Effect of narrow band UVB in combination with oral Acyclovir versus oral Acyclovir alone in prevention of Post Herpetic Neuralgia in patients with Herpes Zoster
To compare efficacy of narrow band UVB in combination with oral acyclovir versus oral acyclovir alone in prevention of post herpetic neuralgia in patients with herpes zoster
Design
community based, parallel group, randomized controlled trial
Settings and conduct
Dermatology Department Pak Emirates Military Hospital Rawalpindi
Participants/Inclusion and exclusion criteria
Inclusion Criteria:
● Both genders
● Patients having herpes zoster as per operational definition, reporting within 07 days of eruption of vesicles
Exclusion Criteria:
● Patients reporting after 07 days of onset of rash
● Patients having history of photosensitivity
● Patients who are unable to stand due to any musculoskeletal abnormalities
● Patients who are claustrophobic
● Patients in which genitalia is involved (L1 dermatome), as genitalia is usually shielded during nbUVB irradiation
● Patients in which scalp is involved (C2 dermatome), as because of hair scalp will not be properly irradiated
Intervention groups
After taking approval from Ethical Review Committee of the hospital, 100 patients with informed consent, fulfilling the inclusion criteria from Department of Dermatology were included in the study. Randomization was conducted through sequentially numbered opaque envelopes generated from a random numbers table into two groups of 50 patients each. Each patient was assigned a number at enrollment which defined a study assignment (Oral Acyclovir alone vs Oral Acyclovir plus nbUVB). 50 sample size was for Oral Acyclovir Alone group, (Control Group / Non-UV Group) while 50 sample size was for Oral Acyclovir plus nbUVB group, (Study Group / UV Group) as well. Both groups were given analgesic Paracetamol for pain relief with addition of Gabapentin if required (depending upon severity of pain).
Main outcome variables
pain relief using VRS at the end of treatment sessions and after 03 months follow-up period
General information
Reason for update
Acronym
IRCT registration information
IRCT registration number:IRCT20221215056829N1
Registration date:2022-12-20, 1401/09/29
Registration timing:retrospective
Last update:2022-12-20, 1401/09/29
Update count:0
Registration date
2022-12-20, 1401/09/29
Registrant information
Name
Abrar Ahmad Khalid
Name of organization / entity
Pak Emirates Military Hospital Rawalpindi
Country
Pakistan
Phone
+92 333 8511241
Email address
abrar2437@gmail.com
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2020-11-11, 1399/08/21
Expected recruitment end date
2021-05-10, 1400/02/20
Actual recruitment start date
2020-11-11, 1399/08/21
Actual recruitment end date
2021-05-10, 1400/02/20
Trial completion date
2021-05-10, 1400/02/20
Scientific title
Effect of narrow band UVB in combination with oral Acyclovir versus oral Acyclovir alone in prevention of Post Herpetic Neuralgia in patients with Herpes Zoster
Public title
narrow band UVB for post herpetic neuralgia (PHN)
Purpose
Prevention
Inclusion/Exclusion criteria
Inclusion criteria:
Both genders
Patients having herpes zoster as per operational definition, reporting within 07 days of eruption of vesicles
Exclusion criteria:
Patients reporting after 07 days of onset of rash
Patients having history of photosensitivity
Patients who are unable to stand due to any musculoskeletal abnormalities
Patients who are claustrophobic
Patients in which genitalia is involved (L1 dermatome), as genitalia is usually shielded during nbUVB irradiation
Patients in which scalp is involved (C2 dermatome), as because of hair scalp will not be properly irradiated
Age
No age limit
Gender
Both
Phase
N/A
Groups that have been masked
No information
Sample size
Target sample size:
100
Actual sample size reached:
100
Randomization (investigator's opinion)
Randomized
Randomization description
Randomization was conducted through sequentially numbered opaque envelopes generated from a random numbers table into two groups of 50 patients each. Each patient was assigned a number at enrollment which defined a study assignment (Oral Acyclovir alone vs Oral Acyclovir plus nbUVB)
Blinding (investigator's opinion)
Not blinded
Blinding description
Placebo
Not used
Assignment
Parallel
Other design features
Secondary Ids
empty
Ethics committees
1
Ethics committee
Name of ethics committee
Ethical Review Committee and Research Department Pak Emirates Military Hospital
Street address
Abid Majeed Road
City
Rawalpindi
Postal code
46000
Approval date
2020-09-02, 1399/06/12
Ethics committee reference number
A/28/EC/205/2020
Health conditions studied
1
Description of health condition studied
Patients suffering from Herpes Zoster and presenting within 7 days of onset of rash
ICD-10 code
B02
ICD-10 code description
Zoster [herpes zoster]
Primary outcomes
1
Description
Post herpetic neuralgia
Timepoint
At completion of treatment and after 3 months
Method of measurement
Verbal Rating Score
Secondary outcomes
empty
Intervention groups
1
Description
Intervention group: 50 patients received oral Acyclovir 800mg five times daily for 07 days along with analgesic Paracetamol ± Gabapentin, plus nbUVB delivered only to the affected dermatome while the rest of body was covered with clothing. The starting dose of nbUVB was 0.21 J/cm2 and it was increased by increment of 10% on every session as long as no adverse effects including persistent erythema, burning or itching were reported by the patient. The sessions were repeated 03 times per week to a maximum of 15 sessions or less if the pain settles completely.
