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The effects of red clover on some of menopausal symptoms and quality of life in post-menopausal women under coverage of Isfahan’s selected health care center in 2010

Protocol summary

Summary
Objective: Considering that red clover is the rich source of phytoestrogens, this clinical randomized, triple-blind, placebo-controlled trial investigated the effect of red clover on quality of life in post-menopausal women. Methods: The menopausal women, who already have been under the coverage of this center and had inclusion criteria, included the study samples. Age>45 years, Amenorrhea>12 month and<5 year duration, Kupperman Index Score15, Good general health. Able to give informed consent (Able to read and write) were main inclusion criteria and Having hormone therapy contraindications, Use of drugs that influence vasomotors symptoms, Occurrence of any serious event in the 6 months prior the study, taking the drugs that might reduce absorption of isoflavones, Consuming less than %80 of the expected capsules during one month were main non-inclusion criteria and exclusion. Seventy-two menopausal women were the study samples and after two weeks of monitoring, were randomized blindly to receive daily oral consumption one 45 mg red clover capsule or starch powder as placebo each morning with the breakfast meal for 8 weeks continued from end of the second week to end of the tenth week. The main outcomes were the menopausal symptoms and quality of life. Key Words: menopausal symptoms, phytoestrogens, quality of life, red clover.

General information

Acronym
IRCT registration information
IRCT registration number: IRCT138902263936N1
Registration date: 2012-01-08, 1390/10/18
Registration timing: retrospective

Last update:
Update count: 0
Registration date
2012-01-08, 1390/10/18
Registrant information
Name
Kobra Salehi
Name of organization / entity
Isfahan University of Medical Sciences
Country
Iran (Islamic Republic of)
Phone
+98 33 4243 2929
Email address
k_salehi@nm.mui.ac.ir
Recruitment status
Recruitment complete
Funding source
Isfahan University of Medical Sciences
Expected recruitment start date
2010-10-23, 1389/08/01
Expected recruitment end date
2011-04-21, 1390/02/01
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
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Scientific title
The effects of red clover on some of menopausal symptoms and quality of life in post-menopausal women under coverage of Isfahan’s selected health care center in 2010
Public title
The effect of red clover on menopausal symptoms
Purpose
Treatment
Inclusion/Exclusion criteria
Main Inclusion criteria: Age>45 years, Amenorrhea>12 month and<5 year duration, Kupperman Index Score15, Good general health. Able to give informed consent (Able to read and write). Main non-inclusion criteria and exclusion: Having hormone therapy contraindications, Use of drugs that influence vasomotors symptoms, Occurrence of any serious event in the 6 months prior the study, taking the drugs that might reduce absorption of isoflavones, Consuming less than %80 of the expected capsules during one month.
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: 72
Randomization (investigator's opinion)
Randomized
Randomization description
Blinding (investigator's opinion)
Triple blinded
Blinding description
Placebo
Used
Assignment
Parallel
Other design features
Other Inclusion criteria: No use of treatments such as hormone therapy, dietary supplementations, herbal therapy in the six months prior to enrollment for relieving menopause symptoms, Interest in participation in the study. Other non-inclusion criteria and exclusion: The incidence of menopause at the ages under 40 years, Current treatment or therapy in the last 3 months with any of the following drugs: anticonvulsants, antidepressants, phenothiazines, benzodiazepines, ergot derivatives, -blockers, central acting antihypertensive drugs,Vegetarian, Current participation in any other clinical trial, Disorder in the metabolism or sensitivity to estrogen or phytoestrogens (this criterion was assessed with asking the questions about record of using OCPs and incidence of any problem following the consumption of these pills).BMI 25kg/ m2, having any type of disease, Unwillingness to continue participation in the study, Occurrence of any serious event especially one that could affects the quality of life during the study, Occurrence of any potential complication during the study that could affect the subject's health. The data were collected in four phases: at the beginning of the study, at the end of the second, sixth and tenth weeks of study. Before the treatment and at the end of the study, menopause specific quality of life questionnaire (MENQOL) was completed in the two groups. Furthermore, menopausal symptoms weekly were recorded using KMI by the study subjects. The subjects were asked to bring the container at the final visit and thus the number of the remained capsules could be counted by one of the health care center’s staff who was not informed about the study process. The study subjects were explained to avoid supplements containing soy more than once a week. During the medication consumption, which continued from end of the second week to end of the tenth week, the study subjects recorded their symptoms and were phone called weekly and regular drug consumption was reminded to them. Besides, phone number of the researcher also was given to the study subjects to contact the researcher.

