Comparison of sleep quality of the elderly before and after receiving valerian
Design
Sixty elderly people who were eligible to enter the study entered the study after obtaining consent and valerian gave them to take two pills with food daily and sleep quality was measured again after one month by the Pittsburgh Questionnaire.
Settings and conduct
Yas Rehabilitation Center
All the elderly underwent free clinical examination by the researcher.Eligible individuals completed the Pittsburgh Questionnaire.One month after the intervention, the questionnaire was completed and the sleep quality score was compared before and after the intervention.
Participants/Inclusion and exclusion criteria
60 years old, sleep disorders, no drug allergies, no underlying disease, ability to answer questions
Intervention groups
effect of valerian
Main outcome variables
sleep quality
General information
Reason for update
Acronym
IRCT registration information
IRCT registration number:IRCT20210427051105N1
Registration date:2021-05-02, 1400/02/12
Registration timing:retrospective
Last update:2021-05-02, 1400/02/12
Update count:0
Registration date
2021-05-02, 1400/02/12
Registrant information
Name
Ali Davati
Name of organization / entity
Country
Iran (Islamic Republic of)
Phone
+98 21 7770 9060
Email address
davati@shahed.ac.ir
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2016-09-22, 1395/07/01
Expected recruitment end date
2016-12-21, 1395/10/01
Actual recruitment start date
2016-09-22, 1395/07/01
Actual recruitment end date
2017-01-20, 1395/11/01
Trial completion date
2017-02-19, 1395/12/01
Scientific title
Study of sleep quality in the elderly and the effect of valerian
Public title
Effect of valerian in sleep quality
Purpose
Supportive
Inclusion/Exclusion criteria
Inclusion criteria:
sleep disorder
Ability to answer questions
Exclusion criteria:
History of allergies
Drug dependence
disease
Age
From 60 years old
Gender
Both
Phase
N/A
Groups that have been masked
No information
Sample size
Target sample size:
60
Actual sample size reached:
60
Randomization (investigator's opinion)
N/A
Randomization description
Blinding (investigator's opinion)
Not blinded
Blinding description
Placebo
Not used
Assignment
Single
Other design features
Secondary Ids
empty
Ethics committees
1
Ethics committee
Name of ethics committee
دانشگاه شاهد
Street address
Persian Gulf highway
City
Tehran
Province
Tehran
Postal code
3319118651
Approval date
2016-04-19, 1395/01/31
Ethics committee reference number
IR-SHAHED.REC.1395.131
Health conditions studied
1
Description of health condition studied
sleep disorder
ICD-10 code
ICD-10 code description
Primary outcomes
1
Description
Sleep quality score on the Pittsburgh Questionnaire
Timepoint
One month after starting the study
Method of measurement
Pittsburgh Sleep Quality Questionnaire
Secondary outcomes
empty
Intervention groups
1
Description
Intervention group: Valerian is given in the amount of two tablets (160 mg each tablet) per day to be taken with food.
Category
N/A
Recruitment centers
1
Recruitment center
Name of recruitment center
مرکز جامع توانبخشی سالمندان یاس
Full name of responsible person
خانم دکتر مرضیه شیرازی خواه
Street address
Sattar Khan St.-Bargh Alston
City
Tehran
Province
Tehran
Postal code
1453693611
Phone
+98 21 4428 0429
Email
dr_shirazikhah2002@yahoo.com
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Shahed University
Full name of responsible person
Ali Davati
Street address
Persian Gulf Highway
City
Tehran
Province
Tehran
Postal code
3319118651
Phone
+98 21 5121 2600
Email
a_davati@yahoo.com
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Shahed University
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
Shahed University
Full name of responsible person
Ali Davati
Position
Associate professor
Latest degree
Specialist
Other areas of specialty/work
Public Health/Community Medicine
Street address
Persian Gulf Highway
City
Tehran
Province
Tehran
Postal code
3319118651
Phone
+98 21 5121 2600
Email
davati@shahed.ac.ir
Person responsible for scientific inquiries
Contact
Name of organization / entity
Shahed University
Full name of responsible person
Ali Davati
Position
Associate professor
Latest degree
Specialist
Other areas of specialty/work
Public Health/Community Medicine
Street address
Persian Gulf Highway
City
Tehran
Province
Tehran
Postal code
3319118651
Phone
+98 21 5121 2600
Email
davati@shahed.ac.ir
Person responsible for updating data
Contact
Name of organization / entity
Shahed University
Full name of responsible person
Ali Davati
Position
Associate professor
Latest degree
Specialist
Other areas of specialty/work
Public Health/Community Medicine
Street address
Persian Gulf Highway
City
Tehran
Province
Tehran
Postal code
3319118651
Phone
+98 21 5121 2600
Email
davati@shahed.ac.ir
Sharing plan
Deidentified Individual Participant Data Set (IPD)
Undecided - It is not yet known if there will be a plan to make this available
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
No - There is not a plan to make this available
Clinical Study Report
Undecided - It is not yet known if there will be a plan to make this available