Protocol summary

Summary
The objective of the study is to assess the effect of valerian root extract, lemon balm and combination of valerian/lemon balm on sleep disturbances in menopausal women referred to selected health centers affiliated to Tehran University of Medical Sciences. More than 400 volunteered menopausal women will be interviewed using Pittsburg Sleep Quality Index Questionnaire (PSQI). A total of 200 women of those who scored 5 or more will be invited to participate in the study and sign a written informed consent form. The participants will be randomly assigned into three intervention groups and a control group. The participants in the intervention groups will receive Sedamin, 530 mg capsule, Lemon Balm, 250 mg capsule, or Noragol (160 mg valerian and 80 mg lemon balm), twice daily for a month and those who are in the control group will receive placebo capsule, at the same dose as the intervention groups. Pittsburg Sleep Quality Index questionnaire score will be measured and compared for all participants before and one month after the intervention.

General information

Acronym
Effect of lemon balm, valerian and valerian/lemon balm on menopause womens
IRCT registration information
IRCT registration number: IRCT201106302172N10
Registration date: 2011-07-10, 1390/04/19
Registration timing: prospective

Last update:
Update count: 0
Registration date
2011-07-10, 1390/04/19
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
Tehran University of Medical Sciences
Expected recruitment start date
2011-07-23, 1390/05/01
Expected recruitment end date
2011-12-22, 1390/10/01
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Effect of lemon balm, valerian and valerian/lemon balm on menopause women, sleep disorder in clients visited in health care clinics of Tehran university of Medical Science (2010)
Public title
Effect of lemon balm, valerian and valerian/lemon balm on menopause women, sleep disorder in clients visited in health care clinics of Tehran university of Medical Science (2010)
Purpose
Supportive
Inclusion/Exclusion criteria
Inclusion criteria: Not having physical or psychological diseases which may cause sleep problems, Not to use tobacco, drugs or alcohol Exclusion criteria: Appearance of any physical illness and psychological disorder during the study period, 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
N/A
Groups that have been masked
None
Sample size
Target sample size: 200
Randomization (investigator's opinion)
Randomized
Randomization description
Blinding (investigator's opinion)
Triple blinded
Blinding description
Placebo
Used
Assignment
Parallel
Other design features

Secondary Ids

empty

Ethics committees

1

Ethics committee
Name of ethics committee
Tehran University of Medical Sciences
Street address
Tehran University of Medical Sciences, Qods Ave., Keshavarz Boulevard
City
Tehran
Country
Iran (Islamic Republic of)
Postal code
Approval date
2011-06-07, 1390/03/17
Ethics committee reference number
89-04-28-11933

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 1: Sedamin, 530 mg capsule, twice daily for one month
Category
Treatment - Drugs

2

Description
Intervention group 2: Lemon balm, 250 mg capsule, twice daily for one month
Category
Treatment - Drugs

3

Description
Intervention group 3: Noragol, 160 mg valerian and 80 mg lemon balm capsule, twice daily for one month
Category
Treatment - Drugs

4

Description
Control group: placebo, 50 mg capsule, twice daily for one month
Category
Treatment - Drugs

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
Qods
Country
Iran (Islamic Republic of)

2

Recruitment center
Name of recruitment center
Emam Hossein 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
Qods
Country
Iran (Islamic Republic of)

Sponsors / Funding sources

1

Sponsor
Name of organization / entity
Vice chancellor for reasearch, Tehran University of Medical Sciences
Full name of responsible person
dr.fotoohi
Street address
Tehran University of Medical Sciences, Qods Ave., Keshavarz Boulevard
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
Vice chancellor for reasearch, 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
Nursing and Midwifery Faculty, Tehran 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
+98 21 6692 1228
Fax
Email
staavoni14@yahoo.com
Web page address

Person responsible for scientific inquiries

Contact
Name of organization / entity
Nursing and Midwifery Faculty, Tehran 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
+98 21 4687 0263
Fax
Email
staavoni14@yahoo.com
Web page address

Person responsible for updating data

Contact
Name of organization / entity
Nursing and Midwifery Faculty, Tehran 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
City
Tehran
Country
Iran (Islamic Republic of)
Postal code
1919915375
Phone
+98 21 6692 1228
Fax
Email
staavoni14@yahoo.com
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
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