The Treatment Effect of Chinese Herbal Compound Ointment on Atrophic Vaginitis

• Status: Unknown status
• Trial end date: 2016-06-01
• Target enrollment: 0
• Participant gender: Female

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.

• Phase: Phase 1
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: First Affiliated Hospital, Sun Yat-Sen University

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