The effect of combined vaginal gel of Quercus brantii and fennel (Foeniculum vulgare) on the sexual function and quality of sexual life of menopausal women
Investigating the effect of combined gel of oak placenta and fennel on sexual performance and quality of sexual life of postmenopausal women
Design
A clinical trial with a control group/parallel/double-blind/randomized on 80 people/simple randomization, using a table of random numbers
Settings and conduct
Refer to the selected health centers, collect the list of eligible women, voluntary participation of people in the study, fully explain the method of conducting the study to the people, divide the samples into two intervention and control groups, give tubes containing gel and placebo for 8 weeks. Observing people during this period by making phone calls and referrals, completing questionnaires before and after starting treatment and then interpreting the results. The researcher and the patient do not know about the type of prescription and it is double-blind.
Participants/Inclusion and exclusion criteria
Inclusion criteria:
One year has passed since the last menstrual period or FSH >40
Age 45-65 years
Having sex and monogamy
Non-entry criteria:
Vaginal infection
Genital abnormality
Hormone therapy 8 weeks before the study
Use of vaginal drugs 15 days before the study
Smoking
breast disease
uterine bleeding
Abundant consumption of phytoestrogen for the past month
BMI>30
Liver, kidney, thromboembolism and high blood pressure disorders
Intervention groups
\Both the intervention and control groups will be given a 50 gram tube to consume for 8 weeks. The intervention group tube contains gel and the control group tube contains placebo. Questionnaires will be completed by people before and after consumption.
Main outcome variables
Sexual performance, quality of sexual life, satisfaction with treatment
General information
Reason for update
Acronym
IRCT registration information
IRCT registration number:IRCT20240506061682N1
Registration date:2024-06-19, 1403/03/30
Registration timing:prospective
Last update:2024-06-19, 1403/03/30
Update count:0
Registration date
2024-06-19, 1403/03/30
Registrant information
Name
Sara Nikkhah
Name of organization / entity
Country
Iran (Islamic Republic of)
Phone
+98 917 841 6273
Email address
saranik358@gmail.com
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2024-07-20, 1403/04/30
Expected recruitment end date
2024-09-20, 1403/06/30
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
The effect of combined vaginal gel of Quercus brantii and fennel (Foeniculum vulgare) on the sexual function and quality of sexual life of menopausal women
Public title
Investigating the effect of combined vaginal gel of oak placenta and fennel on sexual function and quality of sexual life of postmenopausal women
Purpose
Supportive
Inclusion/Exclusion criteria
Inclusion criteria:
Passing at least one year since the last menstruation, having a hormone test with an FSH level greater than 40 international units
age range of 45-65 years
having sex and being monogamous
Exclusion criteria:
Age
From 45 years old to 65 years old
Gender
Female
Phase
3
Groups that have been masked
Participant
Care provider
Investigator
Outcome assessor
Data analyser
Data and Safety Monitoring Board
Sample size
Target sample size:
80
Randomization (investigator's opinion)
Randomized
Randomization description
First, people will be randomly assigned to two groups of herbal gel and placebo by Computer Random Generation method. The tubes will be coded by the pharmacist using a table of random numbers and noted by the pharmacist, so that each tube has a unique code. Only the pharmacist knows which tube contains gel and which tube contains placebo. Researchers or volunteers participating in the project are covered.
Blinding (investigator's opinion)
Double blinded
Blinding description
Both the menopausal women participating in the project and the researcher related to them are unaware of the exposure received, the tube and box of gel and placebo are offered in a completely similar appearance and packaging, and each has its own code, which is only the pharmacist of the mentioned items. knows
Placebo
Used
Assignment
Parallel
Other design features
Secondary Ids
empty
Ethics committees
1
Ethics committee
Name of ethics committee
Ethics Committee of Yasouj University of Medical Sciences
Street address
Qorani Blvd./ Shahid Dehrabpur St./ Corner of Jhanbazan 8
City
yasuj
Province
Kohgilouyeh-va-Boyrahmad
Postal code
7591396661
Approval date
2024-04-27, 1403/02/08
Ethics committee reference number
IR.YUMS.REC.1403.005
Health conditions studied
1
Description of health condition studied
Quality of sexual life and sexual performance
ICD-10 code
ICD-10 code description
Primary outcomes
1
Description
Questionnaire score of sexual performance
Timepoint
At the beginning of the study and before drug administration and 8 weeks after the start of treatment
Method of measurement
Postmenopausal Women's Sexual Performance Questionnaire (FSFI)
2
Description
quality of sexual life of menopausal women
Timepoint
At the beginning of the study and before drug administration and 8 weeks after the start of treatment
Method of measurement
Women's Quality of Life Questionnaire (SQOL-F)
Secondary outcomes
1
Description
sexual desire
Timepoint
At the beginning of the study before drug administration and also after treatment
Method of measurement
Questionnaire of sexual function of postmenopausal women
2
Description
orgasm
Timepoint
At the beginning of the study before drug administration and also after treatment
Method of measurement
Questionnaire of sexual function of postmenopausal women
3
Description
Stimulation
Timepoint
At the beginning of the study before drug administration and also after treatment
Method of measurement
Questionnaire of sexual function of postmenopausal women
4
Description
get wet
Timepoint
At the beginning of the study before drug administration and also after treatment
Method of measurement
Questionnaire of sexual function of postmenopausal women
5
Description
satisfaction
Timepoint
At the beginning of the study before drug administration and also after treatment
Method of measurement
Questionnaire of sexual function of postmenopausal women
6
Description
the pain
Timepoint
At the beginning of the study before drug administration and also after treatment
Method of measurement
Questionnaire of sexual function of postmenopausal women
Intervention groups
1
Description
Intervention group: Each person received a 50-gram tube containing a combined herbal gel of oak (5.2%) and fennel (5%) with an applicator to be used for 8 weeks (one gram every night for the first two weeks, and the next six weeks every other night) will be given. Then the patient will be called to the health center through a phone call. The patient will be taught the duration of use and the follow-up times, and the patients will be asked to return for re-examination and follow-up in the eighth week from the start of treatment. The phone number of the patients will be taken and the method of use and follow-up times will be reminded and it will be emphasized that they should not use any hormonal drugs with other vaginal ingredients. In case of any complications (such as allergy ) after taking the medicine, the intervention will be stopped and complications will be reported. Questionnaires of the quality of sexual life and sexual performance are completed by people before and after the intervention.
Category
Rehabilitation
2
Description
Control group: Each person will be given a 50 gram tube containing placebo with an applicator to be consumed for 8 weeks (one gram every night for the first two weeks, and every other night for the next six weeks). Then the patient will be called to the health center through a phone call. The patient will be taught the duration of use and the follow-up times, and the patients will be asked to return for re-examination and follow-up in the eighth week from the start of treatment. The phone number of the patients will be taken and the method of use and follow-up times will be reminded and it will be emphasized that they should not use any hormonal drugs with other vaginal ingredients. In case of any complications (such as allergy ) after taking the medicine, the intervention will be stopped and complications will be reported. Questionnaires of the quality of sexual life and sexual performance are completed by people before and after the intervention.