Objective: To compare the efficacy and safety of St John's wort with placebo in outpatients with hot flashes. Methods: 100 menopausal women participated in a clinical trial conducted in several academic medical centers in Shiraz-Iran. Patients were treated with St. John’s wort extract or placebo for 8 weeks. Climacteric complaints were evaluated using Kupperman Index at two follow up visits.
General information
Acronym
IRCT registration information
IRCT registration number:IRCT138710241548N1
Registration date:2009-09-09, 1388/06/18
Registration timing:retrospective
Last update:
Update count:0
Registration date
2009-09-09, 1388/06/18
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 for Research of Shiraz University of Medical Sciences
Expected recruitment start date
2008-11-09, 1387/08/19
Expected recruitment end date
2009-03-09, 1387/12/19
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
The effect of St John's Wort on severity, frequency and duration of hot flashes in peri and postmenopausal women
Public title
Evaluation of the effect of an herbal medication on severity, frequency and duration of hot flashes in menopausal women
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria: (1) natural perimenopuse (3-11 months of amenorrhea or increased menstrual irregularity if still cycling) or postmenopause (12 or more months of amenorrhea) (2) untreated complaints for at least 2 months, (3) no history of cancer, (4) moderate to severe hot flashes happening at least once a day, (5) lack of illnesses creating hot flash-like symptoms, (6) presenting the serum level of FSH more than 40 mlu/ml. Exclusion criteria: (1) treatment with sexual hormones, nonhormonal climacteric drugs, or any treatment to alleviate climacteric symptoms in the last 12 weeks before study entry, (2) treatment with chemical or plant-derived medicines in the last 12 weeks before study entry, (3) bilateral oophorectomy, and (4) severe diseases (e.g., of the heart, liver, kidney, alimentary system, or metabolic diseases) or abnormal thyroid-stimulating hormone value that could mimic climacteric complaints or the actual or expected treatment or that could interfere with the study objectives.
Age
From 45 years old to 60 years old
Gender
Female
Phase
2
Groups that have been masked
No information
Sample size
Target sample size:
100
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
The Medical Research Ethics Committee of Shiraz University of Medical Sciences
Street address
Zand sq.
City
Shiraz
Postal code
Approval date
empty
Ethics committee reference number
87-4288
Health conditions studied
1
Description of health condition studied
Hot flashes in peri and postmenopausal women
ICD-10 code
N95.1
ICD-10 code description
Menopausal and female climacteric states
Primary outcomes
1
Description
decrease of the severity, frequency and duration of hot flashes
Timepoint
one month
Method of measurement
Kupperman Index
Secondary outcomes
empty
Intervention groups
1
Description
placebo: 20 drops,three times daily for 2 months
Category
Placebo
2
Description
Hypiran: 20 drops, three times daily for 2 months
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
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Deputy of Research of Shiraz University of Medical Sciences
Full name of responsible person
Dr. Mohammad Hosein Dabbagh Manesh
Street address
Zand st.
City
Shiraz
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Deputy of Research of 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
Person responsible for scientific 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 updating data
Contact
Name of organization / entity
Full name of responsible person
Khadijeh Abdali
Position
Other areas of specialty/work
Street address
City
Postal code
Phone
Fax
Email
Web page address
Sharing plan
Deidentified Individual Participant Data Set (IPD)