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Study of the effects of Elaeagnus angustifolia L. fruit on the profile of hormones and lipids and genital infectious in menopausal women refer to Kamali hospital in 1396

Protocol summary

Study aim
Determination of the effects of Elaeagnus angustifolia L. fruit on the profile of hormones and lipids and genital infectious in menopausal women.
Design
A clinical trial with a parallel control group, double blind, randomized.
Settings and conduct
Parallelو Double-blind, Kamali Clinic
Participants/Inclusion and exclusion criteria
Inclusion criteria: Postmenopausal women aged 70-40 with a serum lipid level of 200-300 mg / ml and no risk factor for using the drug to lower this lipid level are invited to this study. Major exclusion criteria: The women who suffering from cardiovascular 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
Intervention groups
Intervention group: Elaeagnus angustifolia L powder, 15 g / day longer 10 weeks. Control group(placebo):7.5 g isomalt and 7.5 g corn starch longer 10 weeks.
Main outcome variables
Estradiol, Progesterone, Testosterone, FSH and LH, TSH, Prolactin, Cortisol, DHEA-SO4, Insulin, FBS, Hemoglobin A1c, Total protein, Vitamin D, Pap smear, Urine analysis and culture, Blood pressure and Heart rate, LDL, HDL, Triglyceride, Cholesterol and Vaginal culture.

General information

Reason for update
Acronym
IRCT registration information
IRCT registration number: IRCT20170227032795N4
Registration date: 2018-07-26, 1397/05/04
Registration timing: registered_while_recruiting

Last update: 2018-07-26, 1397/05/04
Update count: 0
Registration date
2018-07-26, 1397/05/04
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
Expected recruitment start date
2017-08-05, 1396/05/14
Expected recruitment end date
2017-10-23, 1396/08/01
Actual recruitment start date
2017-08-05, 1396/05/14
Actual recruitment end date
2018-10-02, 1397/07/10
Trial completion date
empty
Scientific title
Study of the effects of Elaeagnus angustifolia L. fruit on the profile of hormones and lipids and genital infectious in menopausal women refer to Kamali hospital in 1396
Public title
Study of the effects of Elaeagnus angustifolia L. fruit on the profile of hormones and lipids and genital infectious in menopausal women
Purpose
Prevention
Inclusion/Exclusion criteria
Inclusion criteria:
Postmenopausal women aged 40-70. Serum lipid level of 200-300 mg / ml. No risk factor for using the drug to lower this lipid level.
Exclusion criteria:
Cardiovascular diseases. Renal diseases. Metabolic disorders such as diabetes. Those using psychiatric drugs. Having destructive habits like cigarettes, hookahs, consuming alcohol and drugs.
Age
From 40 years old to 70 years old
Gender
Female
Phase
2-3
Groups that have been masked
  • Participant
  • Care provider
  • Investigator
  • Outcome assessor
  • Data analyser
  • Data and Safety Monitoring Board
Sample size
Target sample size: 120
Actual sample size reached: 60
Randomization (investigator's opinion)
Randomized
Randomization description
Simple random sampling method was used to randomize distribution of subjects in two groups of intervention and control group. The numbers 1 to 60 were written in the same color and shape paper. The paper was put in a pot after folding. Then the bowl components were stirred. By the person who did not have a role in this project, the paper was taken randomly. The first 30 numbers that came out of the bowl were intended for people who are supposed to be in the blue group.The 30 numbers remained in the bowl, the red group was considered.
Blinding (investigator's opinion)
Double blinded
Blinding description
By the person who does not play a role in this project, the coordination of drug and placebo packaging is performed in two packages with different color schemes. Supervisors and project students, as well as those involved in clinical trials, are unaware of the nature of these packages until the end of the design and receiving the latest test results and analysis of the data.
Placebo
Used
Assignment
Parallel
Other design features

