The Treatment Effect of Chinese Herbal Compound Ointment on Atrophic Vaginitis
NCT ID: NCT02733731
Last Updated: 2016-04-11
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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UNKNOWN
PHASE1
80 participants
INTERVENTIONAL
2016-02-29
2016-06-30
Brief Summary
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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.
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Detailed Description
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Conditions
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
QUADRUPLE
Study Groups
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Chinese Herbal Compound Ointment
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.
Chinese Herbal Compound Ointment
Estriol
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.
Estriol
Interventions
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Chinese Herbal Compound Ointment
Estriol
Eligibility Criteria
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Inclusion Criteria
* 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
* 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
50 Years
70 Years
FEMALE
No
Sponsors
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First Affiliated Hospital, Sun Yat-Sen University
OTHER
Responsible Party
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Zhou Xin
Principal Investigator
Locations
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The First Affiliated Hospital of Sun-yat Sen University
Guangzhou, Guangdong, China
Countries
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Central Contacts
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Facility Contacts
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Other Identifiers
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Zxin
Identifier Type: -
Identifier Source: org_study_id
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