The effect of Citrus aurantium on vaginal atrophy

Phase 2

Recruiting

Conditions: Vaginal atrophy.
Postmenopausal atrophic vaginitis
N95.2

Registration Number: IRCT20200215046494N1

Lead Sponsor: Gonabad University of Medical Sciences

Brief Summary: Not available

Detailed Description: Not available

Recruitment & Eligibility

Status: Recruiting

Sex: Female

Target Recruitment: 30

Inclusion Criteria

Having amenorrhea for at least 12 months
Age 45-65 years old
Having sex with single spouse
Normal Pap smear over the past 3 years
Body mass index less than 30
Complaining of vaginal atrophy symptoms (vaginal burning, vaginal itching , Vaginal dryness and pain during intercourse)
Getting a score of = 65 on the visual analogue scale (VAS)
Having at least one symptom of vaginal mucosa descriptive evaluation table symptoms
pH value > 5
Vaginal maturation value (VMV) < 50

Exclusion Criteria

Vaginal infection or any other important genital tract disease (sexually transmitted diseases)
Excessive consumption of phytoestrogens such as soy, red clover, fenugreek and vitex during the 8 weeks prior to the study
Use of hormone replacement therapy during the 8 weeks before the study
A history of asthma and allergies to certain herbs or citrus fruits
Use of vaginal drugs or any lubricant for at least 15 days prior to study
Smoking, alcohol or any other drug
Mammary mass
Uterine bleeding or spotting
Kidney Disorders, Kidney Failure, Hypertension, Thyroid Disorders, Liver Disorders, Heart Problems, Psychological problems and epilepsy
Use of monoamine oxidase drugs, antidepressants, Antihypertensive drugs, thyroid medication, supplements and vitamins
Prolapse of pelvic organs grade 3 or More

Study & Design

Study Type: interventional

Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Vaginal acidity. Timepoint: Before and 2 and 4 weeks after intervention. Method of measurement: pH strip.;Vaginal maturation value. Timepoint: Before and 2 and 4 weeks after intervention. Method of measurement: Vaginal smear.;Subjective symptoms of vaginal atrophy. Timepoint: Before and 2 and 4 weeks after intervention. Method of measurement: Visual Analogue Scale.;Vaginal physical examination. Timepoint: Before and 2 and 4 weeks after intervention. Method of measurement: Vaginal physical examination checklist.

Secondary Outcome Measures

Name	Time	Method
Quality of life. Timepoint: Before and 2 and 4 weeks after intervention. Method of measurement: Menopause quality of life questionnaire (MENQOL questionare).