Chinese Medicine(Hu Yang Yang Kun Formula) for Primary Ovarian Insufficiency:Randomized, Double-blind, DHEA-controlled Trial
试验速览
- 阶段
- 1 期
- 状态
- 已完成
- 入组人数
- 48
- 试验地点
- 1
- 主要终点
- Anti-Mullerian hormone
研究概览
简要总结
The purpose of this research is providing valuable traditional chinese medicine theory and formula in treating Primary Ovarian insufficiency.
详细描述
Primary ovarian insufficiency is a problem that is to be solved urgently in the field of reproductive endocrine. According to the basic theory of traditional Chinese Medicine and clinical experience, investigators developed a Chinese medicine formula(Hu yang yang kun,Hyyk). This research is designed according to the principle of randomized double blind control and evaluated the effectiveness and safety of Hyyk, hope to provide a kind of effective medicine in treating primary ovarian insufficiency.
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 40 Years（Adult）
- 性别
- Female
- 接受健康志愿者
- 否
入选标准
- •Menstrual cycle change more than 7 days at least 2 times,amenorrhea less than 6 months.
- •Sex hormone:bFSH>10u/L;or E2>80pg/ml.
- •AMH<1ng/ml.
- •Informed consent and truthfully answer the question.
排除标准
- •Dose not meet the inclusion criteria.
- •Genital tract malformation,congenital germinal aplasia, uterine amenorrhea and so on organic disease.
- •Endocrine diseases such Polycystic ovary syndrome、hyperprolactinemia 、dysfunctional uterine bleeding、low gonadotropin menstrual disorders and hyperthyreosis
- •Autoimmune disease patients:Hashimoto's thyroiditis,SLE,Primary chronic adrenal cortical insufficiency,Asthenic bulbar paralysis,Arthritis deformans,Idiopathic thrombocytopenic purpura, type I diabetes and so on.
- •Someone who have the following gynecological operation history: oophorocystectomy,ovarian drilling,wedgeshaped oophorectomy,adnexectomy,tubal resection,ligation of oviduct,pelvic abscess surgery,uterine arterial embolization.
- •Someone who have used reproductive toxicity drugs: tripterygium wilfordii,tripterygium hypoglaucum hutch,chemotherapeutics and so on.
- •A family history of ovarian failure.
- •Have receive hormone therapy in recent 3 months.
- •Pregnant or lactating women.
- •with serious heart,liver and kidney disease
- •With severe psychiatric disorders .
- •Have participated in other clinical trials in 3 months.
研究组 & 干预措施
Chinese Medicine intervention
Chinese medicine HuYang Yang Kun Formula 1 capsule every time per day for 3 day per month, DHEA(dehydroepiandrosterone) placebo 1 sack every time, twice a day for three months
干预措施: Chinese medicine granules (HuYang Yang Kun Formula) (Other)
Western intervention
DHEA(dehydroepiandrosterone) 1 sack every time twice a day for three months. Chinese medicine formula granules placebo 1 capsule every time per day for 3 day per month.
干预措施: dehydroepiandrosterone (Dietary Supplement)
结局指标
主要结局
Anti-Mullerian hormone
时间窗: 1year
Anti-Mullerian hormone (AMH) is a gonadal hormone synthesized by granulose cells of the ovary and Sertoli cells of the testis. Anti-Mullerian hormone is used to facilitate the evaluation of intersex disorders and as a marker in ovarian reserve assessment in the infertility cases.
次要结局
- Follicle stimulating hormone(1year)
- Menopause rating scale(1year)
- Menstrual Cycle(1year)
- Estrogen(1year)