Atrophic Vaginitis
Conditions
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.
Interventions
DRUGChinese Herbal Compound Ointment
DRUGEstriol
Sponsors
First Affiliated Hospital, Sun Yat-Sen University
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
QUADRUPLE (Subject, Caregiver, Investigator, Outcomes Assessor)
Eligibility
Sex/Gender
FEMALE
Age
50 Years to 70 Years
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| symptom questionnaire scores | 77days |
| sign questionnaire scores | 77days |
Secondary
| Measure | Time frame |
|---|---|
| sIgA value of vaginae secretion | 49days |
| retreatment effective rate | Within 56days after treatment |
| recurrence rate retreatment effect | Within 28days after treatment |
| IL-1βvalue of vaginae secretion | 49days |
| PH value of vaginae secretion | 49days |
Countries
China
Contacts
Primary ContactXin Zhou, master
Backup ContactBao-guo Sun, Doctor
Outcome results
None listed