ITMCTR2200006561尚未招募4 期
A multicenter, randomized, double-blind, placebo-controlled post marketing clinical trial to evaluate the efficacy and safety of Dong'e Ejiao in the treatment of early-onset ovarian insufficiency (blood deficiency syndrome)
试验速览
- 阶段
- 4 期
- 状态
- 尚未招募
研究概览
简要总结
暂无简介。
研究设计
- 研究类型
- Interventional study
入排标准
- 年龄范围
- 18 至 —（—）
- 性别
- Male
入选标准
- •(1) Consistent with the diagnosis of early-onset ovarian insufficiency;
- •(2) In accordance with the syndrome differentiation of blood deficiency;
- •(3) At baseline, serum follicle stimulating hormone (FSH): 25-40u / L;
- •(4) Voluntarily participate in this clinical trial, give informed consent and sign the informed consent form.
排除标准
- •(1) Age <18 years;
- •(2) Amenorrhea or menorrhea caused by various diseases such as congenital genital organ development abnormality, acquired genital organ organic disease and lesion of hypothalamus and pituitary;
- •(3) Other endocrine or metabolic immune system diseases affecting ovarian function, such as polycystic ovary syndrome, hyperprolactinemia, hyperandrogenemia, thyroid dysfunction, functional hypothalamic amenorrhea, ovarian resistance syndrome, etc;
- •(4) Early onset ovarian insufficiency caused by chromosome abnormality, gene mutation and iatrogenic factors (surgery, radiotherapy and chemotherapy);
- •(5) In the past 3 months, she has received hormone supplement treatment related to the disease (equivalent to estradiol > 1mg and didroxyprogesterone > 10mg);
- •(6) Have received non hormonal drugs and non drug treatments (such as acupuncture, external application, enema, etc.) that have therapeutic effects on the disease in the past 1 month;
- •(7) ALT or AST = 1.5 times the upper limit of normal reference value or SCR > the upper limit of normal reference value;
- •(8) Mental retardation or psychosis or neurosis;
- •(9) Complicated with serious primary diseases such as heart, brain, lung, liver, kidney, endocrine, nervous system and hematopoietic system;
- •(10) Combined with BI-RADS grade > 3 and uterine leiomyoma > 3cm;
- •(11) There are symptoms of nausea, abdominal distension, loose stools, yellow and greasy tongue coating;
- •(12) There are contraindications to periodic treatment with fenmutone hormone, known or suspected history of breast cancer, known or suspected estrogen dependent tumor (such as endometrial cancer), unexplained genital bleeding, untreated endometrial hyperplasia, previous idiopathic or existing venous thromboembolism (deep venous embolism, pulmonary embolism), active or recent arterial thromboembolic disease (such as angina pectoris, myocardial infarction), history of meningioma Acute liver disease or history of liver disease, failure to restore normal liver function indicators, known hypersensitivity to active components of fenbutone or any excipients, porphyria;
- •(13) Pregnant and lactating women or within half a year have family planning;
- •(14) Suspected or actual history of alcohol and drug abuse;
- •(15) Known or suspected history of allergy to the ingredients and excipients of the test drug;
- •(16) Participated in other clinical trials in the past 3 months;
- •(17) The investigator considers it inappropriate to participate in this clinical trial.
研究者
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