Protocol summary

Summary
The objective of the study is to assess the effect of valerian root extract on sleep disturbances in menopausal women referred to selected health centers affiliated to Iran University of Medical Sciences 1388. More than 250 volunteered menopausal women will be interviewed using Pittsburg Sleep Quality Index Questionnaire (PSQI). About 100 of those who scored 5 or more will be invited to participate in the study and fill in a written consent form. Major inclusion and exclusion criteria include: • Not having physical and psychological diseases which may cause sleep problems • Not to use tobacco, drugs and alcohol • Appearance of any physical illness and psychological disorder while in study • Significant change in sleep conditions such as travel, shift work, etc. • Taking any additional medication during the study • Not taking the drug under investigation for more than 7 days during the study. Subjects will be randomly divided into two 50 intervention and control groups. The intervention group will receive Sedamin, 530 mg capsule, twice daily for one month and the control group will receive placebo capsule, at the same dose as the intervention group. Pittsburg Sleep Quality Index questionnaire score will be measured and compared in the two groups before and one month after the intervention.

General information

Acronym
IRCT registration information
IRCT registration number: IRCT138903252172N4
Registration date: 2010-06-29, 1389/04/08
Registration timing: retrospective

Last update:
Update count: 0
Registration date
2010-06-29, 1389/04/08
Registrant information
Name
Simin Taavoni
Name of organization / entity
Iran University of Medical Sciences
Country
Iran (Islamic Republic of)
Phone
+98 21 8820 8161
Email address
staavoni@iums.ac.ir
Recruitment status
Recruitment complete
Funding source
Iran University of Medical Sciences
Expected recruitment start date
2010-04-21, 1389/02/01
Expected recruitment end date
2010-05-22, 1389/03/01
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Effect of valerian root extract on sleep disturbances in menopausal women referred to selected health centers affiliated to Iran University of Medical Sciences 1388
Public title
Effect of valerian root extract on sleep disturbances in menopausal women referred to selected health centers affiliated to Iran University of Medical Sciences 1388
Purpose
Supportive
Inclusion/Exclusion criteria
Inclusion and Exclusion criteria: • Not having physical and psychological diseases which may cause sleep problems • Not to use tobacco, drugs and alcohol • Appearance of any physical illness and psychological disorder while in study • Significant change in sleep conditions such as travel, shift work, etc. • Taking any additional medication during the study • Not taking the drug under investigation for more than 7 days during the study
Age
From 50 years old to 60 years old
Gender
Female
Phase
1-2
Groups that have been masked
None
Sample size
Target sample size: 100
Randomization (investigator's opinion)
Randomized
Randomization description
Blinding (investigator's opinion)
Double blinded
Blinding description
Placebo
Used
Assignment
Parallel
Other design features

Secondary Ids

empty

Ethics committees

1

Ethics committee
Name of ethics committee
Nursing and Midwifery Faculty, Iran University of Medical Sciences
Street address
Valiasr street, after mirdamad,rashid yasemi street
City
Tehran
Country
Iran (Islamic Republic of)
Postal code
19395/4798
Approval date
2010-03-12, 1388/12/21
Ethics committee reference number
1603057

Health conditions studied

1

Description of health condition studied
Sleep disorders
ICD-10 code
F51.0, F51
ICD-10 code description
Nonorganic sleep disorders

Primary outcomes

1

Description
Sleep dysfunction score
Timepoint
Before intervention and one month after intervention
Method of measurement
Pittsburg Sleep Quality Index questionnaire

Secondary outcomes

empty

Intervention groups

1

Description
Intervention group, Sedamin, 530 mg capsule, twice daily for one month
Category
Treatment - Drugs

2

Description
Control group, Starch, placebo capsule, twice daily for one month
Category
Placebo

Recruitment centers

1

Recruitment center
Name of recruitment center
Emam Khomeyni health center
Full name of responsible person
Shiva Eshtehardi, midwife
Street address
Saat Square, Old Karaj Road, Ghods City (Ghaleh Hassan Khan)
City
Ghods
Country
Iran (Islamic Republic of)

