The effect of Phoenix Dactylifera Spathe vaginal gel on sexual function and Vaginal Atrophy in Menopausal women

Status

Active, not recruiting

Phases

Phase 3

Study type

Interventional

Source

IRCT

Registry ID

IRCT20210517051331N1

Enrollment

110

Registered

2021-06-07

Start date

2021-06-22

Completion date

Unknown

Last updated

2021-06-21

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Sexual function in menopause

Interventions

Intervention 1: 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 Facult

Eligibility

Sex/Gender

Female

Age

No minimum to 65 Years

Inclusion 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

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

Design outcomes

Primary

Measure	Time frame
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.;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.;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.;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.;Sexual Function. Timepoint: Before the study and 30 day	—

Measure

Time frame

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.;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.;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.;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.;Sexual Function. Timepoint: Before the study and 30 day

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Countries

Iran (Islamic Republic of)

Contacts

Public ContactRana Rezaei

Ahvaz University of Medical Sciences

Rana.rezaei9288@gmail.com+98 61 3624 2356

Outcome results

None listed

Source: IRCT (via WHO ICTRP) · Data processed: Feb 4, 2026