The Treatment Effect of Chinese Herbal Compound Ointment on Atrophic Vaginitis
试验速览
- 阶段
- 1 期
- 发起方
- 入组人数
- 80
- 试验地点
- 1
- 主要终点
- symptom questionnaire scores
研究概览
简要总结
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.
详细描述
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.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
入排标准
- 年龄范围
- 50 Years 至 70 Years（Adult, Older Adult）
- 性别
- Female
- 接受健康志愿者
- 否
入选标准
- •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;
排除标准
- •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
研究组 & 干预措施
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.
干预措施: Chinese Herbal Compound Ointment (Drug)
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.
干预措施: Estriol (Drug)
结局指标
主要结局
symptom questionnaire scores
时间窗: 77days
sign questionnaire scores
时间窗: 77days
次要结局
- 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)
研究者
Zhou Xin
Principal Investigator
First Affiliated Hospital, Sun Yat-Sen University