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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.
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Chinese Herbal Compound Ointment | Experimental | 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. |
|
| Estriol | Active Comparator | 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. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Chinese Herbal Compound Ointment | Drug |
| ||
| Estriol |
| Measure | Description | Time Frame |
|---|---|---|
| symptom questionnaire scores | 77days | |
| sign questionnaire scores | 77days |
| Measure | Description | Time Frame |
|---|---|---|
| recurrence rate retreatment effect | Within 28days after treatment | |
| retreatment effective rate | Within 56days after treatment | |
| PH value of vaginae secretion |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Xin Zhou, master | Contact | 13533259616 | myeva520@163.com | |
| Bao-guo Sun, Doctor | Contact | 13316134352 | Sunbaoguo666@126.com |
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| The First Affiliated Hospital of Sun-yat Sen University | Recruiting | Guangzhou | Guangdong | 510000 | China |
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| ID | Term |
|---|---|
| D059268 | Atrophic Vaginitis |
| ID | Term |
|---|---|
| D014627 | Vaginitis |
| D014623 | Vaginal Diseases |
| D005831 | Genital Diseases, Female |
| D052776 | Female Urogenital Diseases |
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| ID | Term |
|---|---|
| D004964 | Estriol |
| ID | Term |
|---|---|
| D004963 | Estrenes |
| D004962 | Estranes |
| D013256 | Steroids |
| D000072473 | Fused-Ring Compounds |
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| Drug |
|
| 49days |
| sIgA value of vaginae secretion | 49days |
| IL-1βvalue of vaginae secretion | 49days |
| D005261 |
| Female Urogenital Diseases and Pregnancy Complications |
| D000091642 | Urogenital Diseases |
| D000091662 | Genital Diseases |
| D011083 |
| Polycyclic Compounds |
| D045166 | Estradiol Congeners |
| D012739 | Gonadal Steroid Hormones |
| D042341 | Gonadal Hormones |
| D006728 | Hormones |
| D006730 | Hormones, Hormone Substitutes, and Hormone Antagonists |