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The effect of Persicaria hydropiper vaginal cream based on coconut oil and sesame oil on vaginal atrophy and sexual functio

Phase 3
Conditions
F52.0
Condition 1: Vaginal atrophy in postmenopausal women. Condition 2: sexual function of postmenopausal women.
Postmenopausal atrophic vaginitis
Hypoactive sexual desire disorder
N95.2
Registration Number
IRCT20240207060932N1
Lead Sponsor
Ahvaz University of Medical Sciences
Brief Summary

Not available

Detailed Description

Not available

Recruitment & Eligibility

Status
Pending
Sex
Female
Target Recruitment
111
Inclusion Criteria

Women who have had at least one year since their last menstruation or have an FSH test of more than 40 international units
Age range 45-65 years old
Being sexually active (the participant and his wife)
The ultrasound results of the uterus and ovaries are normal
Sexual function index score less than 26.5
Having At least two signs of vaginal atrophy through objective evaluation of the vagina
Normality of the results of clinical breast examination

Exclusion Criteria

People with or suspected of endometrial and breast cancer and undergoing chemotherapy
Abnormal bleeding
vaginal infection
diabetes
cardiovascular disease
chronic kidney disease
active hepatobiliary disease
arthritis
mental illness
People under hormone therapy in the last 12 weeks
People treated with non-hormonal drugs for vaginal atrophy during the last 8 weeks
A history of unusual severe drug reactions to medicinal plants
taking blood pressure drugs
vaginal gels and lubricants
thiazide diuretics
antihistamines
antidepressants
lithium
digoxin
psychoactive drugs
danazol
benzodiazepines
barbiturates

Study & Design

Study Type
interventional
Study Design
Not specified
Primary Outcome Measures
NameTimeMethod
Subjective, objective assessment of vaginal atrophy. Timepoint: At the beginning of the research, week 8 and week 12 during treatment, 4 weeks after treatment. Method of measurement: Questionnaire for subjective and objective evaluation of vaginal atrophy and experimental investigation.;Maturation percentage of vaginal cells. Timepoint: Before intervention, after intervention. Method of measurement: Based on Meisel's formula.;Vaginal acidity. Timepoint: Before intervention, after intervention. Method of measurement: PH gauge.
Secondary Outcome Measures
NameTimeMethod
Sexual function. Timepoint: At the beginning of the research, week 8 and week 12 during treatment, 4 weeks after treatment. Method of measurement: Female Sexual Function Index-questionnaire.
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