Evaluation of efficacy and safety of carbamazepine and pregabalin for patients with post-shingles pain
Design
Clinical trial with two intervention groups, with parallel groups, not blinded, phase 2 on 40 patients, randomized
Settings and conduct
The office of counseling and guidance professors (pain fellowship and neurologist) is the place of data collection.The tool used is a questionnaire.The severity of pain is recorded according to the VAS criteria at the beginning and end.
Participants/Inclusion and exclusion criteria
Inclusion criteria All patients over 18 years of age with a history of neuropathic pain after shingles for at least one month Exclusion criteria Allergy to test drugs, pregnancy, seizures, serious psychiatric illness, use of drugs affecting neuropathic pain and pain other than neuropathic shingles
Intervention groups
a group of 150 mg of preglobulin daily and a group of 400 mg of carbamazepine for 4 weeks.
Main outcome variables
pain intensity based on the VAS scale
drug side effects
General information
Reason for update
Acronym
IRCT registration information
IRCT registration number:IRCT20210725051977N1
Registration date:2021-11-12, 1400/08/21
Registration timing:registered_while_recruiting
Last update:2021-11-12, 1400/08/21
Update count:0
Registration date
2021-11-12, 1400/08/21
Registrant information
Name
Masoud Khoshbin
Name of organization / entity
Country
Iran (Islamic Republic of)
Phone
+98 35 3726 9893
Email address
masoudkhoshbin@iauyazd.ac.ir
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2021-10-11, 1400/07/19
Expected recruitment end date
2021-11-21, 1400/08/30
Actual recruitment start date
2021-10-11, 1400/07/19
Actual recruitment end date
2021-11-21, 1400/08/30
Trial completion date
2021-11-22, 1400/09/01
Scientific title
Evaluation of the efficacy and safety of pregabalin and carbamazepine in patients with postherpetic neuralgia
Public title
Evaluation of efficacy and safety of pregabalin and carbamazepine in reducing pain
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria:
Age older than 18
History of postherpetic neuralgia for at least 1 month
Exclusion criteria:
History of Allergy to carbamazepine or pregabaline
History of kidney or liver disease
Age
From 18 years old
Gender
Both
Phase
2
Groups that have been masked
No information
Sample size
Target sample size:
40
Actual sample size reached:
40
Randomization (investigator's opinion)
Randomized
Randomization description
The sample size of the study is 40 patients. The first patient who admitted to the office and meets the inclusion criteria will be No. 1 and the 40th patient will be No. 40. In advance, using the https://www.random.org, from the "List Randomizer" section of the website, the numbers 1 to 40 is randomly divided into two groups of 20 (the first twenty patients for the carbamazepine group and the second 20 patients for the pregabalin group). Example: Number 5 is in the pregabalin group in randomization of numbers 1 to 40, therefore, the fifth patient who meets the inclusion criteria will be in the pregabalin group.
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
Ethics Committee of Yazd Azad University Medical School
Street address
Safaieh, Alam Square, Ali Ibn Abitaleb Medical School
City
Yazd
Province
Yazd
Postal code
8915813135
Approval date
2021-10-11, 1400/07/19
Ethics committee reference number
IR.IAU.YAZD.REC.1400.034
Health conditions studied
1
Description of health condition studied
Evaluation of the efficacy and safety of pregabalin and carbamazepine in patients with postherpetic neuralgia
ICD-10 code
B02.2
ICD-10 code description
Zoster with other nervous system involvement
Primary outcomes
1
Description
severity of post-herpetic neuralgia in each group
Timepoint
2, 5 and 8 weeks after starting the treatment
Method of measurement
visual analogue scale
Secondary outcomes
1
Description
frequency of adverse drug complications in each group
Timepoint
2, 5 and 8 weeks after starting the drug, or as soon as warning complications occurred
Method of measurement
check list including possible adverse drug reactions following carbamazepine or pregabalin
Intervention groups
1
Description
Intervention group: Oral carbazampine treatment group with a daily dose of 400 mg, for 8 weeks
Category
Treatment - Drugs
2
Description
Intervention group: Oral Pregabalin treatment group with a daily dose of 400 mg, for 8 weeks
Category
Treatment - Drugs
Recruitment centers
1
Recruitment center
Name of recruitment center
Personal office of Dr Masoud Khoshbin - Pain fellow
Full name of responsible person
Dr Masoud Khoshbin
Street address
40th dead end, in front of Sepah, Shahid Sadoughi Boulevard, Yazd- Iran
City
yazd
Province
Yazd
Postal code
8917694784
Phone
+98 35 3138 0155
Email
masoudkhoshbin@iauyazd.ac.ir
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Islamic Azad University
Full name of responsible person
Dr Ahmad Shajari
Street address
Safaieh, Alam Square, Ali Ibn Abitaleb Medical School
City
Yazd
Province
Yazd
Postal code
8915813135
Phone
+98 35 3821 0540
Email
a_shajari@yahoo.com
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Islamic Azad University
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
Academic
Person responsible for general inquiries
Contact
Name of organization / entity
Islamic Azad University
Full name of responsible person
Dr Masoud Khoshbin
Position
Associate professor
Latest degree
Specialist
Other areas of specialty/work
Anesthesiology
Street address
Yazd - Shahid Sadoughi Boulevard, in front of Sepah, 40th dead end,
City
yazd
Province
Yazd
Postal code
8917694784
Phone
+98 35 3138 0155
Email
masoudkhoshbin@iauyazd.ac.ir
Person responsible for scientific inquiries
Contact
Name of organization / entity
Islamic Azad University
Full name of responsible person
Dr Masoud Khoshbin
Position
Associate professor
Latest degree
Specialist
Other areas of specialty/work
Anesthesiology
Street address
Yazd - Shahid Sadoughi Boulevard, in front of Sepah, 40th dead end
City
yazd
Province
Yazd
Postal code
8917694784
Phone
+98 35 3138 0155
Email
masoudkhoshbin@iauyazd.ac.ir
Person responsible for updating data
Contact
Name of organization / entity
Islamic Azad University
Full name of responsible person
Negar veysi
Position
medical student
Latest degree
Medical doctor
Other areas of specialty/work
medical student
Street address
Yazd, Safaieh, Mehravaran Aghigh Complex, Block 4
City
yazd
Province
Yazd
Postal code
8915848558
Phone
+98 916 622 2853
Email
Negarveysi@yahoo.com
Sharing plan
Deidentified Individual Participant Data Set (IPD)
Undecided - It is not yet known if there will be a plan to make this available
Study Protocol
Undecided - It is not yet known if there will be a plan to make this available
Statistical Analysis Plan
No - There is not a plan to make this available
Informed Consent Form
Undecided - It is not yet known if there will be a plan to make this available
Clinical Study Report
Undecided - It is not yet known if there will be a plan to make this available
Analytic Code
Undecided - It is not yet known if there will be a plan to make this available
Data Dictionary
Undecided - It is not yet known if there will be a plan to make this available