Secondary Ids

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Ethics committees

1

Ethics committee
Name of ethics committee
Isfahan University of Medical Sciences
Street address
Isfahan University of Medical Sciences- hezargerib st- isfahan -I.R.IRAN
City
Isfahan
Postal code
Approval date
2010-05-10, 1389/02/20
Ethics committee reference number
389039

Health conditions studied

1

Description of health condition studied
Symptoms such as flushing, sleeplessness, headache, lack of concentration, associated with menopause
ICD-10 code
N95.1
ICD-10 code description
Menopausal and female climacteric

Primary outcomes

1

Description
Menopausal symptoms
Timepoint
Before the intervention (treatment), 4 and 8 weeks after beginning the intervention
Method of measurement
Kupperman menopausal index

2

Description
Quality of life
Timepoint
Before the intervention (treatment) and 8 weeks after beginning the intervention
Method of measurement
Menopause -specific quality of life questionnaire

Secondary outcomes

empty

Intervention groups

1

Description
Daily oral consumption one 45 mg red clover capsule each morning with the breakfast meal for 8 weeks continued from end of the second week to end of the tenth week.
Category
Treatment - Drugs

2

Description
In the control group: Daily oral consumption one 45 mg starch powder capsule each morning with the breakfast meal for 8 weeks continued from end of the second week to end of the tenth week.
Category
Placebo

Recruitment centers

1

Recruitment center
Name of recruitment center
Navab Safavi Health Care Center affiliated to Isfahan University of Medical Sciences.
Full name of responsible person
kobra salehi
Street address
City
Isfahan

Sponsors / Funding sources

1

Sponsor
Name of organization / entity
Isfahan University of Medical Sciences.
Full name of responsible person
Vice chancellor for research, Isfahan University of Medical Sciences.
Street address
Hazar garib avenue
City
Isfahan
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Isfahan 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
Isfahan University of Medical Sciences.
Full name of responsible person
Kobra Salehi
Position
MSC IN midwifery
Other areas of specialty/work
Street address
Isfahan University of Medical SciencesHazar jarib ave.
City
Isfahan
Postal code
Phone
+98 33 4243 2929
Fax
Email
k_salehi@nm.mui.ac.ir
Web page address

Person responsible for scientific inquiries

Contact
Name of organization / entity
Isfahan University of Medical Sciences
Full name of responsible person
Kobra Salehi
Position
MSC
Other areas of specialty/work
Street address
Isfahan university of medical sciences-ISFAHAN- IRAN
City
Isfahan
Postal code
Phone
+98 33 4243 2929
Fax
Email
k_salehi@nm.mui.ac.ir
Web page address

Person responsible for updating data

Contact
Name of organization / entity
Isfahan University of Medical Sciences
Full name of responsible person
Kobra Salehi
Position
Isfahan university of medical sciences
Other areas of specialty/work
Street address
City
Isfahan
Postal code
Phone
+98 33 4243 2929
Fax
Email
k_salehi@nm.mui.ac.ir
Web page address

Sharing plan

Deidentified Individual Participant Data Set (IPD)
empty
Study Protocol
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Statistical Analysis Plan
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Informed Consent Form
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Clinical Study Report
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Analytic Code
empty
Data Dictionary
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