NCT04509817Unknown不适用
Efficacy and Safety of Acupuncture on Oligomenorrhea Due to Polycystic Ovary Syndrome: an International Multicenter, Pilot Randomized Controlled Trial
适应症
试验速览
- 阶段
- 不适用
- 入组人数
- 60
- 试验地点
- 3
- 主要终点
- Change in Menstrual Frequency (cycles/month)
研究概览
简要总结
This study is an international multicenter, pilot randomized, assessor-blind, controlled trial, which is aimed to preliminarily investigate the efficacy and safety of acupuncture on oligomenorrhea due to polycystic ovary syndrome (PCOS).
详细描述
A total of 60 subjects will be recruited and randomly allocated into experimental or control group with 30 subjects respectively. The subjects in experimental group will receive a standardized acupuncture treatment plus usual care, whereas the ones in control group will be managed only with usual care.
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
- Single (Outcomes Assessor)
盲法说明
The assessor will be masked.
入排标准
- 年龄范围
- 20 Years 至 40 Years（Adult）
- 性别
- Female
- 接受健康志愿者
- 否
入选标准
- •Oligomenorrhea (menstrual cycle> 35 days or less than 8 cycles per year) plus at least one of the following two criteria; hyperandrogenism (clinical, biochemical, or both) and/or polycystic ovarian morphologic features [12 or more antral follicles (2 to 9 mm in diameter) in either ovary, an ovarian volume that is greater than 10 ml in either ovary, or both]
- •20-40 years of age
- •Voluntary agreement to participate in this trial
排除标准
- •Pregnancy, labor or breastfeeding within the past 3 months
- •Intake of oral contraceptive or ovulation inducing agent within the past 3 months
- •Severe oligomenorrhea with menstrual period over 3 months
- •Menstruation during more than 8 days
- •Premature ovarian failure
- •Resistant thyroid disease, Cushing's disease, congenital adrenal hyperplasia, or hyperprolactinemia
- •Ovarian tumor or adrenal tumor that cause hyperandrogenemia
- •Hemorrhagic disease
- •Severe cardiac, pulmonary, hepatic, or renal diseases, central nervous system disorders, or intake of psychoactive drug
- •Acupuncture treatment within the past one month
- •Participation in other clinical trial within the past 3 months
- •Other conditions judged to be inappropriate for the clinical study by the investigators
结局指标
主要结局
Change in Menstrual Frequency (cycles/month)
时间窗: Baseline, post-intervention (16 weeks), follow-up (32 weeks)
Menstrual cycle improvement will be assessed by menstrual frequency (cycle/month).
次要结局
- Change in Menstrual Period(Baseline, post-intervention (16 weeks), follow-up (32 weeks))
- Change in Free Testosterone (T)(Baseline, post-intervention (16 weeks), follow-up (32 weeks))
- Change in Estradiol (E2)(Baseline, post-intervention (16 weeks), follow-up (32 weeks))
- Change in Luteinizing Hormone (LH)(Baseline, post-intervention (16 weeks), follow-up (32 weeks))
- Change in Serum Follicle Stimulating Hormone (FSH)(Baseline, post-intervention (16 weeks), follow-up (32 weeks))
- Change in LH/FSH Ratio(Baseline, post-intervention (16 weeks), follow-up (32 weeks))
- Change in Antral Follicle Count (AFC) in the Ovary and Ovarian Volume(Baseline, post-intervention (16 weeks), follow-up (32 weeks))
- Change in Body mass index (BMI)(Baseline, post-intervention (16 weeks), follow-up (32 weeks))
- Change in quality of life evaluated by the 36-Item Short Form Health Survey (SF-36)(Baseline, post-intervention (16 weeks), follow-up (32 weeks))
- Incidence of abnormal complete blood count(Baseline, post-intervention (16 weeks), follow-up (32 weeks))
- Change in Waist Hip Ratio (WHR)(Baseline, post-intervention (16 weeks), follow-up (32 weeks))
- Change in acne severity evaluated by Pillsbury acne grading system(Baseline, post-intervention (16 weeks), follow-up (32 weeks))
- Adverse events(up to 32 weeks)
- Incidence of abnormal erythrocyte sedimentation rate(Baseline, post-intervention (16 weeks), follow-up (32 weeks))
- Incidence of abnormal renal function(Baseline, post-intervention (16 weeks), follow-up (32 weeks))
- Incidence of abnormal liver function(Baseline, post-intervention (16 weeks), follow-up (32 weeks))
研究者
Chunlan Jin
Associated professor
China Academy of Chinese Medical Sciences
研究点 (3)
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