Determining the effect of vaginal aloe vera cream on function and sexual satisfaction of postmenopausal women
Design
This clinical trial has a control group, three-blind, randomized, phase 3 on 100 patients, and randomization will be done in a simple way using Excel software and random number function.
Settings and conduct
In this study, 100 menopausal women, aged 45-65 years, will be selected from among those who refer to health care centers under the supervision of Alborz University of Medical Sciences, and will be divided into two intervention and control groups. None of the participants And the researcher and the data analyst will not know which group is the intervention and which is the control. In the intervention group, the study samples will consume aloe vera vaginal cream, and in the control group, they will consume placebo (vaginal cream without any active pharmaceutical ingredients) according to the instructions. The personal and demographic information form before the start of the study and questionnaires for women's sexual function index and sexual satisfaction questionnaire will be completed by the research samples before the start of the intervention, 4 weeks after the start of the intervention and 8 weeks after the start of the intervention.
Participants/Inclusion and exclusion criteria
- Age 45-65 years
-Experience of at least 12 months of amenorrhea
-Having a husband and having sex with him
-Having symptoms of vaginal dryness, dyspareunia and itching
Intervention groups
In the intervention group: vaginal aloe vera cream will be used every night in the first two weeks and three nights a week in the next 6 weeks and during sexual intercourse, and in the control group: placebo (vaginal cream without any active pharmaceutical ingredients) will be consumed in the same way.
Main outcome variables
sexual function; sexual satisfaction
General information
Reason for update
Acronym
IRCT registration information
IRCT registration number:IRCT20240214061006N1
Registration date:2024-02-29, 1402/12/10
Registration timing:prospective
Last update:2024-02-29, 1402/12/10
Update count:0
Registration date
2024-02-29, 1402/12/10
Registrant information
Name
neda khalaji
Name of organization / entity
Country
Iran (Islamic Republic of)
Phone
+98 26 3431 8371
Email address
nedakhalaji@sbmu.ac.ir
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2024-04-02, 1403/01/14
Expected recruitment end date
2024-09-04, 1403/06/14
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
A study on the effect of vaginal aloe vera cream on the sexual function and sexual satisfaction of Post- menopausal women
Public title
A study on the effect of vaginal aloe vera cream on the sexual function and sexual satisfaction of Post- menopausal women
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria:
Age 45-65 years
Experience of at least 12 months of amenorrhea
Natural menopause (absence of menopause following surgery, absence of premature menopause (at the age of less than 40))
Postmenopausal women who are in their first 10 years of menopause.
Having a husband and having sex with her
Lack of sexual impotence in the husband (according to the woman)
Having symptoms of vaginal dryness, dyspareunia and itching
Not taking herbal hormonal drugs containing phytoestrogens or hormonal supplements in any form
Being literate in reading and writing
Not using herbal or chemical drugs affecting sexual function
No history of hysterectomy and mastectomy
A maximum of five natural births
Not having genital infections (according to the woman)
BMI less than 30
No stressful event has occurred in the last 6 months (death or illness of close relatives, major change in living situation) in any of the couples.
According to the wife, there are no mental problems (illness under observation or treatment by a doctor) in any of the couples.
Absence of disease affecting sexual function
Exclusion criteria:
Age
From 45 years old to 65 years old
Gender
Female
Phase
3
Groups that have been masked
Participant
Investigator
Data analyser
Sample size
Target sample size:
100
Randomization (investigator's opinion)
Randomized
Randomization description
The research units will be divided into two intervention and control groups in a simple random manner using Excel software and random number function. The list of people will be determined before the start of the study and people will be placed in each of the groups in order of entry. In this way, the researcher will be unaware of the type of group of each person before starting the intervention.
Blinding (investigator's opinion)
Triple blinded
Blinding description
In this research, the researcher, the participants and the data analyst will not know which group (intervention or control) each participant is in (at the beginning of the research, the participant will be informed that he may be in any of the intervention or control groups). be controlled), so that with simple random method and random number function, it will be determined that according to the participant number (which will be assigned according to the order of entry into the research) that participant will be placed in which group A or B, but Until the end of the research, it will not be clear which group A or B is intervention or control.
Placebo
Used
Assignment
Other
Other design features
Research units will be divided into intervention and control groups. The intervention group will use aloe vera vaginal cream and the control group will use placebo for 2 months.
