Protocol summary

Summary
The purpose of this study is to compare the effect of valerian on sleep quality، insomnia severity، anxiety and Hot flashes in postmenopausal women. This study is a randomized clinical trial among 142 postmenopausal women referred to clinics of Tehran University of Medical Sciences, which have sleep disorder and Hot flashes. The women were randomly divided into two groups. Each group received either 700 mg of valerian extract or a placebo (two 350 mg capsules an hour before bedtime) for 4 weeks. After wash out period ( two weeks ) the intervention and control groups are moved together again. After one month will be reviewed sleep quality، insomnia severity، anxiety and hot flashes in two groups. Anxiety levels sleep quality، insomnia severity and hot flashes were measured before and after intervention. Symptoms between two groups are compared with each other.

General information

Acronym
IRCT registration information
IRCT registration number: IRCT201102275912N3
Registration date: 2012-07-07, 1391/04/17
Registration timing: registered_while_recruiting

Last update:
Update count: 0
Registration date
2012-07-07, 1391/04/17
Registrant information
Name
Mandana Mir Mohammad Ali Ei
Name of organization / entity
Tehran University of Medical Scinces
Country
Iran (Islamic Republic of)
Phone
+98 21 6692 7171
Email address
mirmohammad@tums.ac.ir
Recruitment status
Recruitment complete
Funding source
Tehran University of Medical Sciences (TUMS)
Expected recruitment start date
2012-02-20, 1390/12/01
Expected recruitment end date
2012-09-19, 1391/06/29
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Evaluation the effect of valerian on sleep quality، insomnia severity، anxiety and hotflash in menopause women
Public title
Evaluation the effect of Valerian on sleep quality, insomnia severity, anxiety and hot flash in menopause women
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria: Their age is between 60-45 years ; They have passed at least one year of amenorrhea ; Have a sleep disorder. More Pystbrg index equal to 5 ; not using Of drugs, tranquilizers, sleeping hormone replacement ; Do not have chronic systemic disease known to affect sleep ; Do not have mental illness ; have not consume Tobacco (cigarettes and shisha) and alcohol ; During a recent divorce, serious illness or death of family members is not really happening ; According to the research units having hot flashes Exclusion criteria: If the samples during the study of drugs, tranquilizers, sleeping or using hormone replacement ; If during the study divorce, serious illness or death of family members happened to be ; The use of tobacco (cigarettes or shisha) volatile during the research ; Iregular use of Valerian
Age
From 45 years old to 65 years old
Gender
Female
Phase
2-3
Groups that have been masked
None
Sample size
Target sample size: 142
Randomization (investigator's opinion)
Randomized
Randomization description
Blinding (investigator's opinion)
Double blinded
Blinding description
Placebo
Used
Assignment
Crossover
Other design features

Secondary Ids

empty

Ethics committees

1

Ethics committee
Name of ethics committee
Tehran University of Medical Sciences
Street address
6th Floor., University of Central Organization, Ghods St,Keshavarz Blvd
City
Tehran
Country
Iran (Islamic Republic of)
Postal code
Approval date
2010-09-23, 1389/07/01
Ethics committee reference number
1298/130/د

Health conditions studied

1

Description of health condition studied
Menopausal and other perimenopausal disorders
ICD-10 code
N95
ICD-10 code description
Menopausal and other perimenopausal disorders

Primary outcomes

1

Description
sleep quality
Timepoint
Before intervention, one month after the intervention, One month after the second intervention
Method of measurement
Questionnaire

2

Description
hotflash
Timepoint
Before intervention, one month after the intervention, One month after the second intervention
Method of measurement
VAS

3

Description
insomnia severity
Timepoint
Before intervention, one month after the intervention, One month after the second intervention
Method of measurement
Questionnaire

4

Description
anxiety
Timepoint
Before intervention, one month after the intervention, One month after the second intervention
Method of measurement
Questionnaire

Secondary outcomes

1

Description
side effect of drug
Timepoint
Beginning of the study , after 1 month , end of the study
Method of measurement
by questionnaire Pittsburgh Sleep Quality Index

Intervention groups

1

Description
Valerian 700 mg daily (two capsules 350 mg) one hour before bedtime for a period of 1 month
Category
Treatment - Drugs

2

Description
placebo 700 mg daily (two capsules 350 mg starch) one hour before bedtime for a period of 1 month
Category
Placebo

Recruitment centers

1

Recruitment center
Name of recruitment center
Farmanfarmaeyan clinic
Full name of responsible person
Tahere Zendedel
Street address
In front of Bank Melli Iran,Before Roshdiye cross,Azarbayegan st.
City
Tehran
Country
Iran (Islamic Republic of)

2

Recruitment center
Name of recruitment center
Meisam clinic
Full name of responsible person
Tahere Zendedel
Street address
Near meysam center,Obid zakani st,Ghapan Crossroads,Ghazvin st
City
tehran
Country
Iran (Islamic Republic of)

3

Recruitment center
Name of recruitment center
Shaheed Vahedi clinic
Full name of responsible person
Tahere Zendedel
Street address
Near the Women's Organization,Amozegar st,Yakhchi abad
City
Tehran
Country
Iran (Islamic Republic of)

Sponsors / Funding sources

1

Sponsor
Name of organization / entity
Tehran University of Medical Sciences
Full name of responsible person
Dr. Fotouhi vice chancellor for research- Tehran University of Medical Sciences
Street address
Faculty of Nursing and Midwifery, Nosrat ST,Tohid Sq.
City
Tehran
Country
Iran (Islamic Republic of)
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Tehran 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
Tehran University of Medical Sciences
Full name of responsible person
Tahereh Zendedel
Position
MS student
Other areas of specialty/work
Street address
Nosrat st. Toheid sq. Nursing &midwifery faculty
City
Tehran
Country
Iran (Islamic Republic of)
Postal code
Phone
+98 21 61054
Fax
Email
mirmohamad1@yahoo.com
Web page address

Person responsible for scientific inquiries

Contact
Name of organization / entity
Tehran University of Medical Sciences (TUMS)
Full name of responsible person
Mandana Mirmohamad aliei
Position
Instructor /MS
Other areas of specialty/work
Street address
Nosrat ST,Tohid Sq, Faculty of Nursing and Midwifery
City
Tehran
Country
Iran (Islamic Republic of)
Postal code
Phone
+98 21 61054
Fax
Email
irmohamad1@yahoo.com
Web page address

Person responsible for updating data

Contact
Name of organization / entity
Tehran University of Medical Sciences
Full name of responsible person
Tahereh Zendedel
Position
MS student
Other areas of specialty/work
Street address
Nosrat st. Toheid sq. Nursing &midwifery faculty
City
Tehran
Country
Iran (Islamic Republic of)
Postal code
Phone
+98 21 6154
Fax
Email
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
Loading...