The effect of treatment with vitamin E compared with relaxation in the treatment of restless legs syndrome (RLS) in HD patients in Shahroud Imam Hussain Hospital
The purpose of the study: efficacy of treatment with vitamin E compared with relaxation in the treatment of restless legs syndrome (RLS) in HD patients in Shahroud Imam Hussain Hospital.
Design study: randomized, double blind, without placebo control, single-center, phase 3 trial.
The study population: hemodialysis patients admitted in hemodialysis ward
Inclusion criteria: people with chronic kidney disease on hemodialysis for more than 6 months; RLS diagnosis; no previous history or RLS or genetic RLS; not taking anticonvulsion medications, opioids or dopamine agonists.
Exclusion criteria: previous history or genetic; Patients with RLS treatment of other drugs (such as dopamine agonists, anticonvulsants and opioids); Patients with mild RLS that there is a possibility of non-cooperation.
Sample size: 90.
Behavioral intervention: for 3 months during the intervention group counseling sessions for relaxation and yoga therapy training by a psychologist and a psychiatrist monitored for 15-minute sessions once a week for each patient is done And at the end of the questionnaire is to evaluate the changes in symptoms.
Intervention time: before and 3 months after intervention
Primary outcomes: the remission.
General information
Acronym
IRCT registration information
IRCT registration number:IRCT2016082129463N1
Registration date:2016-09-14, 1395/06/24
Registration timing:registered_while_recruiting
Last update:
Update count:0
Registration date
2016-09-14, 1395/06/24
Registrant information
Name
Hamraz Sadeghi
Name of organization / entity
Shahroud University of Medical Sciences
Country
Iran (Islamic Republic of)
Phone
+98 23 3239 5054
Email address
h.sadeghi@shmu.ac.ir
Recruitment status
Recruitment complete
Funding source
Shahroud University of Medical Sciences
Expected recruitment start date
2016-08-31, 1395/06/10
Expected recruitment end date
2017-02-28, 1395/12/10
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
The effect of treatment with vitamin E compared with relaxation in the treatment of restless legs syndrome (RLS) in HD patients in Shahroud Imam Hussain Hospital
Public title
The effect of treatment with vitamin E compared with relaxation in the treatment of restless legs syndrome (RLS) in HD patients
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria: people with chronic kidney disease on hemodialysis for more than 6 months; RLS diagnosis; no previous history or RLS or genetic RLS; not taking anticonvulsion medications, opioids or dopamine agonists.
Exclusion criteria: previous history or genetic; Patients with RLS treatment of other drugs (such as dopamine agonists, anticonvulsants and opioids); Patients with mild RLS that there is a possibility of non-cooperation.
Age
From 18 years old
Gender
Both
Phase
3
Groups that have been masked
No information
Sample size
Target sample size:
90
Randomization (investigator's opinion)
Randomized
Randomization description
Blinding (investigator's opinion)
Double blinded
Blinding description
Placebo
Not used
Assignment
Parallel
Other design features
Secondary Ids
empty
Ethics committees
1
Ethics committee
Name of ethics committee
Shahroud University of Medical Sciences
Street address
School of Medicine, Central Building Shahroud University of Medical Sciences, Haft Tir Square, Shahrud
City
Shahroud
Postal code
Approval date
2015-01-21, 1393/11/01
Ethics committee reference number
930/30
Health conditions studied
1
Description of health condition studied
restless legs syndrome
ICD-10 code
G25.8
ICD-10 code description
Other specified extrapyramidal and movement disorders
Primary outcomes
1
Description
The remission
Timepoint
Before and 3 months after intervention
Method of measurement
International RLS severity survey questionnaire
Secondary outcomes
empty
Intervention groups
1
Description
Behavioral intervention: For 3 months during the intervention group counseling sessions for relaxation and yoga therapy training By a psychologist and a psychiatrist monitored for 15-minute sessions once a week for each patient is done And at the end of the questionnaire is to evaluate the changes in symptoms.
Category
Behavior
2
Description
The control group treated with vitamin E for 3 months at a dose of 400 mg daily fall And to one of their family members is recommended that regular intake of medication by the patient monitor.
Category
Treatment - Drugs
Recruitment centers
1
Recruitment center
Name of recruitment center
Imam Hoseyn Hospital
Full name of responsible person
Hamraz Sadeghi
Street address
Imam Hoseyn Hospital, The end of the 28-meter Ayatollah Tohidi, Imam street
City
Shahrud
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Shahroud University of Medical Sciences
Full name of responsible person
Hamraz Sadeghi
Street address
School of Medicine, Central Building Shahroud University of Medical Sciences, Haft Tir Square, Shahrud
City
Shahroud
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Shahroud 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
Shahroud University of Medical Sciences
Full name of responsible person
Hamraz Sadeghi
Position
General physician
Other areas of specialty/work
Street address
School of Medicine, Central Building Shahroud University of Medical Sciences, Haft Tir Square, Shahroud
City
Shahroud
Postal code
Phone
+98 23 3239 5054
Fax
Email
Hamrazsadeghi6996@gmail.com
Web page address
Person responsible for scientific inquiries
Contact
Name of organization / entity
Shahroud University of Medical Sciences
Full name of responsible person
Munira Amerian
Position
Nephrology specialist
Other areas of specialty/work
Street address
Imam Hoseyn Hospital, The end of the 28-meter Ayatollah Tohidi, Imam street
City
Shahroud
Postal code
Phone
+98 23 3234 2000
Fax
Email
Amerian1060@yahoo.com
Web page address
Person responsible for updating data
Contact
Name of organization / entity
Shahroud University of Medical Sciences
Full name of responsible person
Hamraz Sadeghi
Position
General physician
Other areas of specialty/work
Street address
School of Medicine, Central Building Shahroud University of Medical Sciences, Haft Tir Square, Shahr
City
Shahroud
Postal code
Phone
+98 23 3239 5054
Fax
Email
Hamrazsadeghi6996@gmail.com
Web page address
Sharing plan
Deidentified Individual Participant Data Set (IPD)