Secondary Ids
empty
Ethics committees
1
Ethics committee
Name of ethics committee
research ethics committess of school of pharmacy and nursing and midwifery--shahid beheshti universi
Street address
Tehran, Vali Asr St., intersection of Ayat A... Hashemi Rafsanjani Highway, in front of Shahid Rajaee Heart Hospital, Faculty of Nursing and Midwifery, Shahid Beheshti University of Medical Sciences
City
Tehran
Province
Tehran
Postal code
1996835119
Approval date
2024-02-11, 1402/11/22
Ethics committee reference number
IR.SBMU.PHARMACY.REC.1402.259
Health conditions studied
1
Description of health condition studied
sexual function
ICD-10 code
ICD-10 code description
2
Description of health condition studied
sexual satisfaction
ICD-10 code
ICD-10 code description
Primary outcomes
1
Description
Sexual function score in females sexual function index questionnaire
Timepoint
At the beginning of the study and 4 and 8 weeks after starting to use vaginal aloe vera cream
Method of measurement
females sexual function index questionnaire
2
Description
Sexual satisfaction score in Hudson's sexual satisfaction questionnaire
Timepoint
At the beginning of the study and 4 and 8 weeks after starting to use vaginal aloe vera cream
Method of measurement
Hudson's sexual satisfaction questionnaire
Secondary outcomes
empty
Intervention groups
1
Description
Intervention group: In this research, aloe vera plant will be prepared from the greenhouse around Tehran and after confirming the scientific name, at the Faculty of Pharmacy of Shahid Beheshti University of Medical Sciences and Health Services, its leaves will be separated and extracted with ethanol. It is inserted into the base of the vaginal cream and it will be prepared in the form of aloe vera vaginal cream, and it will be autoclaved after preparation. which will be consumed vaginally by the research samples for 2 weeks, every night and then for the next 6 weeks, three nights a week and during sexual intercourse, 7 grams each time with an applicator.
Category
Treatment - Drugs
2
Description
Control group: In this research, the vaginal cream placebo will be based on vaginal cream without any effective ingredients (including cetostearyl alcohol, petroleum gel, glycerin, water, mineral oil, protective and antioxidant substances, etc.) Shahid Beheshti's health care services have been prepared and after preparation, it will be autoclaved, which in terms of shape, smell, color, size and amount is completely similar to vaginal aloe vera cream, which is applied every night for 2 weeks and then three nights a week for the next 6 weeks. And during sexual intercourse, 7 grams will be taken vaginally with an applicator.
Category
Treatment - Drugs
Recruitment centers
1
Recruitment center
Name of recruitment center
Health care centers under Alborz University of Medical Sciences
Tehran, Vali Asr St., intersection of Ayat A... Hashemi Rafsanjani Highway, in front of Shahid Rajaee Heart Hospital, Faculty of Nursing and Midwifery, Shahid Beheshti University of Medical Sciences
City
Tehran
Province
Tehran
Postal code
1996835119
Phone
+98 21 8865 5367
Email
msimar@yahoo.com
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Shahid Beheshti 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
Shahid Beheshti University of Medical Sciences
Full name of responsible person
Neda Khalaji
Position
Masters student
Latest degree
Bachelor
Other areas of specialty/work
Midwifery
Street address
Gohardasht, moazen blvd, north pirozi ave, bostan19, number15
City
Karaj
Province
Alborz
Postal code
3147834579
Phone
+98 26 3431 8371
Fax
Email
khalajineda3@gmail.com
Person responsible for scientific inquiries
Contact
Name of organization / entity
Shahid Beheshti University of Medical Sciences
Full name of responsible person
dr.Masoumeh simbar
Position
Professor
Latest degree
Ph.D.
Other areas of specialty/work
Midwifery
Street address
Vali Asr St., intersection of Ayat A... Hashemi Rafsanjani Highway, in front of Shahid Rajaee Heart Hospital, Faculty of Nursing and Midwifery, Shahid Beheshti University of Medical Sciences
City
Tehran
Province
Tehran
Postal code
1996835119
Phone
+98 21 8865 5376
Email
msimar@yahoo.com
Person responsible for updating data
Contact
Name of organization / entity
Shahid Beheshti University of Medical Sciences
Full name of responsible person
Neda Khalaji
Position
Masters student
Latest degree
Bachelor
Other areas of specialty/work
Midwifery
Street address
Gohardasht, moazen blvd, north pirozi ave, bostan19, number15
City
Karaj
Province
Alborz
Postal code
3147834579
Phone
+98 26 3431 8371
Fax
Email
khalajineda3@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
Undecided - It is not yet known if there will be 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