2

Recruitment center
Name of recruitment center
Emam Hoseyn health center
Full name of responsible person
Zahra Eskandarizade, MD, manager
Street address
Shahid Alami street, Azadi Square, Old Karaj Road, Ghods City (Ghaleh Hassan Khan)
City
Ghods
Country
Iran (Islamic Republic of)

Sponsors / Funding sources

1

Sponsor
Name of organization / entity
Vice chancellor for reasearch, Iran University of Medical Sciences
Full name of responsible person
Dr. Saeid Abass Motevalain, Dr. Mazyar Moradie Lakea
Street address
Vanak Highway, Next to Milad Hospital
City
Tehran
Country
Iran (Islamic Republic of)
Grant name
Grant code / Reference number
کد 854
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Vice chancellor for reasearch, Iran 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
Nursing and Midwifery Faculty, Iran University of Medical Sciences
Full name of responsible person
Simin Taavoni
Position
M.Sc in Medical Education, M.Sc in Midfwifery Education, Academic Faculty Member & Resaercher
Other areas of specialty/work
Street address
3rd Floor, No.12, Nadjmabady St. Kazeroon St. Mirdamad Ave
City
Tehran
Country
Iran (Islamic Republic of)
Postal code
1919915375
Phone
00982182471000; 00982182471111
Fax
Email
staavoni@iums.ac.ir; staavoni14@yahoo.com
Web page address

Person responsible for scientific inquiries

Contact
Name of organization / entity
Nursing and Midwifery Faculty, Iran University of Medical Sciences
Full name of responsible person
Simin Taavoni
Position
M.Sc in Medical Education, M.Sc in Midfwifery Education, Academic Faculty Member & Resaercher
Other areas of specialty/work
Street address
3rd Floor, No.12, Nadjmabady St. Kazeroon St. Mirdamad Ave.
City
Tehran
Country
Iran (Islamic Republic of)
Postal code
1919915375
Phone
00982182471000; 00982182471111
Fax
Email
staavoni14@yahoo.com; staavoni@iums.ac.ir
Web page address

Person responsible for updating data

Contact
Name of organization / entity
Nursing and Midwifery Faculty, Iran University of Medical Sciences
Full name of responsible person
Simin Taavoni
Position
M.Sc in Medical Education, M.Sc in Midfwifery Education, Faculty Member & Researcher
Other areas of specialty/work
Street address
3rd Floor, No.12, Nadjmabady St. Kazeroon St. Mirdamad Ave. zip code: 1919915375
City
Tehran
Country
Iran (Islamic Republic of)
Postal code
1919915375
Phone
00982182471111; 00982182471000
Fax
Email
staavoni14@yahoo.com; staavoni@iums.ac.ir
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

Trial results

Abstract of published paper
Abstract<br /> OBJECTIVE:<br /> Sleep disturbances reduce the quality of life. About 50% of postmenopausal women experience sleep disturbances such as insomnia. Complementary and alternative medical therapies may be useful for the management of sleep disturbances among postmenopausal women. The aim of the present study was to evaluate the effects of valerian extract taken nightly on the improvement of sleep quality in postmenopausal women experiencing insomnia.<br /> METHODS:<br /> A randomized, triple-blind, controlled trial design was used for this study. Participants consisted of 100 postmenopausal women aged 50 to 60 years who were experiencing insomnia. A demographic data form and the Pittsburgh Sleep Quality Index were used to collect data. The women were randomly divided into two groups. Each group received either 530 mg of concentrated valerian extract or a placebo twice a day for 4 weeks. Descriptive and inferential statistics were used to analyze the data.<br /> RESULTS:<br /> A statistically significant change was reported in the quality of sleep of the intervention group in comparison with the placebo group (P < 0.001). Also, 30% of the participants in the intervention group and 4% in the placebo group showed an improvement in the quality of sleep (P < 0.001).<br /> CONCLUSIONS:<br /> Valerian improves the quality of sleep in women with menopause who are experiencing insomnia. Findings from this study add support to the reported effectiveness of valerian in the clinical management of insomnia.<br />
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