ITMCTR2100005465尚未招募4 期
A randomized, double-blind, placebo-controlled, multicenter clinical trial of efficacy and safety of Wuji Baifeng Tablet in the treatment of early-onset ovarian insufficiency (deficiency of qi and 
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研究概览
简要总结
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研究设计
- 研究类型
- Interventional study
入排标准
- 年龄范围
- 20 至 40（—）
- 性别
- Female
入选标准
- •(1) Meet the diagnostic criteria of early onset ovarian insufficiency in Western medicine;
- •(2) Meet the TCM syndrome differentiation standards of deficiency of qi and blood and deficiency of liver and kidney;
- •(3)20 = age < 40;
- •(4) The patient shall give informed consent and sign the informed consent.
排除标准
- •(1) Patients with primary POI (no spontaneous menstruation in the past) and iatrogenic POI were clearly diagnosed; Patients with ovarian resistance syndrome, abnormal reproductive tract development, polycystic ovary syndrome, hyperprolactinemia, ovarian endometriosis, central nervous system tumors, functional hypothalamic amenorrhea, thyroid dysfunction, adrenal cortex dysfunction and other related symptoms;
- •(2) women who are pregnant or breastfeeding or have a history of abortion in the last 1 month;
- •(3) patients with serious primary diseases of heart, brain, liver, kidney, hematopoietic and immune systems, blood-borne infectious diseases and mental disorders;
- •(4) Alanine aminotransferase (ALT) and aspartate aminotransferase (AST) were more than 2 times of the upper limit of normal value, and serum creatinine (Cr) was more than the upper limit of normal value;
- •(5) Those who had received hormone supplement therapy (HRT) and/or had taken Traditional Chinese medicines such as supplementing qi and blood, regulating liver and kidney in 1 month before enrollment, and the efficacy of drugs was difficult to judge;
- •(6) with mental disorders, including anxiety disorder (HAMA=14 points), depression (HAMD=17 points), etc.;
- •(7) allergic to the drug ingredients in the known experimental drug;
- •(8) Participate in other clinical studies within 1 month prior to screening.
研究者
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