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Investigating the effect of the hydro alcoholic extract of the flower of Elaeagnus angustifolia L on the sexual performance of women, a randomized clinical trial with a double-blind control

Protocol summary

Study aim
Determining the effect of hydro alcoholic extract of Elaeagnus angustifolia L. on women's sexual performance
Design
A clinical trial with a control group, with parallel groups, double-blind, randomized, phase 3 on 58 patients, a computer site is used for randomization
Settings and conduct
The location is Masoumeh Hospital, Kermanshah. After the patients are allowed to participate in the study, the subjects are randomly assigned to the intervention and treatment group, and the intervention subjects take one cc of medicine and the placebo subjects take 1 cc of placebo daily. drugs will be placed in sealed envelopes with predetermined codes by a person who is not involved in providing the treatment.
Participants/Inclusion and exclusion criteria
Married women aged 18 to 54 with a complaint of decreased sexual performance and a score of less than 28 from the sexual performance questionnaire conditions of non-entry include pregnancy and breastfeeding, oophorectomy, menopause, the use of some hormone-based drugs, or the individual's unwillingness to continue participating in the study
Intervention groups
The intervention is the hydro alcoholic extract of Elaeagnus angustifolia L. and the intervention group will consume one cc equivalent to 20 drops of the medicine daily for 30 days, and the people in the control group will also consume one cc of the placebo daily for 30 days.
Main outcome variables
The main variable of the questionnaire is the sexual function, which has 6 fields, including the fields of desire, slippery, arousal, satisfaction, orgasm, and pain. The changes in scores will be checked once overall and once in the desired areas before the intervention and once after taking the drug at the end of the study. Progesterone and estrogen hormone changes will be checked once before taking the drug and once after taking the drug

General information

Reason for update
Acronym
IRCT registration information
IRCT registration number: IRCT20230501058039N1
Registration date: 2023-05-06, 1402/02/16
Registration timing: prospective

Last update: 2023-05-06, 1402/02/16
Update count: 0
Registration date
2023-05-06, 1402/02/16
Registrant information
Name
Maryam Dezhkameh
Name of organization / entity
Country
Iran (Islamic Republic of)
Phone
+98 83 3827 0568
Email address
mdezhkameh92@gmail.com
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2023-05-31, 1402/03/10
Expected recruitment end date
2023-09-21, 1402/06/30
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Investigating the effect of the hydro alcoholic extract of the flower of Elaeagnus angustifolia L on the sexual performance of women, a randomized clinical trial with a double-blind control
Public title
Investigating the effect of the hydro alcoholic extract of the flower of Elaeagnus angustifolia L on the sexual performance of women
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria:
Married Having a constant sexual partner Healthy pelvic examination Age 18 to 54 Deficiency or loss of sexual desire caused by stress Normal and regular menstrual cycle Obtaining a score less than 28 from the sexual dysfunction questionnaire.
Exclusion criteria:
Pregnancy and breastfeeding Menopause Oophorectomy Consumption of alcohol and tobacco Wife's sexual problem Getting any disease during the study The patient's unwillingness to continue Diabetes, kidney and liver diseases, hypothyroidism, cardiovascular-cerebrovascular disease, cancer, mental disorder with drug use, use of any contraceptive and hormone-based drugs that affect libido, such as androgens, anti-androgens, SSRI , tricyclic antidepressants, progestin's and α-blockers α
Age
From 18 years old to 54 years old
Gender
Female
Phase
3
Groups that have been masked
  • Participant
  • Care provider
Sample size
Target sample size: 58
Randomization (investigator's opinion)
Randomized
Randomization description
The randomization method is block. The randomization unit is individual. The randomization tool is a statistical software, and for concealment, block randomization with 4 or 6 blocks and one-to-one allocation ratio will be used.
Blinding (investigator's opinion)
Double blinded
Blinding description
The clinician and the patient are blinded to the treatment received. Medications will be placed in sealed envelopes with predetermined codes by a person who is not involved in providing the treatment
Placebo
Used
Assignment
Parallel
Other design features

