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Comparing the effect of Centella Asiatica and Conjugated estrogen vaginal cream for the treatment of vaginal atrophy in postmenopausal wome

Phase 4
Recruiting
Conditions
Vaginal Atrophy.
Registration Number
IRCT20180501039490N1
Lead Sponsor
Mashhad University of Medical Sciences
Brief Summary

Not available

Detailed Description

Not available

Recruitment & Eligibility

Status
Recruiting
Sex
Female
Target Recruitment
64
Inclusion Criteria

Being Iranian and residence of Mashhad,Iran
Married and Sexually active women
age range of 40–65 years
Having reading and writing skills
Having amenorrhea for at least 12 months , or 6 months amenorrhea with FSH>40 or an endometrial thickness of 5 mm or less as determined by transvaginal ultrasonography
Getting a score of = 65 on the visual analogue scale (VAS) and having at least one symptom of physical examination scale and a vaginal pH value > 5 and Vaginal maturation index(VMV) < 50

Exclusion Criteria

Current or suspected endometrial cancer
Suspected genital cancer
Reproductive system abnormalities
Genital bleeding with unknown causes
Use of anti hypertensive drugs
Smoking or passing at least 3 months after smoking ceasation
Vaginal infections
Use of hormone replacement therapy 8 weeks before the study
Use of foods containing 40 to 60 grams (about one tbsp) of phyto estrogen (such as red clover, flaxseeds and soy beans) in the past month
Having conditions such as diabetes, chronic renal disease, arthritis, cardiovascular diseases, and active disease in the liver or gallbladder

Study & Design

Study Type
interventional
Study Design
Not specified
Primary Outcome Measures
NameTimeMethod
Vaginal pH. Timepoint: Beforeas well as 4 and 8 weeks after starting the intervention. Method of measurement: Merk PH-indicator strips.;Vaginal maturation value (VMV). Timepoint: Beforeas well as 4 and 8 weeks after starting the intervention. Method of measurement: Pathological examination.;Vaginal maturation index (VMI). Timepoint: Beforeas well as 4 and 8 weeks after starting the intervention. Method of measurement: Pathological examination.
Secondary Outcome Measures
NameTimeMethod
Most bothersome symptom(MBS). Timepoint: Beforeas well as 4 and 8 weeks after starting the intervention. Method of measurement: Visual Analogue Scale.;Vaginal physical examination. Timepoint: Beforeas well as 4 and 8 weeks after starting the intervention. Method of measurement: physical examination scale.
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