The study of efficacy of memantin on nouropathy in diabetic pations
Design
a randomized double-blind, clinical trial
Settings and conduct
This study is conducted on 100 patients with Diabetic neuropathy (DN). The patients were randomly divided into two groups of control and intervention . In the test group, memantine was coadministered with other drugs administered in the first week at a dose of 5 mg twice daily and from the second week to the eighth week A dose of 10 mg and twice daily is given twice a day. In the control group, other commonly prescribed drugs other than memantine are prescribed to the patient. After completing the questionnaire and three monophilaman, warm-cold, and diaphasal tests, in order to diagnose the presence of neuropathy, the researcher performed the efficacy of memantine in controlling pain Will take.
Endocrinology Clinic of Tabriz Imam Reza Hospital
Participants/Inclusion and exclusion criteria
Inclusion criteria: Patients with diabetic neuropathy (PDN) aged between 18 and 75 years who have been diagnosed with PDN due to physical examinations. And patients treated with gababirzin (gabapentin and pregabalin)
Exclusion criteria:
pregnancy- Lactation- Cardiovascular disease- The absence of other neuropathies, such as neuropathy caused by herpes and trigeminal neuralgia, and ...- Sensitization to memantine or other formulation components Uncontrolled hypertention- Epilepcy- Liver failure- Renal insufficiency with creatinine clearance less than 30 ml / min
________________________________________
Intervention groups
Intervention group: received memantine 5 mg twice daily in the first week and received memantine 10 mg from week 2 to week 8 twice daily
Main outcome variables
Fasting blood sugar level, Glycosylated hemoglobin (three months sugar)(A1C), Heat and cold test, diapazon test, monofilament test, Pain and numbness on the soles of the feet and hands
General information
Reason for update
Acronym
IRCT registration information
IRCT registration number:IRCT20180404039187N5
Registration date:2019-09-05, 1398/06/14
Registration timing:registered_while_recruiting
Last update:2019-09-05, 1398/06/14
Update count:0
Registration date
2019-09-05, 1398/06/14
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
The study of efficacy of memantin on nouropathy in diabetic patients-double blind randomized clinical trial
Public title
Evaluation of the effect of memantine on diabetic neuralgia(diabetic nouropathy)(DN)
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria:
Patients with diabetic neuropathy (PDN) aged between 18 and 75 years who have been diagnosed with PDN due to physical examinations. And patients treated with gababirzin (gabapentin and pregabalin)
Exclusion criteria:
Pregnancy- Lactation- Cardiovascular disease- The presence of other neuropathies, such as neuropathy caused by herpes and trigeminal neuralgia, and ...- Sensitization to memantine or other formulation components- Uncontrolled hypertention- Epilepcy- Liver failure- Renal insufficiency with creatinine clearance less than 30 ml / min
Age
From 18 years old to 75 years old
Gender
Both
Phase
2-3
Groups that have been masked
Participant
Care provider
Sample size
Target sample size:
100
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)
Double blinded
Blinding description
The participants (patients) and the researcher who have the task of sampling in the study are all blind during the study. At the patient's level, blindness will be done as the patients do not know in which group (control or intervention group) they are in. The researcher on the basis of lable A or B without knowing the nature of A, B and according to the randomized list will give the medicine to pateints or not.
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
2019-06-11, 1398/03/21
Ethics committee reference number
IR.TBZMED.REC.1398.232
Health conditions studied
1
Description of health condition studied
diabetic nouropathy
ICD-10 code
E11.42
ICD-10 code description
Type 2 diabetes mellitus with diabetic polyneuropathy
Primary outcomes
1
Description
Fasting blood sugar level
Timepoint
At the beginning and 3 months after intervention
Method of measurement
Enzymatic method with Pars Azmoon kit
2
Description
Glycosylated hemoglobin (three months sugar)(A1C)
Timepoint
At the beginning and 3 months after intervention
Method of measurement
Immunoturbidimetryَ autoanalyzers assay
3
Description
Heat and cold test
Timepoint
At the beginning and 3 months later
Method of measurement
Using a thermophile tool (Diagnostic Tool for Neuropathy)
4
Description
diapazon test
Timepoint
At the beginning and 3 months later
Method of measurement
Using Diapazone (Diagnostic Tool for Neuropathy)
5
Description
monofilament
Timepoint
At the beginning and 3 months later
Method of measurement
Using a monofilament device (a diagnostic tool for neuropathy)
6
Description
Pain and numbness on the soles of the feet and hands
Timepoint
At the beginning and 3 months later
Method of measurement
DN4 questionnaire
Secondary outcomes
empty
Intervention groups
1
Description
Intervention group: received memantine 5 mg twice daily in the first week and received memantine 10 mg from week 2 to week 8 twice daily
Category
Treatment - Drugs
2
Description
Control group: routin care which includes Cap Gabapentin 300 mg once daily at night.
Category
Diagnosis
Recruitment centers
1
Recruitment center
Name of recruitment center
Endocrinology Clinic of Imam Reza Teaching Hospital
Full name of responsible person
Elnaz Shaseb
Street address
Imam Reza Hospital, Golgasht Ave., Azadi Ave.
City
Tabriz
Province
East Azarbaijan
Postal code
59-3347054
Phone
+98 41 3334 7054
Email
info@imamreza.tbzmed.ac.ir
Web page address
https://imamreza.tbzmed.ac.ir/
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Tabriz University of Medical Sciences
Full name of responsible person
ابوالقاسم جویبان
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
Fax
+98 41 3335 9680
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 144933344198
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 144933344198
Email
Elnaz_shaseb_64@yahoo.com
Person responsible for updating data
Contact
Name of organization / entity
Tabriz University of Medical Sciences
Full name of responsible person
Elnaz al.sadat Jafarzadeh chehraghi
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
jafarzadeelnaz042932@gmail.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
Data Dictionary
Undecided - It is not yet known if there will be a plan to make this available