This study aims to determine the effectiveness of acyclovir versus placebo in patients presenting with
pityriasis rosea as acyclovir may have a potential role in the treatment of pityriasis rosea.
Design
Clinical trial which is parallel group, double blind, randomized, phase 3 trial.
Settings and conduct
Dermatology department PNS Shifa hospital Karachi
Participants/Inclusion and exclusion criteria
Inclusion criteria Patients presenting with pityriasis rosea with either gender between Age 12-70 years.
Exclusion criteria patients with positive VDRL test, females with pregnancy or lactation, patients who have taken any other specific treatment for PR in last 01 week, patients with history of CRF and DM, HIV positive and patients with any cause of immunosuppression.
Intervention groups
Intervention group 1. Patients were treated with oral acyclovir 800mg 5 times/day for a duration of 7 days.
Intervention group 2 Patients were treated with placebo pill (glucose) 5 times/day daily for a duration of 7 days.
Main outcome variables
Clinical Response
General information
Reason for update
Acronym
IRCT registration information
IRCT registration number:IRCT20210823052264N2
Registration date:2023-02-06, 1401/11/17
Registration timing:prospective
Last update:2023-02-06, 1401/11/17
Update count:0
Registration date
2023-02-06, 1401/11/17
Registrant information
Name
Najia Ahmed
Name of organization / entity
PNS shifa
Country
Pakistan
Phone
+92 81 2864092
Email address
najiaomer@yahoo.com
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2023-02-10, 1401/11/21
Expected recruitment end date
2023-08-10, 1402/05/19
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Efficacy of Acyclovir in Pityriasis rosea, a double blind randomized controlled trial in a tertiary care hospital in Pakistan.
Public title
Efficacy of Acyclovir in Pityriasis rosea
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria:
Patients presenting with pityriasis rosea within first week of eruption of papulosquamous rash.
Either gender between Age 12-70 years.
Exclusion criteria:
Positive venereal disease research laboratory (VDRL) test.
Females with pregnancy or lactation.
Patients who have taken any other specific treatment for PR in last 01 week.
Patients with any cause of immunosuppression like chronic renal failure, diabetes mellitus, HIV positive and malignancy etc.
Age
From 12 years old to 70 years old
Gender
Both
Phase
3
Groups that have been masked
Participant
Care provider
Investigator
Outcome assessor
Sample size
Target sample size:
60
Randomization (investigator's opinion)
Randomized
Randomization description
Lottery method in the form of sealed envelopes
Blinding (investigator's opinion)
Double blinded
Blinding description
The participant, principle investigator, outcome assessors and care givers will all be blinded except for one physician who will open the sealed envelope and give the patient drug or placebo, as per the group code inside the envelope, without informing the patient if he is being given the drug or placebo
Placebo
Used
Assignment
Parallel
Other design features
Secondary Ids
empty
Ethics committees
1
Ethics committee
Name of ethics committee
Ethical Review Committee, PNS shifa
Street address
PNS Shifa Hospital, DHA phase 2, Karachi
City
Karachi
Postal code
75500
Approval date
2023-02-01, 1401/11/12
Ethics committee reference number
ERC/2023/DERM/01
Health conditions studied
1
Description of health condition studied
Pityriasis rosea
ICD-10 code
L42
ICD-10 code description
Pityriasis rosea
Primary outcomes
1
Description
Clinical Response based on clearance of lesions.
Timepoint
Patients in both the groups were evaluated clinically on 7th and 14th day of treatment
Method of measurement
Clinical Response Evaluation
Secondary outcomes
empty
Intervention groups
1
Description
Intervention group: In group “A” patients were treated with oral acyclovir 800mg 5 times/day for a duration of 7 days
Category
Treatment - Drugs
2
Description
Intervention group: In group “B” patients were treated with placebo pill (glucose) 5 times/day daily for a duration of 7 days.
Category
Placebo
Recruitment centers
1
Recruitment center
Name of recruitment center
PNS Shifa Hospital
Full name of responsible person
Dr Najia Ahmed
Street address
Main Korangi Rd, near Kala Pul، Clifton, Karachi, Karachi City, Sindh
City
Karachi
Postal code
74900
Phone
+92 21 48506592
Fax
+92 21 48506592
Email
najiaomer@yahoo.com
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
PNS SHIFA
Full name of responsible person
Dr Najia Ahmed
Street address
Main Korangi Rd, near Kala Pul، Clifton, Karachi, Karachi City, Sindh
City
Karachi
Postal code
74900
Phone
+92 21 48506592
Fax
+92 21 48506592
Email
najiaomer@yahoo.com
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
PNS SHIFA
Proportion provided by this source
100
Public or private sector
Private
Domestic or foreign origin
Domestic
Category of foreign source of funding
empty
Country of origin
Type of organization providing the funding
Persons
Person responsible for general inquiries
Contact
Name of organization / entity
PNS shifa
Full name of responsible person
Najia Ahmed
Position
Consultant
Latest degree
Specialist
Other areas of specialty/work
Dermatology
Street address
Dr najia ahmed 5th floor OPD tower PNS shifa hospital
City
Karachi
Province
Sindh
Postal code
74900
Phone
+92 81 2864092
Fax
Email
najiaomer@yahoo.com
Person responsible for scientific inquiries
Contact
Name of organization / entity
PNS shifa
Full name of responsible person
Najia Ahmed
Position
Consultant
Latest degree
Specialist
Other areas of specialty/work
Dermatology
Street address
Dr najia ahmed 5th floor OPD tower PNS shifa hospital
City
Karachi
Province
Sindh
Postal code
74900
Phone
+92 81 2864092
Fax
Email
najiaomer@yahoo.com
Person responsible for updating data
Contact
Name of organization / entity
PNS shifa
Full name of responsible person
Najia Ahmed
Position
Consultant
Latest degree
Specialist
Other areas of specialty/work
Dermatology
Street address
Dr najia ahmed 5th floor OPD tower PNS shifa hospital
City
Karachi
Province
Sindh
Postal code
74900
Phone
+92 81 2864092
Fax
Email
najiaomer@yahoo.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
Primary outcome
When the data will become available and for how long
1 month after publication and for life time.
To whom data/document is available
People Working in academic institutions
Under which criteria data/document could be used
Many
From where data/document is obtainable
najiaomer@yahoo.com
What processes are involved for a request to access data/document