This double blind randomized clinical trial includes 100 post menopausal syndrome patients who are referred to reproductive health research center. The Score Card Scale is used to assess the frequency and severity of menopausal symptoms. With regards to menopausal symptoms, the women are asked if they had experienced 20 symptoms in the last two weeks and grade its severity as mild, moderate or severe. Pelvic ultrasound or normal Pelvic exame and blood sample for serum FSH was taken at baseline of the treatment or two years of lmp. The informed consent is obtained from patients. Patients are divided randomly in two treatment groups. One group receive chamomile capsule (400 mg with apajeninie1.2% for QID) and the other one receive placebo capsule for 12 weeks. The Score Card Scale is evaluated after 4, 8, 12 weeks treatment again.
General information
Acronym
IRCT registration information
IRCT registration number:IRCT138902203902N1
Registration date:2011-03-06, 1389/12/15
Registration timing:prospective
Last update:
Update count:0
Registration date
2011-03-06, 1389/12/15
Registrant information
Name
Farideh Mohsenzadeh
Name of organization / entity
Babol university of medical sciences
Country
Iran (Islamic Republic of)
Phone
+98 11 1229 8582
Email address
f.mohsenzadeh@mubabol.ac.ir
Recruitment status
Recruitment complete
Funding source
Babol University of Medical Sciences
Expected recruitment start date
2011-03-20, 1389/12/29
Expected recruitment end date
2012-12-20, 1391/09/30
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
the effect of chamomilla on early menopausal complications in menopausal women: (A double blind randomized controlled trial)
Public title
Assessment the effect of chamomilla on early menopausal complications in menopausal women
Purpose
Treatment
Inclusion/Exclusion criteria
nclusion criteria: A total score of more than 15 (means that the women needs a hormone replacement therapy), normal pelvic ultrasound or normal pelvic exam , and FSH>40 or two years of lmp. Exclusion criteria: Women who received hormone therapy during the last 6 months, on a diet or herbal treatment; hypercholesterolemia, thyroid disorders, hypertension, diabetes, family history of heart disease, cigarette smoking, serious illnesses (malignancy)
Age
From 47 years old to 62 years old
Gender
Female
Phase
3
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
Babol university of medical sceinces
Street address
Babol university of medical sceinces
City
Babol
Postal code
4713838149
Approval date
2010-06-25, 1389/04/04
Ethics committee reference number
30804
Health conditions studied
1
Description of health condition studied
menopause complication
ICD-10 code
N95.1
ICD-10 code description
Menopausal and female climacteric states
Primary outcomes
1
Description
Reduce of menopause complications
Timepoint
4 & 8 &12 weeks later
Method of measurement
Scorecard Scale
Secondary outcomes
1
Description
Enjoyed life
Timepoint
4&8&12weeks later
Method of measurement
Scorecard Scale
Intervention groups
1
Description
Intervention group: 4 100mg-caps of chamomilla, daily for 12 weeks
Category
Treatment - Drugs
2
Description
Control group: 4 caps of placebo, daily for 12 weeks
Category
Placebo
Recruitment centers
1
Recruitment center
Name of recruitment center
Babol university of medical sciences
Full name of responsible person
Farideh mohsenzadeh
Street address
Babol university of medical sciences
City
Babol
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Babol university of medical sciences
Full name of responsible person
Amrollah Mostafazadeh
Street address
Babol university of medical sciences
City
Babol
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?