This study is a clinical trial designed to determine the effect of Passion flower and red clover oral capsules on sleep disorders in women aged 50-60. 120 healthy postmenopausal volunteers referred to Abuzar clinic and Women Hospital (40 persons in each group) eligible for entry (inclusion criteria: cessation of menstruation for at least 12 months due to menopause, any history of consuming alcoholic drink, smoking, addiction or any kind of hormonal drugs.) were enrolled into the study after completing the informed consent.
Exclusion criteria were any kind of physical or mental disease that appears during the study and causes sleep disorders, significant change in conditions of sleep such as traveling, anything that causes sleep disturbance during the study.
The subjects include three groups: treated with passion flower, red clover and the control group. The treatment group received 2 gr passion flower (plant leaves), or 40 mg red clover, or 40 mg starch (controls) (capsules of the same form twice a day for eight weeks). The tools of study consisted of demographic questionnaire and Pittsburgh sleep Index questionnaire recorded and compared before treatment and eight weeks after treatment.
General information
Acronym
IRCT registration information
IRCT registration number:IRCT201407092172N18
Registration date:2014-08-09, 1393/05/18
Registration timing:registered_while_recruiting
Last update:
Update count:0
Registration date
2014-08-09, 1393/05/18
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
2014-07-23, 1393/05/01
Expected recruitment end date
2015-09-23, 1394/07/01
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Effect of red clover and passion flower capsules on sleep disorder among menopausal women
Public title
Effect of red clover and passion flower capsules on sleep disorder among menopausal women
Purpose
Supportive
Inclusion/Exclusion criteria
Inclusion criteria: Women volunteers without known disease who passed through natural menopause; No history of consuming alcoholic drink, smoking, addiction or any kind of hormonal drugs. Exclusion criteria: any kind of physical or mental disease that appear during the study and causes sleeping disorders; A significant change in influential conditions on sleeping unpredictable such as traveling changing the location; Any incident during the study to make the patient sleepless.
Age
From 50 years old to 60 years old
Gender
Female
Phase
N/A
Groups that have been masked
No information
Sample size
Target sample size:
120
Randomization (investigator's opinion)
N/A
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
No 23, Dameshgh St., Valiasr Ave
City
Tehran
Postal code
Approval date
2014-06-18, 1393/03/28
Ethics committee reference number
92-02-28-23388-101905
Health conditions studied
1
Description of health condition studied
Sleep disorders
ICD-10 code
G47.0
ICD-10 code description
Disorders of initiating and maintaining sleep [insomnias]
Primary outcomes
1
Description
Score of sleeping disorder
Timepoint
Before intervention, 2monthes after intervention
Method of measurement
Pittsburgh sleeping disorder questionnaire
Secondary outcomes
empty
Intervention groups
1
Description
Intervention 1:Oral consumption of passion flower, 2gr capsule, twice a day for 2 month
Category
Treatment - Drugs
2
Description
Placebo Group: Capsule 40 mg containe starch, twice a day, for 2monthes
Category
Placebo
3
Description
Intervention 1:Oral consumption of red clover, 40 mg capsule, twice a day for 2 month
Category
Treatment - Drugs
Recruitment centers
1
Recruitment center
Name of recruitment center
Menopause Clinic of OB&GYN hospital: Jame Zanan Hospital
Full name of responsible person
Mojgan Asadi
Street address
Jame Zanan Hospital of Tehran,Above of Zamin shahri Organization, North Nejatollahi Ave, Karim Khan Zand Ave.
City
Tehran
2
Recruitment center
Name of recruitment center
Abuzar Clinic
Full name of responsible person
Maryam Maleki
Street address
Adjacent to the sports center, Abuzar square, District 17
City
Tehran
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Vice chancellor for research, Tehran University of Medical Sciences
Full name of responsible person
Esmat Karimi
Street address
No 23, Dameshgh St., Valiasr Ave
City
Tehran
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Vice chancellor for research, 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, Faculty Member & Resaercher
Other areas of specialty/work
Street address
3rd Floor, No.12, Nadjmabady St. Kazeroon St. Mirdamad Ave
City
Tehran
Postal code
Phone
+98 21 8820 8161
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, Faculty Member & Resaercher
Other areas of specialty/work
Street address
3rd Floor, No.12, Nadjmabady St. Kazeroon St. Mirdamad Ave
City
Tehran
Postal code
Phone
+98 21 8820 8161
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 & Resaercher
Other areas of specialty/work
Street address
3rd Floor, No.12, Nadjmabady St. Kazeroon St. Mirdamad Ave
City
Tehran
Postal code
Phone
+98 21 8820 8161
Fax
Email
staavoni@iums.ac.ir
Web page address
Sharing plan
Deidentified Individual Participant Data Set (IPD)