Comparison of the effect of Foeniculum vulgare and St John’s wort (Hypericum perforatum) on the climacteric symptoms and sexual activity in menopausal woman attending in selected gynecology clinics of shiraz university of medical sciences,1391.
The present clinical, randomized, single-blind, placebo-controlled trial aimed to determine the effect of Foeniculum vulgare and St John’s wort on the climacteric symptoms and sexual dysfunction in menopausal women. The study population included the menopausal women from 45 to 60 years old attending the selected gynecology clinics of Shiraz University of Medical Sciences which had agreed to cooperate with the researchers. The study subjects were also required to have the following criteria: at least 12 months being passed from their last menstrual, FSH more than40. In case the study subjects suffered from any illness, were not willing to continue participating in the study, and showed allergic reactions to medication, they were excluded from the study. After all, a total of 105 subjects were entered into the study and randomly divided in to three groups of 35 receiving the drug and the placebo, respectively for 8 weeks.climacteric complaints were evaluated using Green climacteric scale and Female Sexual Function Index at two follow up visits.
General information
Acronym
IRCT registration information
IRCT registration number:IRCT201207281548N15
Registration date:2012-08-25, 1391/06/04
Registration timing:registered_while_recruiting
Last update:
Update count:0
Registration date
2012-08-25, 1391/06/04
Registrant information
Name
Khadijeh Abdali
Name of organization / entity
Fatemeh college of nursing and midwifery, Shiraz University of Medical Sciences
Country
Iran (Islamic Republic of)
Phone
+98 71 1647 4255
Email address
abdalikh@sums.ac.ir
Recruitment status
Recruitment complete
Funding source
Deputy of Research of Shiraz University of Medical Sciences
Expected recruitment start date
2012-08-22, 1391/06/01
Expected recruitment end date
2012-12-21, 1391/10/01
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Comparison of the effect of Foeniculum vulgare and St John’s wort (Hypericum perforatum) on the climacteric symptoms and sexual activity in menopausal woman attending in selected gynecology clinics of shiraz university of medical sciences,1391.
Public title
Evaluation of the effect of two herbal medicine on the climacteric symptoms and sexual activity in menopausal women
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria: having general health according to the Goldberg's questionnaire; i.e., getting under23 score, being married and between 40 and 60 years old, not using vitamin supplements, not using soya, not having used hormone therapy during the last 3 months, not using anti-depression,and tranquilizer drugs, amenorrhea for at least 6 months, and FSH more than 40. Exclusion criteria: Suffering from liver, kidney, and digestive diseases, inability to continue taking medication for any reason, unwillingness to cooperate after the beginning of the study, and showing allergic reactions to medication.
Age
From 45 years old to 60 years old
Gender
Female
Phase
N/A
Groups that have been masked
No information
Sample size
Target sample size:
105
Randomization (investigator's opinion)
Randomized
Randomization description
Blinding (investigator's opinion)
Single blinded
Blinding description
Placebo
Used
Assignment
Parallel
Other design features
Secondary Ids
empty
Ethics committees
1
Ethics committee
Name of ethics committee
The Medical Research Ethics Committee of Shiraz University of Medical Sciences
Street address
zand sq
City
shiraz
Postal code
Approval date
2012-07-10, 1391/04/20
Ethics committee reference number
ct-91-6109
Health conditions studied
1
Description of health condition studied
menopause
ICD-10 code
N95.1
ICD-10 code description
Symptoms such as flushing, sleeplessness, headache, lack of concentration, associated with menopause
Primary outcomes
1
Description
Improvement of clinical symptoms
Timepoint
4 weeks
Method of measurement
Green Questionnaire
Secondary outcomes
1
Description
Improve sexual function
Timepoint
4 weeks
Method of measurement
Female Sexual Function Index
Intervention groups
1
Description
Oral placebo tablets three times daily for 8 weeks
Category
Placebo
2
Description
Fennel, soft capsule, 30 mg orally, three times daily for 8 weeks
Category
Treatment - Drugs
3
Description
Hypericum perforatum,160 mg oral tablet, three times daily for 8 weeks
Category
Treatment - Drugs
Recruitment centers
1
Recruitment center
Name of recruitment center
outpatient academic medical center of Zeynabiyeh Hospital
Full name of responsible person
Street address
City
shiraz
2
Recruitment center
Name of recruitment center
outpatient academic medical center of Hafez Hospital
Full name of responsible person
Street address
City
shiraz
3
Recruitment center
Name of recruitment center
outpatient academic medical center of Shahid Faghihi Hospital
Full name of responsible person
Street address
City
shiraz
4
Recruitment center
Name of recruitment center
Motahhari Clinic
Full name of responsible person
Street address
City
shiraz
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Shiraz University of Medical Sciences
Full name of responsible person
Dr Gholam Reza Hattam
Street address
Deputy for Research, seventh Floor, the central structure of Shiraz University of Medical Sciences, next to the Red Crescent, Zand Avenue
City
shiraz
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Shiraz 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
Fatemeh College of nursing and midwifery
Full name of responsible person
Khadijeh Abdali
Position
Master's degree in midwifery, faculty member
Other areas of specialty/work
Street address
Namazi sq
City
shiraz
Postal code
Phone
+98 71164742547
Fax
Email
abdalikh@sums.ac.ir
Web page address
Person responsible for scientific inquiries
Contact
Name of organization / entity
School of Medicine
Full name of responsible person
Dr Maray Kasrain
Position
Assistant Professor, Perinatology Fellowship
Other areas of specialty/work
Street address
School of Medicine, Imam Hossein Square, Zand Avenue
City
shiraz
Postal code
Phone
+98 71 1230 5410
Fax
Email
kasraeem@yahoo.com
Web page address
Person responsible for updating data
Contact
Name of organization / entity
Fatemeh (PBUH) College of Nursing and Midwifery, Shiraz
Full name of responsible person
paria dowran
Position
Master's degree in Midwifery
Other areas of specialty/work
Street address
Namazi Sq
City
shiraz
Postal code
Phone
+98 71164742528
Fax
Email
Web page address
Sharing plan
Deidentified Individual Participant Data Set (IPD)