Secondary Ids

empty

Ethics committees

1

Ethics committee
Name of ethics committee
Ethics Committee of Kermanshah University of Medical Sciences
Street address
Building No, 2Shahid Beheshti Boulevard,Kermanshah
City
Kermanshah
Province
Kermanshah
Postal code
6715847141
Approval date
2023-04-11, 1402/01/22
Ethics committee reference number
IR.KUMS.REC.1402.030

Health conditions studied

1

Description of health condition studied
Decreased sexual performance in women
ICD-10 code
F52.0
ICD-10 code description
Hypoactive sexual desire disorder

Primary outcomes

1

Description
Comparison of changes in the total score and domains of the sexual function questionnaire (FSFI) after consuming the hydro alcoholic extract of Elaeagnus angustifolia L
Timepoint
The total score of the questionnaire will be checked before taking the medicine and 30 days after taking the medicine
Method of measurement
Rosen sexual function questionnaire

Secondary outcomes

1

Description
Comparison of progesterone and estrogen hormone changes
Timepoint
The amount of hormones will be measured once at the beginning of the study and once after 30 days at the end of the study
Method of measurement
Monobind kit

Intervention groups

1

Description
Intervention group: Intervention group: The drug used is the hydro alcoholic extract of Elaeagnus angustifolia L flower, which was prepared by the Soxhlet method by Eugene Sinapjoh Pharmaceutical Company. The patients will take 1 cc daily for 30 days
Category
Treatment - Drugs

Recruitment centers

1

Recruitment center
Name of recruitment center
Hazrat Masoume Hospital, Kermanshah
Full name of responsible person
Gholamreza Abdoli
Street address
Taghbestan Blvd,Kermanshah
City
Kermanshah
Province
Kermanshah
Postal code
6715938839
Phone
+98 83 3424 7006
Email
abdoli1354@gmail.com

Sponsors / Funding sources

1

Sponsor
Name of organization / entity
Kermanshah University of Medical Sciences
Full name of responsible person
Cyrus Galilee
Street address
Research and Technology Vice-Chancellor Building No, Shahid Beheshti Blvd
City
Kermanshah
Province
Kermanshah
Postal code
6714673159
Phone
+98 83 3838 4185
Email
research_it@kums.ac.ir
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Kermanshah University of Medical Sciences
Proportion provided by this source
100
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
Kermanshah University of Medical Sciences
Full name of responsible person
Gholamreza Abdoli
Position
assistant professor
Latest degree
Ph.D.
Other areas of specialty/work
Epidemiology
Street address
Isar Square, Kermanshah
City
Kermanshah
Province
Kermanshah
Postal code
6719851351
Phone
+98 83 3526 2052
Email
abdoli1354@gmail.com

Person responsible for scientific inquiries

Contact
Name of organization / entity
Kermanshah University of Medical Sciences
Full name of responsible person
Gholamreza Abdoli
Position
Assistant Professor
Latest degree
Ph.D.
Other areas of specialty/work
Epidemiology
Street address
Isar Square, Kermanshah
City
Kermanshah
Province
Kermanshah
Postal code
6719851351
Phone
+98 83 3526 2052
Email
abdoli1354@gmail.com

Person responsible for updating data

Contact
Name of organization / entity
Kermanshah University of Medical Sciences
Full name of responsible person
Gholamreza Abdoli
Position
Assistant Professor
Latest degree
Ph.D.
Other areas of specialty/work
Epidemiology
Street address
Isar Square, Kermanshah
City
Kermanshah
Province
Kermanshah
Postal code
6719851351
Phone
+98 83 3526 2052
Email
abdoli1354@gmail.com

Sharing plan

Deidentified Individual Participant Data Set (IPD)
Undecided - It is not yet known if there will be a plan to make this available
Study Protocol
Undecided - It is not yet known if there will be a plan to make this available
Statistical Analysis Plan
Undecided - It is not yet known if there will be a plan to make this available
Informed Consent Form
No - There is not a plan to make this available
Clinical Study Report
Undecided - It is not yet known if there will be 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
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