Determining the effect of Phoenix Dactylifera Spathe vaginal gel on sexual function and vaginal atrophy in postmenopausal women
Design
A clinical trial with a control group, with parallel groups, double-blind, randomized, phase 3 on 110 patients, a computer random number table is used for randomization and through blocking of 6 and 9.
Settings and conduct
Research in health centers of Shushtar city, which is first identified by screening patients and then randomly entered into intervention and control groups. using similar and opaque packets containing drugs Which are numbered from 1 based on the allocation sequence.
Participants/Inclusion and exclusion criteria
Inclusion criteria: Existence of symptoms of vaginal atrophy; Sexual function score less than 26/55
Exclusion criteria:Use of psychiatric drugs, Fluoxetine, Vitamin E, Propranolol and other chemical or herbal medicines that affect the symptoms of menopause
Intervention groups
Individuals in the intervention group are given 5% vaginal gel of Phoenix Dactylifera Spathe plant once a day, and the control group is given a vaginal gel placebo (containing gel and preservative) that looks similar to Phoenix Dactylifera Spathe extract gel. It is given once a day for 1 month.
Main outcome variables
Sexual function; Vaginal atrophy
General information
Reason for update
Acronym
IRCT registration information
IRCT registration number:IRCT20210517051331N1
Registration date:2021-06-07, 1400/03/17
Registration timing:prospective
Last update:2021-06-07, 1400/03/17
Update count:0
Registration date
2021-06-07, 1400/03/17
Registrant information
Name
Rana Rezaei
Name of organization / entity
Country
Iran (Islamic Republic of)
Phone
+98 61 3624 2356
Email address
rezaei.r@ajums.ac.ir
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2021-06-22, 1400/04/01
Expected recruitment end date
2021-11-22, 1400/09/01
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
The effect of Phoenix Dactylifera Spathe vaginal gel on sexual function and Vaginal Atrophy in Menopausal women
Public title
The effect of Phoenix Dactylifera Spathe vaginal gel on sexual function and Vaginal Atrophy in Menopausal women
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria:
Being married
Be literate
No medical condition of the woman or her husband (according to Ms. Menopause)
Age range under 65 years
More than a year has passed since the last menstrual period
Having sex for the past month
Have sex at least once a month
Existence of symptoms of vaginal atrophy
Sexual function score less than 26/55
Exclusion criteria:
Any physical or motor disability
Training on sexual issues in the last 4 weeks
Use of psychiatric drugs, Fluoxetine, Vitamin E, Propranolol and other chemical or herbal medicines that affect menopausal symptoms
Smoking and alcohol or drug use
Age
To 65 years old
Gender
Female
Phase
3
Groups that have been masked
Participant
Care provider
Investigator
Outcome assessor
Sample size
Target sample size:
110
Randomization (investigator's opinion)
Randomized
Randomization description
The grouping of the subjects in each of the intervention and control groups (55 people in each group) is done randomly (random allocation) using a computer random number table and through blocks of 6 and 9 and by a statistician.
Blinding (investigator's opinion)
Double blinded
Blinding description
To conceal allocation, similar and opaque packets are used containing drugs Which are numbered from 1 based on the allocation sequence.
Placebo
Used
Assignment
Parallel
Other design features
Secondary Ids
empty
Ethics committees
1
Ethics committee
Name of ethics committee
Ethics Committee of Ahwaz Jundishapur University of Medical Sciences
Street address
Unit 5, Parand Apartment, Shahid Afzalan Street, Komite Sokht
City
Shoushtar
Province
Khouzestan
Postal code
6451854313
Approval date
2021-05-09, 1400/02/19
Ethics committee reference number
IR.AJUMS.REC.1400.093
Health conditions studied
1
Description of health condition studied
Sexual function in menopause; Vaginal atrophy in menopause
ICD-10 code
N95
ICD-10 code description
Menopausal and other perimenopausal disorders
Primary outcomes
1
Description
Vaginal atrophy- Maturity index of vaginal mucosa cells
Timepoint
Before the study and 30 days after taking Phoenix Dactylifera Spathe vaginal gel
Method of measurement
To examine the maturity index of vaginal mucosal cells, using a sterile cotton swab, a sample of vaginal secretions and posterior fornix is taken and spread on the slide. The slide is then fixed with a fixator and placed in envelopes on which the patient's profile is written. Then, the slides prepared from the patients are sent to the pathology laboratory of Ahvaz Jundishapur University of Medical Sciences and the samples are examined for vaginal atrophy.