Category
Treatment - Devices
2
Description
Control group: 50 patients received oral Acyclovir 800mg five times daily for 07 days along with analgesic Paracetamol ± Gabapentin. nbUVB was not administered to this group.
Category
Treatment - Drugs
Recruitment centers
1
Recruitment center
Name of recruitment center
Dermatology Department Pak Emirates Military Hospital
Full name of responsible person
Abrar Ahmad Khalid
Street address
Abid Majeed Road
City
Rawalpindi
Postal code
46000
Phone
+92 333 8511241
Email
abrar2437@gmail.com
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Pak Emirates Military Hospital
Full name of responsible person
Abrar Ahmad Khalid
Street address
Abid Majeed Road
City
Rawalpindi
Postal code
46000
Phone
+92 333 8511241
Email
abrar2437@gmail.com
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Pak Emirates Military Hospital
Proportion provided by this source
100
Public or private sector
Public
Domestic or foreign origin
Domestic
Category of foreign source of funding
empty
Country of origin
Type of organization providing the funding
Academic
Person responsible for general inquiries
Contact
Name of organization / entity
Pak Emirates Military Hospital
Full name of responsible person
Abrar Ahmad Khalid
Position
Consultant
Latest degree
Specialist
Other areas of specialty/work
Dermatology
Street address
Abid Majeed Road
City
Rawalpindi
Province
Punjab
Postal code
46000
Phone
+92 333 8511241
Email
abrar2437@gmail.com
Person responsible for scientific inquiries
Contact
Name of organization / entity
Pak Emirates Military Hospital
Full name of responsible person
Abrar Ahmad Khalid
Position
Consultant
Latest degree
Specialist
Other areas of specialty/work
Dermatology
Street address
Abid Majeed Road
City
Rawalpindi
Province
Punjab
Postal code
46000
Phone
+92 333 8511241
Email
abrar2437@gmail.com
Person responsible for updating data
Contact
Name of organization / entity
Pak Emirates Military Hospital
Full name of responsible person
Abrar Ahmad Khalid
Position
Consultant
Latest degree
Specialist
Other areas of specialty/work
Dermatology
Street address
Abid Majeed Road
City
Rawalpindi
Province
Punjab
Postal code
46000
Phone
+92 333 8511241
Email
abrar2437@gmail.com
Sharing plan
Deidentified Individual Participant Data Set (IPD)
Yes - There is a plan to make this available
Study Protocol
Yes - There is a plan to make this available
Statistical Analysis Plan
Yes - There is a plan to make this available
Informed Consent Form
Yes - There is a plan to make this available
Clinical Study Report
Yes - There is a plan to make this available
Analytic Code
Yes - There is a plan to make this available
Data Dictionary
Yes - There is a plan to make this available
Title and more details about the data/document
Effect of narrow band UVB in prevention of post herpetic neuralgia
When the data will become available and for how long
starting 1 month after publication
To whom data/document is available
people working in academic institutions
Under which criteria data/document could be used
data will be allowed to use after taking permission from the author
From where data/document is obtainable
data will be obtainable from author Abrar Ahmad Khalid, abrar2437@gmail.com
What processes are involved for a request to access data/document