Date of First Enrollment (India)   18/05/2015 
Date of Study Completion (India) Applicable only for Completed/Terminated trials 
Date of First Enrollment (Global)  Date Missing 
Date of Study Completion (Global) Applicable only for Completed/Terminated trials 
Estimated Duration of Trial   Years="2"
Months="5"
Days="10" 
Recruitment Status of Trial (Global)   Not Applicable 
Recruitment Status of Trial (India)  Not Yet Recruiting 
Publication Details    
Individual Participant Data (IPD) Sharing Statement

Will individual participant data (IPD) be shared publicly (including data dictionaries)?  

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.

 
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