1-Objectives:
The aim of our study was to find the efficacy of gabapentin in a low dose of 100mg only three times a week among hemodialysis(HD) patients with restless leg syndrome(RLS) .
2-design:
All Patients of hemodyalysis emam Khomeini hospital center.double blind, placebo control.single center. crossover clinical trial.109 patients.simple randomization.Trial phase not applicable.
3-setting and conduct:
patients fulfilled the criteria of RLS were randomized to either gabapentin (100 mg) or placebo after HD session for 4 weeks. After 2 weeks of washout period, the patients were switched from gabapentin to placebo or placebo to gabapentin for another 4 weeks. Severity of RLS symptoms before and after management with medication or placebo was evaluated with standardized questionnaire.
4-Participants including major eligibility criteria:
All Patients of hemodyalysis emam Khomeini hospital center with sevirity score more than 8.
5-Intervention:
drugs and plasebo
6- main outcome measures:
severity of RLS ;drug adverse effect
General information
Acronym
IRCT registration information
IRCT registration number:IRCT2014092319273N1
Registration date:2015-08-12, 1394/05/21
Registration timing:retrospective
Last update:
Update count:0
Registration date
2015-08-12, 1394/05/21
Registrant information
Name
Gholamreza Alizadeh attar
Name of organization / entity
Jundishapur University of Medical Sciences
Country
Iran (Islamic Republic of)
Phone
+98 61 3551 0025
Email address
alizadehattar.g@ajums.ac.ir
Recruitment status
Recruitment complete
Funding source
Investigator
Expected recruitment start date
2014-10-23, 1393/08/01
Expected recruitment end date
2015-01-21, 1393/11/01
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Comparative study of therapeutic effects of Gabapentin versus plasebo on Restless legs syndrome in hemodialysis patientes
Public title
Comparative study of therapeutic effects of Gabapentin versus plasebo on Restless legs syndrome in hemodialysis patientes
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion critria:
at least 3 months of hemodialysis ;international severity scale more than 8
Exclusion criteria:
Pregnancy ;Under treatment with psychotropic agents ;presence of another neurologic disease ;Iron deficiency anemia.
Age
No age limit
Gender
Both
Phase
N/A
Groups that have been masked
No information
Sample size
Target sample size:
109
Randomization (investigator's opinion)
Randomized
Randomization description
Blinding (investigator's opinion)
Double blinded
Blinding description
Placebo
Used
Assignment
Crossover
Other design features
Simple randomization first patient group 1 and seconde patient group 2 then third patient group 1 and so....
Secondary Ids
empty
Ethics committees
1
Ethics committee
Name of ethics committee
ethics committee of Ahvaz,Jundishapur University of Medical Sciences
Street address
I.R.Iran - Awz - Zip Code : 61357-15794
City
Ahwaz
Postal code
61357-15794
Approval date
2014-10-11, 1393/07/19
Ethics committee reference number
ajums.Rec.1393.230
Health conditions studied
1
Description of health condition studied
RLS: Restless Legs syndrome
ICD-10 code
G 25.8
ICD-10 code description
Other specified extrapyramidal and movement disorders
Primary outcomes
1
Description
Severity of restless leg syndrome
Timepoint
At first and 4 weeks after first drug administration and4 weeks after second drug administration
Method of measurement
with international scale
Secondary outcomes
1
Description
drug advers reaction
Timepoint
At first and 4 weeks after first drug administration and 4 weeks after second drug administration
Method of measurement
with question from patients
Intervention groups
1
Description
capsules of gabapentin 100mg after every hemodialysis for 4 weeks
axir pharmaceutical co.
Category
Treatment - Drugs
2
Description
capsule plasebo after every hemodialysis for 4 weeks.
the cartridge similar to real capsule was filled with starch powder
Category
Placebo
Recruitment centers
1
Recruitment center
Name of recruitment center
Hemodialysis center of emam khomeini hospital
Full name of responsible person
Sied sifollah beladi musavi
Street address
Golestan
City
Ahwaz
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Vice-chancellor of Research and Technology of Ahvaz,Jundishapur University of Medical Sciences
Full name of responsible person
sied sifollah beladi musavi
Street address
Hemodialysis center of emam khomeini hospital
City
Ahwaz
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Vice-chancellor of Research and Technology of Ahvaz,Jundishapur University of Medical Sciences
Proportion provided by this source
100
Public or private sector
empty
Domestic or foreign origin
empty
Category of foreign source of funding
empty
Country of origin
Type of organization providing the funding
empty
Person responsible for general inquiries
Contact
Name of organization / entity
Ahvaz,Jundishapur University of Medical Sciences
Full name of responsible person
Gholamreza alizadeh attar
Position
Internal residence
Other areas of specialty/work
Street address
cross abadan
City
Ahwaz
Postal code
61836-87739
Phone
+98 613552837
Fax
-
Email
sanysasan2002@yahoo.com
Web page address
Person responsible for scientific inquiries
Contact
Name of organization / entity
Ahvaz,Jundishapur University of Medical Sciences
Full name of responsible person
sied sifollah beladi musavi
Position
Nephrologist
Other areas of specialty/work
Street address
Golestan
City
Ahwaz
Postal code
ایران - اهواز - کد پ
Phone
+61 35510025
Fax
Email
beladimusavi@yahoo.com
Web page address
Person responsible for updating data
Contact
Name of organization / entity
Jundishapur University of Medical Sciences
Full name of responsible person
Gholamreza alizadeh attar
Position
Internist
Other areas of specialty/work
Street address
Golestan
City
Ahwaz
Postal code
6183687739
Phone
+98 35510025
Fax
N/A
Email
sanysasan2002@yahoo.com
Web page address
N/A
Sharing plan
Deidentified Individual Participant Data Set (IPD)