The study of memantin effect on the treatment of post herpetic neuralgia (PNH)
Design
Randomized, blinded, clinical trail include 16 patients; phase 3
Settings and conduct
This study is conducted on patients with shingles and post herpetic neuralgia. The patients who refer to Endocrinology Clinic of Imam Reza Hospital were randomly divided into two groups of intervention and control groups (8 patient in each group). In the intervention group, memantine was coadministered with other drugs administered in the first week at a dose of 5 mg twice daily and then 10 mg twice daily up to 8 weeks. In the control group, other commonly prescribed drugs other than memantine are prescribed to the patient. After completing the pain questionnaire and warm-cold and presence of pain the researcher performed the efficacy of memantine in controlling pain will be assessed.
The participants (patients) and the researcher who have the task of sampling in the study are all blind during the study.
Participants/Inclusion and exclusion criteria
Patients with diagnosis of post herpetic neuralgia who have been suffering from painful rash for maximum 4 weeks and aged 18 to 75 years old.
Exclusion criteria: Patients with diabetes-induced neuropathy; Patients with cardiovascular disease; Patients with epilepsy; Patients with hepatic failure
Intervention groups
Intervention group: ٌWill be received routin treatment and memantine 5 mg twice daily in the first week and received memantine 10 mg from week 2 to week 8 twice daily
Control group: Routin treatmet
Main outcome variables
Pain; numbness; Heat and cold sensation
General information
Reason for update
Acronym
IRCT registration information
IRCT registration number:IRCT20180404039187N6
Registration date:2020-01-31, 1398/11/11
Registration timing:retrospective
Last update:2020-01-31, 1398/11/11
Update count:0
Registration date
2020-01-31, 1398/11/11
Registrant information
Name
Elnaz Shaseb
Name of organization / entity
Country
Iran (Islamic Republic of)
Phone
+98 41 1337 2250
Email address
shasebe@tbzmed.ac.ir
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2019-05-15, 1398/02/25
Expected recruitment end date
2019-11-22, 1398/09/01
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Study the effects of memantine on pain control and post herpetic neuralgia (PHN) in pateints with shingles; Double blind randomized clinical trial
Public title
Evaluation of the effect of memantine on post herpetic neuralgia (PHN)
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria:
Patients aged 18 to 75 years
Patients who have been suffering from painful rash for maximum 4 weeks in these patients and treated with herpes neuralgia medications
Exclusion criteria:
Patients with diabetes-induced neuropathy
Patients with cardiovascular disease
Patients with epilepsy
Patients with hepatic failure
Age
From 18 years old to 75 years old
Gender
Both
Phase
3
Groups that have been masked
No information
Sample size
Target sample size:
16
Randomization (investigator's opinion)
Randomized
Randomization description
Arrangement of the randomization process:
1) Determining the volume of each block (quadruple blocks)
2) Preparing the list of the blocks and assigning a number to each of them
AABB(1) ABAB(2) ABBA(3) BBAA(4) BABA(5) BAAB(6)
3) Choosing random numbers between 1 and 6
4) Defining the treatment assignment list
For example: AABB(1)_BBAA(4)_ABAB(2)_BABA(5)
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 Tabriz University of Medical Sciences
Street address
Research & Technology Dept, Central Building No. 2, Third Floor, Tabriz University of Medical Sciences, Golghast St, Tabriz
City
Tabriz
Province
East Azarbaijan
Postal code
5166614766
Approval date
2019-05-06, 1398/02/16
Ethics committee reference number
IR.TBZMED.REC.1398.135
Health conditions studied
1
Description of health condition studied
Post Herpetic Neuralgia
ICD-10 code
G61.9
ICD-10 code description
Polyneuropathy, unspecified
Primary outcomes
1
Description
Change in heat and cold sensation
Timepoint
At the beginning and 8 weeks later
Method of measurement
Using a thermal probe
2
Description
Pain and numbness on the location of rash
Timepoint
At the beginning and 8 weeks later
Method of measurement
DN4 questionnaire
Secondary outcomes
empty
Intervention groups
1
Description
Intervention group: Memantine 5 mg twice daily in the first week and then 10 mg twice daily upto 8 weeks along with Routin treatment (Tab Acetaminophen 500 mg up to 4 times a day and Nortriptyline 10 mg up to twice daily for 8 weeks)
Category
Treatment - Drugs
2
Description
Control group: Routin treatment (Tab Acetaminophen 500 mg up to 4 times a day and Nortriptyline 10 mg up to twice daily for 8 weeks)
Category
Treatment - Drugs
Recruitment centers
1
Recruitment center
Name of recruitment center
Sina hospital
Full name of responsible person
Elnaz Shaseb
Street address
Sina Hospital, Hafez Sq., Azadi Ave,.
City
Tabriz
Province
East Azarbaijan
Postal code
5163639888
Phone
+98 41 3541 2101
Email
info@Sina.tbzmed.ac.ir
Web page address
https://sinahosp.tbzmed.ac.ir
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Tabriz University of Medical Sciences
Full name of responsible person
Abolghasem Jouyban
Street address
No. 2, Central Building, Tabriz University of Medical Sciences, Golgasht Ave., Azadi Ave.
City
Tabriz
Province
East Azarbaijan
Postal code
5166614766
Phone
+98 41 3337 2250
Email
Jouyban@tbzmed.ac.ir
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Tabriz University of Medical Sciences
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
Tabriz University of Medical Sciences
Full name of responsible person
Elnaz Shaseb
Position
Assistant Professor
Latest degree
Ph.D.
Other areas of specialty/work
Medical Pharmacy
Street address
Faculty of Pharmacy, Tabriz university of Medical Science, Golgaste Ave., Azadi Ave.
City
Tabriz
Province
East Azarbaijan
Postal code
5166614766
Phone
+98 41 3334 4198
Email
Elnaz_shaseb_64@yahoo.com
Person responsible for scientific inquiries
Contact
Name of organization / entity
Tabriz University of Medical Sciences
Full name of responsible person
Elnaz Shaseb
Position
Assistant Professor
Latest degree
Ph.D.
Other areas of specialty/work
Medical Pharmacy
Street address
Faculty of Pharmacy, Tabriz university of Medical Science, Golgaste Ave., Azadi Ave.
City
Tabriz
Province
East Azarbaijan
Postal code
5166614766
Phone
+98 41 3334 4198
Email
Shasebe@tbzmed.ac.ir
Person responsible for updating data
Contact
Name of organization / entity
Tabriz University of Medical Sciences
Full name of responsible person
abolfazl asdaghi
Position
Student
Latest degree
Medical doctor
Other areas of specialty/work
Medical Pharmacy
Street address
Faculty of Pharmacy, Tabriz university of Medical Science, Golgast Ave., Azadi Ave.
City
Tabriz
Province
East Azarbaijan
Postal code
5166614766
Phone
+98 44 3623 9978
Email
abolfazl.asdaghi_1995@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
Undecided - It is not yet known if there will be 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