2
Description
Mental symptoms of vaginal atrophy
Timepoint
Before the study and 30 days after taking Phoenix Dactylifera Spathe vaginal gel
Method of measurement
Mental symptoms of vaginal atrophy will be assessed according to a 4-point self-assessment scale of a combined score including: burning, itching, vaginal dryness and dyspareunia, so that the severity of each symptom is determined by the patient and then a score according to criterion 4 A degree (0 = absence, 1 = mild = 2 moderate and 3 = severe) was given to them by the researcher and by adding the numbers related to each of the symptoms, the combined score will be calculated.
3
Description
Vaginal PH
Timepoint
Before the study and 30 days after taking Phoenix Dactylifera Spathe vaginal gel
Method of measurement
During vaginal examination with a speculum, a paper strip of pH meter is contacted to the vaginal wall with a pair of pliers and held for one minute.
4
Description
Clinical signs of Vaginal atrophy
Timepoint
Before the study and 30 days after taking Phoenix Dactylifera Spathe vaginal gel
Method of measurement
Clinical signs of atrophy are assessed by completing a descriptive evaluation table of vaginal mucosa, and if there are at least 2 symptoms of the table (vaginal folds, color, petechiae, elasticity and vaginal dryness) vaginal atrophy is diagnosed.
5
Description
Sexual Function
Timepoint
Before the study and 30 days after taking Phoenix Dactylifera Spathe vaginal gel
Method of measurement
Using a questionnaire FSFI
Secondary outcomes
empty
Intervention groups
1
Description
Intervention group: Phoenix Dactylifera Spathe vaginal gel 5% of Phoenix Dactylifera Spathe plant once a day for one month. Phoenix Dactylifera Spathe vaginal gel is made in the Faculty of Pharmacy of Ahwaz Jundishapur University.
Category
Treatment - Drugs
2
Description
Control group: placebo vaginal gel containing gel and preservative will be used once a day for a month. Placebo vaginal gel is made in the Faculty of Pharmacy of Ahwaz Jundishapur University.
Category
Placebo
Recruitment centers
1
Recruitment center
Name of recruitment center
Health Center No. 1 of Shoushtar city
Full name of responsible person
Mohamad Ali Malek Nesa
Street address
Taleghani Street
City
Shoushtar
Province
Khouzestan
Postal code
6451811111
Phone
+98 61 3621 1111
Email
Reza.vakil92881@yahoo.com
2
Recruitment center
Name of recruitment center
Health Center No. 2 of Shoushtar city
Full name of responsible person
Forozan Ghasemian
Street address
Taleghani Street
City
Shoushtar
Province
Khouzestan
Postal code
6451822222
Phone
+98 61 3622 2222
Email
Reza.vakil92882@yahoo.com
3
Recruitment center
Name of recruitment center
Health Center No. 3 of Shoushtar city
Full name of responsible person
Saba Mohamad Ghasemi
Street address
Fakharian Square
City
Shoushtar
Province
Khouzestan
Postal code
6451833333
Phone
+98 61 3623 3333
Email
Reza.vakil92883@yahoo.com
4
Recruitment center
Name of recruitment center
Health Center No. 4 of Shoushtar city
Full name of responsible person
Behzad Azizi
Street address
Shoushtar No
City
Shoushtar
Province
Khouzestan
Postal code
6451844444
Phone
+98 61 3624 4444
Email
Reza.vakil92884@yahoo.com
5
Recruitment center
Name of recruitment center
Health Center No. 5 of Shoushtar city
Full name of responsible person
Sepide Jelodar
Street address
Maskan Mehr
City
shoushtar
Province
Khouzestan
Postal code
6451855555
Phone
+98 61 3625 5555
Email
Reza.vakil92885@yahoo.com
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Ahvaz University of Medical Sciences
Full name of responsible person
Mehdi Ahmadi Moghadam
Street address
Ahvaz Jundishapur University of Medical Sciences، Deputy of research and technology،Ahvaz, Iran
City
Ahwaz
Province
Khouzestan
Postal code
15794-61357
Phone
+98 61 3336 2414
Email
itc@ajums.ac.ir
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Ahvaz 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
Ahvaz University of Medical Sciences
Full name of responsible person
Rana Rezaei
Position
Student
Latest degree
Bachelor
Other areas of specialty/work
Midwifery
Street address
Unit 5, Parand Apartment, Shahid Adizade Street, Komite Sokht
City
Shoushtar
Province
Khouzestan
Postal code
6451854313
Phone
+98 61 3624 2356
Email
Rana.rezaei9288@gmail.com
Person responsible for scientific inquiries
Contact
Name of organization / entity
Ahvaz University of Medical Sciences
Full name of responsible person
Mina Iravani
Position
Associate professor
Latest degree
Ph.D.
Other areas of specialty/work
Midwifery
Street address
Faculty of Nursing and Midwifery - University City - Golestan Road - Ahvaz