Objective:To evaluate the effect and safety of the traditional chinese medicine oil agent on senile atrophic compared as compared to estriol cream in aged woman. Design: A randomized double-blind controlled trial. Setting: The hospital ward. Participants: 200 postmenopausal woman with senile vaginitis (mean age 56). Intervention: The traditional chinese medicine oil and estriol cream were separately intravaginal administrated in treatment group and control group for 3 weeks,follow-up 1 month. Measurement: symptom improving(pain and itch) and onset time, edema-size of vaginal wall, vaginal discharge, and PH changes.
80 postmenopausal women living in the communities near the hospital with AV (atrophic vaginitis) symptoms were recruited for this clinical trial. Patients with AV receiving external treatment and requiring hospitalization were randomized in a double-blind, single-centre trial. Subjects received CHCO (Chinese Herbal Compound Ointment) topical vaginal application in experimental group, while estriol in control group. The dosage of medicine for single treatment once a day in two group is 0.5g.The total time for therapy is 3 weeks in two groups. Assessment indicators:vagine PH, sIgA and IL-1βchanges, the degree of symptoms improving, onset time, edema-size of vaginal wall, vaginal discharge, and relapses and retreatment effect.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
QUADRUPLE
Enrollment
80
The First Affiliated Hospital of Sun-yat Sen University
Guangzhou, Guangdong, China
RECRUITINGsymptom questionnaire scores
Time frame: 77days
sign questionnaire scores
Time frame: 77days
recurrence rate retreatment effect
Time frame: Within 28days after treatment
retreatment effective rate
Time frame: Within 56days after treatment
PH value of vaginae secretion
Time frame: 49days
sIgA value of vaginae secretion
Time frame: 49days
IL-1βvalue of vaginae secretion
Time frame: 49days
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