Secondary Ids

empty

Ethics committees

1

Ethics committee
Name of ethics committee
Ethics committee of Alborz University of Medical Sciences
Street address
Alborz University of Medical Sciences, administrative city, north Taleghani avenue, Karaj, Alborz
City
Alborz
Province
Alborz
Postal code
3149779453
Approval date
2018-03-10, 1396/12/19
Ethics committee reference number
Abzums.Rec.1396.162

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
LDL
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
HDL
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
Triglyceride
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
Insulin
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
HbA1c
Timepoint
Before the start of the trial and 10 weeks after taking the drug or placebo
Method of measurement
Standards of medical diagnostic laboratories

6

Description
Blood pressure
Timepoint
Before the start of the trial and 10 weeks after taking the drug or placebo
Method of measurement
Standards of medical diagnostic laboratories

7

Description
Total Protein
Timepoint
Before the start of the trial and 10 weeks after taking the drug or placebo
Method of measurement
Standards of medical diagnostic laboratories

8

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

9

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

10

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

11

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

12

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

13

Description
DHEA-SO4
Timepoint
Before the start of the trial and 10 weeks after taking the drug or placebo
Method of measurement
Standards of medical diagnostic laboratories

14

Description
TSH
Timepoint
Before the start of the trial and 10 weeks after taking the drug or placebo
Method of measurement
Standards of medical diagnostic laboratories

15

Description
Urinalysis and culture
Timepoint
Before the start of the trial and 10 weeks after taking the drug or placebo
Method of measurement
Standards of medical diagnostic laboratories

16

Description
heart beat
Timepoint
Before the start of the trial and 10 weeks after taking the drug or placebo
Method of measurement
Standards of medical diagnostic laboratories

17

Description
Vitamin D3
Timepoint
Before the start of the trial and 10 weeks after taking the drug or placebo
Method of measurement
Standards of medical diagnostic laboratories

18

Description
Pap smear
Timepoint
Before the start of the trial
Method of measurement
Standards of medical diagnostic laboratories

19

Description
Prolactin
Timepoint
Before the start of the trial and 10 weeks after taking the drug or placebo
Method of measurement
Standards of medical diagnostic laboratories

20

Description
Vaginal culture
Timepoint
Before the start of the trial and 10 weeks after taking the drug or placebo
Method of measurement
Standards of medical diagnostic laboratories

21

Description
Cholesterol
Timepoint
Before the start of the trial and 10 weeks after taking the drug or placebo
Method of measurement
Standards of medical diagnostic laboratories

22

Description
Cortisol
Timepoint
Before the start of the trial and 10 weeks after taking the drug or placebo
Method of measurement
Standards of medical diagnostic laboratories

23

Description
FBS(Fasting blood sugar)
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, Abdominal Pain
Timepoint
End of the course after 10 weeks
Method of measurement
Standards of medical diagnostic laboratories

Intervention groups

1

Description
Intervention group: Elaeagnus angustifolia L powder, 15 g / day longer 10 weeks.
Category
Treatment - Drugs

2

Description
Control group(placebo):7.5 g isomalt and 7.5 g corn starch longer 10 weeks.
Category
Placebo

Recruitment centers

1

Recruitment center
Name of recruitment center
Kamali Clinic
Full name of responsible person
Dr. Bita Badehnoosh
Street address
Kamali clinic, after the first underpass, Shohada square toward foursquare Tleghani, Kraj
City
Karaj
Province
Alborz
Postal code
1941713713
Phone
+98 26 3226 8914
Email
b_badehnoosh@yahoo.com

Sponsors / Funding sources

1

Sponsor
Name of organization / entity
Karaj University of Medical Sciences
Full name of responsible person
Dr Mohammad Noori Sepehr, Vice chancellor for research
Street address
Vice chancellor for research, Alborz university of medical sciences, administrative city, Taleghani square, Karaj
City
Karaj
Province
Alborz
Postal code
1941713713
Phone
+98 26 3222 2020
Email
dr.noorisepehr@abzums.ac.ir
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Karaj University of Medical Sciences
Proportion provided by this source
45
Public or private sector
Public
Domestic or foreign origin
Domestic
Category of foreign source of funding
empty
Country of origin
Type of organization providing the funding
Academic

