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Compare the effect of magnesium and vitamin B6 with pramipexole in improving the symptoms of restless leg syndrome patients referred to the clinic by University of Medical Sciences.

Protocol summary

Summary
The aim of this study was to investigate the role of magnesium and vitamin B6 in improving to the symptoms of restless leg syndrome in patients referred to clinics in Arak University of Medical Sciences. This study is a single-blind study. The subjects studied in this study. Based on the Petersburg Sleep Quality Scale and the IRLS Index, their disease is evaluated.We will examine the therapeutic effect of reducing the score of the two questionnaires after medication.Patients were randomly assigned to three groups of magnesium, vitamin B6, and control. In addition, on top of prescription drugs (primaxyxol), one tablet of 40 mg of vitamin B6 or 250 mg of magnesium oxide is also prescribed, but The control group, in addition to the medication, is given only placebo. After one and two months after the intervention, the results are evaluated.Significance of entry can be RLS history for 6 months, ages 15 to 50 years, and exit criteria may include a lack of willingness to continue the study, the occurrence of pregnancy during the study, and the side effects of the drug. The sample size of this study was 72 people Is taken.The time required to collect information for this study is nine months.If this study shows the therapeutic effect of magnesium and vitamin B6 in improving symptoms of restless leg syndrome, it could be used as an adjunct to treatment.

General information

Acronym
IRCT registration information
IRCT registration number: IRCT2017070134806N1
Registration date: 2017-07-27, 1396/05/05
Registration timing: registered_while_recruiting

Last update:
Update count: 0
Registration date
2017-07-27, 1396/05/05
Registrant information
Name
Ali Khanmohammadi
Name of organization / entity
Arak University of Medical Sciences
Country
Iran (Islamic Republic of)
Phone
+98 86 3405 2631
Email address
ali.khanmohammadi@arakmu.ac.ir
Recruitment status
Recruitment complete
Funding source
Arak University of Medical Sciences
Expected recruitment start date
2017-07-01, 1396/04/10
Expected recruitment end date
2018-03-30, 1397/01/10
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Compare the effect of magnesium and vitamin B6 with pramipexole in improving the symptoms of restless leg syndrome patients referred to the clinic by University of Medical Sciences.
Public title
Comparison of the effect of magnesium and vitamin B6 on the improvement of restless leg syndrome
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria: Having a history of RLS for 6 months; Age 15 to 50 years; Lack of risk factors including pregnancy; Uremia; Diabetes and anemia; Lack of pregnancy; lack of renal impairment.Exclusion criteria: Unwillingness to continue the study; The occurrence of pregnancy during the study;The side effects of the drug.
Age
From 15 years old to 50 years old
Gender
Both
Phase
2-3
Groups that have been masked
No information
Sample size
Target sample size: 72
Randomization (investigator's opinion)
Randomized
Randomization description
Blinding (investigator's opinion)
Single blinded
Blinding description
Placebo
Used
Assignment
Parallel
Other design features

Secondary Ids

empty

Ethics committees

1

Ethics committee
Name of ethics committee
Arak University of Medical Sciences
Street address
Arak University of Medical Sciences, Basij Square, Taleghani Street.
City
Arak
Postal code
Approval date
2017-06-28, 1396/04/07
Ethics committee reference number
IR.ARAKMU.REC.1396.63

Health conditions studied

1

Description of health condition studied
Restless legs syndrome
ICD-10 code
G25.8
ICD-10 code description
Restless legs syndrome

Primary outcomes

1

Description
Improvement of sign restless leg syndrome
Timepoint
Befor, One & Two mounth after Intervention
Method of measurement
questionnaire of IRLS

Secondary outcomes

1

Description
Improve the quality of sleep
Timepoint
Befor, One & Two mounth after Intervention
Method of measurement
questionnaire of PSQ

Intervention groups

1

Description
For the first intervention group; Pramipexolel tablets, 75 mg oral, once a day for two months & Vitamin B6 tablets 40 mg oral, once a day for two month
Category
Treatment - Drugs

2

Description
For the second intervention group; Pramipexole 75 mg oral tablet, once a day for two months & Magnesium oxide 250 mg oral tablet, once a day for two months
Category
Treatment - Drugs

3

Description
For control group; Pramipexole 75 mg oral tablet, once a day for two months & Placebo oral tablet, once a day for two month
Category
Treatment - Drugs

Recruitment centers

1

Recruitment center
Name of recruitment center
Amir Al-Momenin Hospital
Full name of responsible person
Street address
City
Arak

Sponsors / Funding sources

1

Sponsor
Name of organization / entity
Arak University of Medical Sciences
Full name of responsible person
Ali Reza Rezai Ashtiani
Street address
Arak University of Medical Sciences, Basij Square, Taleghani Street
City
Arak
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Arak 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
Arak University of Medical Sciences
Full name of responsible person
Ali Jadidi
Position
Master of nursing
Other areas of specialty/work
Street address
Arak University of Medical Sciences, Basij Square, Taleghani Street
City
Arak
Postal code
Phone
+98 86 3417 3508
Fax
Email
jadidi.ali83@yahoo.comJadidi@arakmu.ac.ir
Web page address

Person responsible for scientific inquiries

Contact
Name of organization / entity
Arak University of Medical Sciences
Full name of responsible person
Ali Khan Mohammadi Hazaveh
Position
Bachelor of Nursing
Other areas of specialty/work
Street address
Arak University of Medical Sciences, Basij Square, Taleghani Street.
City
Arak
Postal code
Phone
+98 86 3417 3508
Fax
Email
Ali.khanmohammadi@arakmu.ac.iralikhan.nurse@gmail.com
Web page address

Person responsible for updating data

Contact
Name of organization / entity
Arak University of Medical Sciences
Full name of responsible person
Seyyed Mohammad Aghaei Pour
Position
Other areas of specialty/work
Street address
City
Postal code
Phone
00
Fax
Email
mohamadaqaee.nurse@gmail.com
Web page address

Sharing plan

Deidentified Individual Participant Data Set (IPD)
empty
Study Protocol
empty
Statistical Analysis Plan
empty
Informed Consent Form
empty
Clinical Study Report
empty
Analytic Code
empty
Data Dictionary
empty
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