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Effect of Valerian on some menopausal symptoms of the women referred to Shahrekord health centers

Protocol summary

Summary
The aim of this study was to determine the effect of Valerian on some menopausal symptoms of the women referred to Shahrekord health centers. This study was a double blinded clinical trial study with random allocation. The population of the study was the women referred to Shahrekord health centers. The women with menopausal symptoms were included into the study. Women with pheochromocytoma, carcinoid syndrome, leukemia, pancreatic tumors, thyroid anomalies, diabetes, alcohol withdrawal, epilepsy, tuberculosis and other chronic infections were excluded. Also patients who were under treatment with hormone therapy or psychotropic drugs due to mental disorders, and women with body mass index more than 29 were excluded. Sixty patients were randomly allocated in Valerian or placebo (control) groups (30 in each group). In the intervention group, women were treated with Valerian (350 mg capsules produced by Herbi Darou Iranian pharmaceutical company) each 12 hours for two months, and in the control group, participants were treated by the placebo capsule same as Valerian with the same therapeutic regimen. The Hamilton anxiety rating scale and Beck depression inventory were evaluated at the beginning and the end of the study.

General information

Acronym
IRCT registration information
IRCT registration number: IRCT201604172085N16
Registration date: 2016-05-03, 1395/02/14
Registration timing: retrospective

Last update:
Update count: 0
Registration date
2016-05-03, 1395/02/14
Registrant information
Name
Neda Parvin
Name of organization / entity
Shahrekord University of Medical Sciences
Country
Iran (Islamic Republic of)
Phone
+98 38 1333 5652
Email address
nedali285@skums.ac.ir
Recruitment status
Recruitment complete
Funding source
Shahrekord University of Medical Sciences
Expected recruitment start date
2005-12-10, 1384/09/19
Expected recruitment end date
2006-12-10, 1385/09/19
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Effect of Valerian on some menopausal symptoms of the women referred to Shahrekord health centers
Public title
Effect of Valerian on some menopausal symptoms of the women referred to Shahrekord health centers
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria: menopausal symptoms, aged 45 to 65 years Exclusion criteria: Women affected by pheochromocytoma, carcinoid syndrome, leukemia, pancreatic tumors, thyroid anomalies, diabetes, alcohol withdrawal, epilepsy, tuberculosis and other chronic infections, under treatment with hormone therapy or psychotropic drugs due to mental disorders, and body mass index more than 29
Age
From 45 years old to 65 years old
Gender
Female
Phase
N/A
Groups that have been masked
No information
Sample size
Target sample size: 60
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
Shahrekord University of Medical Sciences
Street address
Rahmatiee, Shahrekord University of Medical Sciences, Shahrekord
City
Shahrekord
Postal code
Approval date
2005-12-09, 1384/09/18
Ethics committee reference number
18-9-1384

Health conditions studied

1

Description of health condition studied
Menopause
ICD-10 code
N95.1
ICD-10 code description
Menopausal and female climacteric states

Primary outcomes

1

Description
Depression
Timepoint
At the beginning and the end of the study
Method of measurement
The Beck depression inventory

2

Description
Anxiety
Timepoint
At the beginning and the end of the study
Method of measurement
The Hamilton anxiety rating scale

Secondary outcomes

empty

Intervention groups

1

Description
Intervention group: In the intervention group, women were treated with Valerian (350 mg capsules produced by Herbi Darou Iranian pharmaceutical company) each 12 hours for two months.
Category
Treatment - Drugs

2

Description
Control group: In the control group, women were treated by the placebo capsule same as Valerian with the same therapeutic regimen.
Category
Treatment - Drugs

Recruitment centers

1

Recruitment center
Name of recruitment center
Health centers of Shahrekord
Full name of responsible person
Neda Parvin
Street address
City
Shahrekord

Sponsors / Funding sources

1

Sponsor
Name of organization / entity
Shahrekord University of Medical Sciences
Full name of responsible person
Dr.Sayed Kamal Solati
Street address
Shahrekord University of Medical Sciences, Kashani Street, Shahrekord
City
Shahrekord
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Shahrekord 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
Shahrekord University of Medical Sciences
Full name of responsible person
Neda Parvin
Position
Lecturer, faculty member
Other areas of specialty/work
Street address
Rahmatiee, Shahrekord University of Medical Sciences, Shahrekord
City
Shahrekord
Postal code
Phone
+98 38333335652
Fax
Email
np285@yahoo.com
Web page address

Person responsible for scientific inquiries

Contact
Name of organization / entity
Shahrekord University of Medical Sciences
Full name of responsible person
Neda Parvin
Position
Lecturer, faculty member
Other areas of specialty/work
Street address
Rahmatiee, Shahrekord University of Medical Sciences, Shahrekord
City
Shahrekord
Postal code
Phone
+98 38333335652
Fax
Email
np285@yahoo.com
Web page address

Person responsible for updating data

Contact
Name of organization / entity
Shahrekord University of Medical Sciences
Full name of responsible person
Neda Parvin
Position
Lecturer, faculty member
Other areas of specialty/work
Street address
Rahmatiee, Shahrekord University of Medical Sciences, Shahrekord
City
Shahrekord
Postal code
Phone
+98 38333335652
Fax
Email
np285@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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