The aim of this study is to investigate the effect of selenium on parkinsonians' tremor treatment. In total, 26 patients with parkinson disease will be enrolled the clinical trial. The trial is based on 2 periods of two months drug prescription with 2weeks drug free between prescriptions. Placebo and 200 µg selenium will be prescribed in order in each separated 2 months. Primary outcome of this study is tremor index based on Tremor Research Group Rating Scale. Severity of disease and side effects of the drug will be measured at the end of each month drug prescription. At least 2 declines in scale will be considered as appropriate response.
General information
Acronym
IRCT registration information
IRCT registration number:IRCT201101155612N1
Registration date:2014-01-09, 1392/10/19
Registration timing:prospective
Last update:
Update count:0
Registration date
2014-01-09, 1392/10/19
Registrant information
Name
Ali Mellat Ardekani
Name of organization / entity
Yazd University of Medical Siences
Country
Iran (Islamic Republic of)
Phone
+98 35 1822 4001
Email address
ali_mellat@ssu.ac.ir
Recruitment status
Recruitment complete
Funding source
Yazd University of Medical Sciences
Expected recruitment start date
2014-01-21, 1392/11/01
Expected recruitment end date
2014-04-21, 1393/02/01
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Evaluation of the effect of oral selenium administration on tremor reduction of Parkinsonians
Public title
Evaluation of the effect of oral selenium administration on tremor reduction of Parkinsonians
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusions: Idiopathic Parkinson disease; Age between 40 and 60 years; 6 months after diagnosis the disease; stage 2.5 or less based on MODIFIED HOEHN AND YAHR STAGING 5 ; Apparent or troublesome tremor
Exclusions:Other disease induses tremor; out of age range between 40 to 60 years
Age
From 40 years old to 60 years old
Gender
Both
Phase
2-3
Groups that have been masked
No information
Sample size
Target sample size:
26
Randomization (investigator's opinion)
N/A
Randomization description
Blinding (investigator's opinion)
Double blinded
Blinding description
Placebo
Used
Assignment
Single
Other design features
Secondary Ids
empty
Ethics committees
1
Ethics committee
Name of ethics committee
Yazd University of Medical Sciences
Street address
Bahonar Sq. Yazd. Iran
City
Yazd
Postal code
Approval date
2013-12-18, 1392/09/27
Ethics committee reference number
17/1/186945/ب
Health conditions studied
1
Description of health condition studied
Tremor
ICD-10 code
ْG20
ICD-10 code description
Parkinson disease
Primary outcomes
1
Description
Tremor rate
Timepoint
At beginning, End of 2 months
Method of measurement
Based on exam,Observation and Physical exam, indices (0-16) will be measured every 2 months (before and after treatment)
Secondary outcomes
empty
Intervention groups
1
Description
First intervention: one capsule (placebo or 200 mg selenium) daily for 2 months will be prescribed to 26 patients and indices will be measured at first and the end.
Second intervention: after 2 week's washout period, one capsule (placebo or 200 mg selenium) daily for 2 months will be prescribed to 26 patients and indices will be measured at first and the end.
Category
Treatment - Drugs
Recruitment centers
1
Recruitment center
Name of recruitment center
Khatamolanbia Clinic
Full name of responsible person
Ali Mellat Ardekani
Street address
Taaleghani Bl. Yazd
City
Yazd
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Yazd University of Medical Sciences
Full name of responsible person
Ezoddini Fatemeh
Street address
Bahonar Sq, Yazd, Iran
City
Yazd
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?