Protocol summary

Summary
In postmenopausal women, the level of sex hormones changes due to the end of ovarian function. Because of the significant and varied effects of sex hormones, especially Estrogen, on the central nervous system, bone, heart, liver and skin, the effect of these hormonal changes on the different aspects of women's health is significant and important. In postmenopausal women, phytoestrogens can act as an estrogenic agonist. Elaeagnus angustifolia L. or Russian olive, have a lot of valuable compounds. Although its efficacy has been studied in various cases, such as Rheumatoid arthritis, Gastric ulcer, etc., its effect has not yet been studied in postmenopausal women. This research is performed by simple random sampling of two intervention and control groups. In the initial assessment, blood pressure, heart rate, and lipid profiles of individuals are measured. In each group, there are 30 menopausal women aged 45-70, living in the Alborz province who will receive 15 grams of drug (full-grain Elaeagnus angustifolia L. powder) and placebo (combined with 7.5 grams of Corn Starch and 7.5 grams of Isomalt) per day for 10 weeks each day in parallel. Postmenopausal women with cardiovascular, renal and metabolic diseases, such as diabetes, as well as women who use psychosocial drugs or cigarettes, hookahs, alcoholic and narcotic drugs, or serum lipid levels of 200-300 mg/ml , will be excluded. The Estrogen, Progesterone, Testosterone, FSH and LH levels will be investigated at the beginning and at the end of this ten week period.

General information

Acronym
IRCT registration information
IRCT registration number: IRCT2017030932795N2
Registration date: 2017-09-11, 1396/06/20
Registration timing: registered_while_recruiting

Last update:
Update count: 0
Registration date
2017-09-11, 1396/06/20
Registrant information
Name
Arezou Rezaei
Name of organization / entity
Damghan university
Country
Iran (Islamic Republic of)
Phone
+98 23 3522 0081
Email address
arezaei@du.ac.ir
Recruitment status
Recruitment complete
Funding source
Research deputy of Damghan UniversityResearch deputy of Alborz University
Expected recruitment start date
2017-08-05, 1396/05/14
Expected recruitment end date
2017-10-23, 1396/08/01
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Effects of Elaeagnus angustifolia L. on the sex hormone profiles in menopause women
Public title
Effects of Elaeagnus angustifolia L. on the sex hormone profiles in menopause women
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria: All women aged 40-70 with serum lipid levels of 200-300 mg/dl without any risk factor for not using medicine to decrease the lipid level are included in this trial. Exclusion criteria: The women who suffer from ccardiovascular diseases, renal and metabolic disorders such as diabetes, those using psychiatric drugs, smoking tobacco or consuming alcohol or narcotic agents are excluded from the study
Age
From 40 years old to 70 years old
Gender
Female
Phase
2-3
Groups that have been masked
No information
Sample size
Target sample size: 60
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
Alborz University of Medical Sciences
Street address
Alborz University of Medical Sciences, Administrative City, North Taleghani avenue, Karaj, Alborz
City
Karaj
Postal code
Approval date
2017-07-25, 1396/05/03
Ethics committee reference number
Abzums.Rec. 1396.88

Health conditions studied

1

Description of health condition studied
Menopause
ICD-10 code
N95.9
ICD-10 code description
Menopausal and perimenopausal disorder, unspecified

Primary outcomes

1

Description
Estradiol
Timepoint
Before the start of the trial and 10 weeks after taking the drug or placebo
Method of measurement
Standards of medical Diagnostic Laboratories

2

Description
Progesterone
Timepoint
Before the start of the trial and 10 weeks after taking the drug or placebo
Method of measurement
Standards of medical Diagnostic Laboratories

3

Description
Testosterone
Timepoint
Before the start of the trial and 10 weeks after taking the drug or placebo
Method of measurement
Standards of medical Diagnostic Laboratories

4

Description
FSH (Follicle stimulating hormone)
Timepoint
Before the start of the trial and 10 weeks after taking the drug or placebo
Method of measurement
Standards of medical Diagnostic Laboratories

5

Description
LH (Luteinizing hormone)
Timepoint
Before the start of the trial and 10 weeks after taking the drug or placebo
Method of measurement
Standards of medical diagnostic Laboratories

Secondary outcomes

1

Description
Constipation
Timepoint
After the start of the trial and up to 10 weeks after taking the drug
Method of measurement
Questionnaire and weekly phone calls

2

Description
Abdominal Pain
Timepoint
After the start of the trial and up to 10 weeks after taking the drug
Method of measurement
Questionnaire and weekly phone calls

Intervention groups

1

Description
Intervention group:Elaeagnus angustifolia L powder, 15 g / day
Category
Treatment - Drugs

2

Description
Control group (placebo): 7.5 g Isomalt and 7.5 g Corn starch / day
Category
Treatment - Drugs

Recruitment centers

1

Recruitment center
Name of recruitment center
Kamali Clinic
Full name of responsible person
Dr. Bita Badehnoosh
Street address
City
Karaj

Sponsors / Funding sources

1

Sponsor
Name of organization / entity
Damghan University- َAlborz University
Full name of responsible person
Arezou Rezaei, Bita Badehnoosh
Street address
Damghan University, University Square, Damghan city / Alborz University of Medical Sciences, Administrative City, Taleghani square, karaj
City
Damghan, Karaj
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Damghan University- َAlborz University
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
Damghan University
Full name of responsible person
Farzaneh Emami Nia
Position
Masters student
Other areas of specialty/work
Street address
College of Biology, University of Damghan, University Square, Damghan
City
Damghan
Postal code
Phone
+98 21 7744 7318
Fax
Email
farzaneh.emaminia@gmail.com
Web page address

Person responsible for scientific inquiries

Contact
Name of organization / entity
Damghan University , Alborz University of Medical Sciences
Full name of responsible person
ِDr.Arezou Rezaei , Dr.Bita Badehnoosh
Position
Doctor of Biochemistry, Obstetrics and Gynecology
Other areas of specialty/work
Street address
College of Biology, University of Damghan, Damghan Square ,Damghan / Alborz University of Medical Sciences, North Taleghani avenue, Taleghni Square , Karaj, Alborz
City
Damghan / Karaj
Postal code
Phone
+98 912 332 5792
Fax
Email
arezaei@du.ac.irbadehnoosh@abzums.ac.ir
Web page address

Person responsible for updating data

Contact
Name of organization / entity
Damghan University
Full name of responsible person
Arezou Rezaei
Position
Biochemistry PhD
Other areas of specialty/work
Street address
Damghan University
City
Damghan
Postal code
Phone
00
Fax
Email
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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