The Efficacy and Safety Study of Tung's Acupuncture for Improving Ovarian Function of Polycystic Ovarian Syndrome: a Randomised Controlled Trial
试验速览
- 阶段
- 2 期
- 状态
- 已完成
- 发起方
- 入组人数
- 60
- 试验地点
- 1
- 主要终点
- Change in LH/FSH Ratio From Baseline to the End of Treatment
研究概览
简要总结
This study evaluates the efficacy and safety in improving ovarian function of polycystic ovarian syndrome in adults. Half of patients will receive Tung's acupuncture therapy, while the other half will receive Diane-35(CPA/EE) as the control group.
详细描述
Both Tung's acupuncture therapy and Diane-35(CPA/EE) could improve the symptom of patients with polycystic ovarian syndrome, but until now there is no definite evidence to indicate acupuncture could play the same role in improving ovarian function. So we design this study to observe the change of follicular development, ovary size and sex hormone( testosterone, follitropin, luteinizing hormone) before and after the treatment, and evaluate the efficacy and safty of acupuncture.
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
- Triple (Participant, Investigator, Outcomes Assessor)
入排标准
- 年龄范围
- 18 Years 至 45 Years（Adult）
- 性别
- Female
- 接受健康志愿者
- 否
入选标准
- •18-45 years old;
- •to meet the diagnostic criteria for polycystic ovary syndrome;
- •no need for pregnancy in the next six months;
- •volunteering to join this research and give informed consent prior to receiving treatment.
排除标准
- •hypertensive patients with blood pressure exceed 160/100 mmHg;
- •a history of thrombosis,cerebrolvascular diseases, cancer, liver disease or liver dysfuction, hyperlipidemia, mental disorder, and severe infection;
- •having taken any pharmacological treatments affecting reproductive endocrine system;
- •having received acupuncture in the previous three months;
- •smoking more than 15 cigarettes per day;
- •having pacemakers, metal allergies or severe fear of acupuncture.
研究组 & 干预措施
Tung's acupuncture
The Tung's acupuncture group received acupuncture treatments twice per week for 12 weeks. The study took Tung's acupoints as main acupuncture points, which were Fuke, Huanchao, Tianhuang, Renhuang, as well as the traditional acupoints Guanyuan (CV4) and Zigong (EX-CA1).
干预措施: Tung's acupuncture (Other)
CPA/EE
Cyproterone acetate/ethinylestradiol (CPA/EE) was taken orally one tablet per day from the 8th day of menstrual cycle or any day for patients with amenorrhea. The pills were administered for 21 days consecutively. The patients then stopped taking the pills for seven days and, on the eighth day, continued to take the pills again for three menstrual cycles (28 day cycles).
干预措施: Cyproterone acetate/ethinylestradiol (CPA/EE) (Drug)
结局指标
主要结局
Change in LH/FSH Ratio From Baseline to the End of Treatment
时间窗: baseline and 12 weeks
the change in LH/FSH ratio, values after 12-week treatment minus the values at baseline
次要结局
- Changes in FSH From Baseline to the End of Treatment(baseline and 12 weeks)
- Changes in Polycystic Ovary Number From Baseline to the End of Treatment(baseline and 12 weeks)
- Change in LH/FSH Ratio From Baseline to the 24th Week(baseline to the 24th week)
- Changes in Body Mass Index (BMI) From Baseline to the End of Treatment(baseline and 12 weeks)
- Changes in Ovarian Volume From Baseline to the End of Treatment(baseline and 12 weeks)
- Changes in LH From Baseline to the End of Treatment(baseline and 12 weeks)
- Changes in Total Testosterone (TT) From Baseline to the End of Treatment(baseline and 12 weeks)
- Changes in the Number of Bleeding Events From Baseline to the End of Treatment(baseline and 12 weeks)