Clinical trial NCT02733731: The Treatment Effect of Chinese Herbal Compound Ointment on Atrophic Vaginitis
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: PHASE1
Conditions: Atrophic Vaginitis
Lead sponsor: First Affiliated Hospital, Sun Yat-Sen University
Sponsor class: OTHER
First posted: 2016-04-11
Enrollment: 80
Sex: FEMALE
Minimum age (years): 50
Maximum age (years): 70
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: 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.

Detailed description: 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.

Eligibility criteria: Inclusion Criteria:

* Postmenopausal women
* With typical clinical manifestations: virginal genital itching or burning sense, Increased vaginal secretions, a yellow, a serious bloody pus-like leucorrhea, or sexual intercourse pain
* Gynecological examination: Vaginal epithelium atrophy，Vaginal folds flat or disappear， mucosal hyperemia， superficial ulceration
* Both ALT and AST are normal or less than 2 times, bilirubin is normal
* Serum creatinine level is within the normal range
* ECG is normal;

Exclusion Criteria:

* Gynecological and breast Oncology, endometrial hyperplasia(≥5mm)
* Estrogenic drugs or probiotics used in four week
* Participate in other clinical trials;Thrombotic diseases
* Abnormal vaginal bleeding without clear diagnose
* Estriol allergy
* Severe pneumonia, tuberculosis, lung abscess, myocarditis
* heart,liver or kidney failure(NYHA class III-IV,ALT to AST ratio twice more than upper limit of normal
* sexually transmitted diseases;mental disorders

Primary outcomes:
measure: symptom questionnaire scores
timeFrame: 77days
measure: sign questionnaire scores
timeFrame: 77days
Secondary outcomes:
measure: recurrence rate retreatment effect
timeFrame: Within 28days after treatment
measure: retreatment effective rate
timeFrame: Within 56days after treatment
measure: PH value of vaginae secretion
timeFrame: 49days
measure: sIgA value of vaginae secretion
timeFrame: 49days
measure: IL-1βvalue of vaginae secretion
timeFrame: 49days
Other outcomes:
Locations:
city: Guangzhou
country: China
facility: The First Affiliated Hospital of Sun-yat Sen University
state: Guangdong
Study officials:
References: