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The assessment of Fenugreek extract's effect on early menopausal complications in symptomatic menopause women who refer to the clinic

Protocol summary

Summary
Women who refer to the clinic with the complaint of early menopause symptoms will be examined after giving consent to participating in research, and if they have inclusion criteria but not any exclusion criteria. In this study, we will use the convenient sampling and then the participants will be classified into 3 groups in the basis of random numbers. These groups are Fenugreek group, hormone therapy and placebo group. In Fenugreek extract group, two capsules each containing 500 mg extract of Fenugreek, equivalent to 6 grams of Fenugreek seeds, will be used daily (1 g total per day), after consultation with the pharmacologist and similar to analogous studies. In Hormone therapy group, two capsules containing 0/625 mg of conjugated estrogen and 2/5 mg of medroxy progesterone acetate powder will be used daily, and in the placebo group, two capsules containing lactose will be consumed daily. The duration of treatment will be 2 months. In this study, in order to evaluate the effect of the drug, climacteric Green questionnaire (Green's critical scale) will be used. In summary, before starting the study, every subject will complete two questionnaires: background variables questionnaire and Green questionnaire, and then in the fourth week and also in the eighth week after the intervention, Green questionnaire will be completed. finally, the groups’ scores, after and before treatment, will be compared together.

General information

Acronym
IRCT registration information
IRCT registration number: IRCT138811283348N1
Registration date: 2010-10-03, 1389/07/11
Registration timing: prospective

Last update:
Update count: 0
Registration date
2010-10-03, 1389/07/11
Registrant information
Name
Fatemeh Bakouei
Name of organization / entity
Midwifery group, Babol University of Medical Sciences
Country
Iran (Islamic Republic of)
Phone
+98 11 1219 0597
Email address
bakouei@mubabol.ac.ir
Recruitment status
Recruitment complete
Funding source
Babol University of Medical Sciences
Expected recruitment start date
2010-11-05, 1389/08/14
Expected recruitment end date
2011-05-20, 1390/02/30
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
The assessment of Fenugreek extract's effect on early menopausal complications in symptomatic menopause women who refer to the clinic
Public title
Effect of Fenugreek extract (Trigonella foenun-graecum) on early menopausal complications
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion Criteria: -No any menstrual bleeding experience at least during last year. -Normal blood pressure. - In evaluation of Green questionnaire, the minimum score is 15. - FSH> 40. Exclusion Criteria: -The History of known disease or abnormality (e.g, breast cancer, uterine cancer, endometrial hyperplasia, angina, heart attacks, angioplasty, blood clot, kidney disease, liver disease, thyroid disease, diabetes, migraine headaches). - Abnormal vaginal bleeding - The use of special drugs or treatments like: hormonal therapy, nervous drugs, Corticosteroids drugs and anti-clot or herbal medicine during the past 6 months. - The use of relaxation techniques during the past 6 months. - Sensitivity to spices and essential oil materials -Smoking or drinking Alcohol.
Age
From 45 years old to 65 years old
Gender
Female
Phase
3
Groups that have been masked
No information
Sample size
Target sample size: 75
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 Sciences
Street address
Ganj afroz street
City
Babol
Postal code
Approval date
2010-03-03, 1388/12/12
Ethics committee reference number
305728/ژ/پ

Health conditions studied

1

Description of health condition studied
early menopausal complications
ICD-10 code
N95.1
ICD-10 code description
Menopausal and female climacteric states

Primary outcomes

1

Description
early menopausal complications
Timepoint
before intervention, fourth and eighth weeks after intervention
Method of measurement
Greene questionnaire

Secondary outcomes

1

Description
side effects
Timepoint
fourth and eighth weeks after intervention
Method of measurement
questionnaire

Intervention groups

1

Description
Fenugreek group: two capsules each containing 500 mg Fenugreek extract, daily
Category
Treatment - Drugs

2

Description
Hormone therapy group: two capsuls containing estrogen conjugate 0.625mg and medroxy progestron acetat 2.5mg, daily
Category
Treatment - Drugs

3

Description
Placebo group: two capsules containing lactose, daily
Category
Placebo

Recruitment centers

1

Recruitment center
Name of recruitment center
Ayatollah rohani Hospital Clinic
Full name of responsible person
Dr Basirat
Street address
Ganj afroz street
City
Babol

Sponsors / Funding sources

1

Sponsor
Name of organization / entity
Babol University of Medical Sciences
Full name of responsible person
Dr Ali Bijani
Street address
Ganj afroz street
City
Babol
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Babol 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
Babol University of Medical Sciences
Full name of responsible person
Fatemeh Bakouei
Position
PHD student in reproductive health
Other areas of specialty/work
Street address
Ganj afrooz, Babol University of Medical Sciences
City
Babol
Postal code
Phone
+98 911 315 8440
Fax
Email
bakouei2004@yahoo.com
Web page address

Person responsible for scientific inquiries

Contact
Name of organization / entity
Babol University of Medical Sciences
Full name of responsible person
Dr Zahra Basirat
Position
Associate Professor
Other areas of specialty/work
Street address
Babol University of Medical Sciences, Ganj afroz street
City
Babol
Postal code
Phone
+98 911 111 2979
Fax
Email
zahra_basirat@yahoo.com
Web page address

Person responsible for updating data

Contact
Name of organization / entity
Babol University of Medical Sciences
Full name of responsible person
Fatemeh Bakouei
Position
PHD student in reproductive health
Other areas of specialty/work
Street address
Midwifery group, Babol University of Medical Sciences, Ganj afrooz St.
City
Babol
Postal code
Phone
+98 911 315 8440
Fax
Email
bakouei2004@yahoo.com
Web page address

Sharing plan

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