The randomized control clinical trial will conducted to assess the effect of red clover on severity menopausal symptoms.
Inclusion Criteria: Naturally menopausal women with 50-59 years old; Negative history of physical and psychological disease; Negative history of hormone therapy and herbal medicine; Stop using red clover and placebo for days in 1 month; Allergy to red clover.
Following approval of proposed study design, The study sample of 110 women, who had entered the menopausal period naturally and referred to Tehran university clinics, will be assigned randomly into two groups, test group who will receive two capsules of red clover per day for 90 day period, or the control group who will receive the equal design of placebo capsules. Formal contest will be taken from all participants at beginning. The output measures include menopausal symptoms, as obtain through the Menopause Rating Scale. Four MRS score will be obtained through the study for every participants ( before intervention and during the first, second third month of intervention) and the severity of menopausal symptom will be evaluated.
General information
Acronym
IRCT registration information
IRCT registration number:IRCT201112172172N13
Registration date:2012-02-02, 1390/11/13
Registration timing:registered_while_recruiting
Last update:
Update count:0
Registration date
2012-02-02, 1390/11/13
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
Vice chancellor for research, Tehran University of Medical Sciences
Expected recruitment start date
2011-12-22, 1390/10/01
Expected recruitment end date
2012-04-19, 1391/01/31
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Evaluation of the effect of oral red clover drug on the severity of menopausal symptoms of 50-59 yeares old women attendant to menopausal clinic.
Public title
Effect of Red Clover on menopausal symptoms.
Purpose
Supportive
Inclusion/Exclusion criteria
Inclusion criteria : naturally menopausal women, 50-59 years old; Negative history of cancer; Negative history of physical and psychological disease; Negative history of hormone therapy and herbal medicine; Negative history of allergy to Red Clover, Soy bean and other herbal medicine.
Exclusion criteria: Under medication by hormone therapy, antibiotic or anti acid (due to inhibition of herbal medicine absorption); Starting any type of herbal medication more than once a week during the study; Starting vegetarian diet during the study; allergy to Red Clover during the intervention; Poor cooperation during the study Stop using Red Clover/placebo for 6 day in 1 month; Obese women with BMI>38kg/m2
Age
From 50 years old to 59 years old
Gender
Female
Phase
N/A
Groups that have been masked
No information
Sample size
Target sample size:
110
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 Department
Street address
No 23, Dameshgh St., Valiasr Ave
City
Tehran
Postal code
Approval date
2011-12-18, 1390/09/27
Ethics committee reference number
15265
Health conditions studied
1
Description of health condition studied
Menopausal symptoms
ICD-10 code
N95.1
ICD-10 code description
Menopausal and female climacteric states
Primary outcomes
1
Description
Severity of Menopausal symptoms scores
Timepoint
Before intervention, at the end of first, second and third of intervention after intervention
Method of measurement
Menopausal Rating Scale
Secondary outcomes
1
Description
Severity of physical symptom scores.
Timepoint
Before intervention, at the end of first, second and third of intervention after intervention
Method of measurement
Menopausal Rating Scale
2
Description
Severity psychological symptome score
Timepoint
Before the intervention,at the end of first, second and third of intervention
Method of measurement
Menopause Rating Scale
3
Description
Severity of urogental symptom score
Timepoint
Before the intervention,at the end of first,second and third of intervention
Method of measurement
Menopause Rating Scale
Intervention groups
1
Description
Intervention 1:Oral administration 40 mg Red clovercapsule, twice a day for 3 month