2

Sponsor
Name of organization / entity
Damghan university
Full name of responsible person
Dr Gholamhossein Grivani ,Vice chancellor for research
Street address
Vice chancellor for research,Damghan university, University square, Damghan city.
City
Damghan
Province
Semnan
Postal code
۴۱۱۶۷ - ۳۶۷۱۶
Phone
+98 23 3522 0081
Email
grivani@du.ac.ir
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Damghan university
Proportion provided by this source
55
Public or private sector
Public
Domestic or foreign origin
Domestic
Category of foreign source of funding
empty
Country of origin
Type of organization providing the funding
Academic

Person responsible for general inquiries

Contact
Name of organization / entity
University of Damghan
Full name of responsible person
Farzaneh Emami Nia
Position
Masters student
Latest degree
Bachelor
Other areas of specialty/work
Biochemistry
Street address
College of Biology, University of Damghan, Damghan
City
Damghan
Province
Semnan
Postal code
۴۱۱۶۷ - ۳۶۷۱۶
Phone
+98 22001395
Email
Farzaneh.Emaminia@gmail.com

Person responsible for scientific inquiries

Contact
Name of organization / entity
Damghan university/Alborz University of Medical Sciences
Full name of responsible person
Dr.Arezoo Rezaei/Dr.Bita Badehnoosh
Position
Damghan University faculty/ Alborz Medical Science faculty
Latest degree
Ph.D.
Other areas of specialty/work
Biochemistry
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
Province
Semnan
Postal code
3149779453
Phone
+98 912 332 5792
Email
arezaei@du.ac.ir

Person responsible for updating data

Contact
Name of organization / entity
Damghan University
Full name of responsible person
Arezou Rezaei
Position
Biochemistry Phd
Latest degree
Ph.D.
Other areas of specialty/work
Biochemistry
Street address
University Square, Damghan city
City
Damghan
Province
Semnan
Postal code
۴۱۱۶۷ - ۳۶۷۱۶
Phone
+98 23 3522 0081
Fax
+98 23 3522 0223
Email
arezaei@du.ac.ir

Sharing plan

Deidentified Individual Participant Data Set (IPD)
No - There is not a plan to make this available
Justification/reason for indecision/not sharing IPD
We will not disclose the private information of the participants in the project.
Study Protocol
Yes - There is a plan to make this available
Statistical Analysis Plan
Yes - There is a plan to make this available
Informed Consent Form
Undecided - It is not yet known if there will be a plan to make this available
Clinical Study Report
Yes - There is a plan to make this available
Analytic Code
Undecided - It is not yet known if there will be a plan to make this available
Data Dictionary
Undecided - It is not yet known if there will be a plan to make this available
Title and more details about the data/document
All information for study variables will be published (Estradiol, Progesterone, Testosterone, FSH and LH, TSH, Prolactin, Cortisol, DHEA-SO4, Insulin, FBS, Hemoglobin A1c, Total protein, Vitamin D, Pap smear, Urine analysis and culture, Blood pressure and Heart rate, LDL, HDL, Triglyceride, Cholesterol and Vaginal culture) in valid scientific papers.
When the data will become available and for how long
The start of the access period will be 6 months after the publication of the results.
To whom data/document is available
Results are unknown yet.
Under which criteria data/document could be used
After publishing the information in the articles, the data will be available to other researchers as well.
From where data/document is obtainable
Mobile phone Dr. Arezou Rezaei: +98 912 332 5792 E-mail address Dr. Arezou Rezaei: arezaei@du.ac.ir
What processes are involved for a request to access data/document
Once the research, analysis and publication period have been completed, email is available to researcher (arezaei@du.ac.ir) .
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