Comparative investigating the effect of valerian and Gabapentin on restless legs syndrome and sleep quality in dialysis patients referring to the dialysis ward of Ali Ibn Abi Taleb Hospital of Rafsanjan, 2021
Comparison the effect of Valerian and Gabapentin on sleep quality and restless legs syndrome in dialysis patients referring to the dialysis ward of Ali Ibn Abitaleb Hospital of Rafsanjan, 2021
Design
Randomized, cross over clinical trial with control group
Settings and conduct
In this clinical trial, the study population are dialysis patients who will referring to the dialysis ward of Ali Ibn Abitaleb Hospital of Rafsanjan. Participants will select by convenience sampling method based on inclusion criteria and will allocate using the toss of coin. Demographic questionnaire, Pittsburgh Sleep Quality and International Restless Legs Syndrome questionnaires will complete in both groups before and after the duration of intervention. Participants will be divided into two groups of A (will receive Valerian ) and B (will receive Gabapentin ). After the end of the intervention, one month will be consider as a wash out period and then, both groups will replace.
Participants/Inclusion and exclusion criteria
Getting a score above 10 from the Restless Legs questionnaire; score above 5 of the Sleep Quality Questionnaire; age over 14 years old; signing the inform consent for participate in the study; satisfaction for taking drugs; BMI less than 30 and Blood pressure higher than 110/70 are inclusion criteria. Allergy to Valerian; having a physical disability; having mental disorders and being treated with psychiatric drugs; deafness or blindness; pregnancy and taking Gabapentin routinely before hand are exclusion criteria.
Intervention groups
Group A: patients will take Valerian (capsule: 530 mg) and in group B patients will take Gabapentin (capsule: 100 mg), for one month. In the next step, after the end of the intervention, one month will be consider as a wash out period and then, two groups will replace.
Main outcome variables
Score of restless legs syndrome; score of sleep quality
General information
Reason for update
Acronym
IRCT registration information
IRCT registration number:IRCT20150713023190N9
Registration date:2021-10-19, 1400/07/27
Registration timing:prospective
Last update:2021-10-19, 1400/07/27
Update count:0
Registration date
2021-10-19, 1400/07/27
Registrant information
Name
Tabandeh Sadeghi
Name of organization / entity
Rafsanjan University of Medical Sciences
Country
Iran (Islamic Republic of)
Phone
+98 34 3425 5900
Email address
t.sadeghi@rums.ac.ir
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2021-10-23, 1400/08/01
Expected recruitment end date
2022-04-20, 1401/01/31
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Comparative investigating the effect of valerian and Gabapentin on restless legs syndrome and sleep quality in dialysis patients referring to the dialysis ward of Ali Ibn Abi Taleb Hospital of Rafsanjan, 2021
Public title
Comparison the effect of valerian and Gabapentin on restless legs syndrome and sleep quality in dialysis patients
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria:
Getting a score above 10 from the Restless Legs questionnaire
Getting a score above 5 of the Sleep Quality Questionnaire
Age over 14 years old
Inform consent for participate in the study
Satisfaction for taking drugs
BMI less than 30
Blood pressure> 110/70
Exclusion criteria:
Allergy to valerian
Having a physical disability
Having mental disorders and being treated with psychiatric drugs
Deafness or blindness
pregnancy
Taking Gabapentin routinely beforehand
Age
From 14 years old
Gender
Both
Phase
2-3
Groups that have been masked
No information
Sample size
Target sample size:
40
Randomization (investigator's opinion)
Randomized
Randomization description
This is a cross over study. Initially, the patients will allocate into two groups by the toss of a coin. After the end of the intervention, one month will be consider as a wash out period and then, two groups will replace.
Blinding (investigator's opinion)
Not blinded
Blinding description
Placebo
Not used
Assignment
Crossover
Other design features
Secondary Ids
empty
Ethics committees
1
Ethics committee
Name of ethics committee
Ethics Committee of Rafsanjan University of Medical Sciences
Street address
Imam Ali Blvd
City
Rafsanjan
Province
Kerman
Postal code
7717933777
Approval date
2021-10-02, 1400/07/10
Ethics committee reference number
IR.RUMS.REC.1400.136
Health conditions studied
1
Description of health condition studied
Restless leg syndrome
ICD-10 code
G25.81
ICD-10 code description
Restless legs syndrome
Primary outcomes
1
Description
Mean score of restless leg syndrome
Timepoint
Before and after the each of intervention
Method of measurement
International Restless Legs Syndrome Questionnaire
2
Description
Mean score of sleep quality
Timepoint
Before and after the each of intervention
Method of measurement
Pittsburgh Sleep Quality Questionnaire
Secondary outcomes
empty
Intervention groups
1
Description
Intervention group A: patients will take Sedamin ( capsule: 530 mg made by Isfahan Gol Daroo Company), as a single dose one hour before bedtime for one month.
Category
Treatment - Drugs
2
Description
Intervention group B: patients will take Gabapentin (capsule: 100 mg ), as a single dose one hour before bedtime for one month.
Category
Treatment - Drugs
Recruitment centers
1
Recruitment center
Name of recruitment center
Ali Ibn Abitaleb Hospital
Full name of responsible person
Ali Mousavi
Street address
Mofateh Blvd
City
Rafsanjan
Province
Kerman
Postal code
7717933777
Phone
+98 34 3428 0001
Fax
Email
aliebn@rums.ac.ir
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Rafsanjan University of Medical Sciences
Full name of responsible person
Ali Shamsizadeh
Street address
Imam Ali Blvd
City
Rafsanjan
Province
Kerman
Postal code
7717933777
Phone
+98 34 3428 0097
Fax
Email
vcrt@rums.ac.ir
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Rafsanjan 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
Rafsanjan University of Medical Sciences
Full name of responsible person
Iman Hajizadeh Khanaman
Position
Nurse
Latest degree
Bachelor
Other areas of specialty/work
Nursery
Street address
Parastar Ave
City
Rafsanjan
Province
Kerman
Postal code
7718796755
Phone
+98 34 3425 5900
Fax
+98 34 3425 8497
Email
iman_hajizadeh@yahoo.com
Person responsible for scientific inquiries
Contact
Name of organization / entity
Rafsanjan University of Medical Sciences
Full name of responsible person
Tabandeh Sadeghi
Position
Associate professor
Latest degree
Ph.D.
Other areas of specialty/work
Nursery
Street address
Parastar Ave
City
Rafsanjan
Province
Kerman
Postal code
7718796755
Phone
+98 34 3425 5900
Fax
+98 34 3425 8497
Email
t.b_sadeghi@yahoo.com
Person responsible for updating data
Contact
Name of organization / entity
Rafsanjan University of Medical Sciences
Full name of responsible person
Tabandeh Sadeghi
Position
Associate professor
Latest degree
Ph.D.
Other areas of specialty/work
Nursery
Street address
Parastar Ave
City
Rafsanjan
Province
Kerman
Postal code
7718796755
Phone
+98 34 3425 5900
Fax
+98 34 3425 8497
Email
t.b_sadeghi@yahoo.com
Sharing plan
Deidentified Individual Participant Data Set (IPD)
No - There is not a plan to make this available
Justification/reason for indecision/not sharing IPD
Confidentiality of data
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