The Treatment Effect of Chinese Herbal Compound Ointment on Atrophic Vaginitis

Study Overview
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Brief Summary
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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
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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.

Conditions
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Atrophic Vaginitis

Intervention / Treatment
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* Drug: Chinese Herbal Compound Ointment
* Drug: Estriol


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 50 Years
Maximum Age: 70 Years

Sexes Eligible for Study
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Female

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Chinese Herbal Compound Ointment<br>This kind of CHCO composed of several chinese herbs,dong quai,angelica,resina draconis and lithospermum.The dosage of medicine for single treatment once a day in two group is 0.5g,The total time for therapy is 3 weeks. | Drug: Chinese Herbal Compound Ointment<br> <br> |
| Active Comparator: Estriol<br>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. | Drug: Estriol<br> <br> |

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| symptom questionnaire scores |  | 77days | 
| sign questionnaire scores |  | 77days | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| recurrence rate retreatment effect |  | Within 28days after treatment | 
| retreatment effective rate |  | Within 56days after treatment | 
| PH value of vaginae secretion |  | 49days | 
| sIgA value of vaginae secretion |  | 49days | 
| IL-1βvalue of vaginae secretion |  | 49days |