研究疾病:
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卵巢储备功能减退
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研究疾病代码:
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Target disease:
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DOR
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Target disease code:
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研究类型:
Study type:
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干预性研究
Interventional study
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研究设计:
Study design:
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随机平行对照
randomized controlled trial(parallel group design)
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研究所处阶段:
Study phase:
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上市后药物
Post-marketing clinical trial
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研究目的:
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(1) 主要目的:评价乌鸡白凤片对卵巢储备功能减退(气血不足、肝肾亏虚证)患者对FSH变化值的影响;
(2) 次要目的:评价乌鸡白凤片对卵巢储备功能减退(气血不足、肝肾亏虚证)患者中医证候、性激素水平、抗缪勒管激素(AMH)水平、窦卵泡计数、月经失血图评分、焦虑抑郁HAMA/HAMD的影响;
(3) 安全性目的:评价乌鸡白凤片对卵巢储备功能减退(气血不足、肝肾亏虚证)患者临床应用的安全性
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Objectives of Study:
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(1) Main objective: To evaluate the effect of Wuji Baifeng tablet on the change value of FSH in patients with reduced ovarian reserve function (deficiency of qi and blood, deficiency of liver and kidney);
(2) Secondary objective: To evaluate the effects of Wuji Baifeng Tablet on TCM syndrome, sex hormone level, anti-Mullerian hormone (AMH) level, sinus follicle count, menstrual blood loss map score, anxiety and depression HAMA/HAMD in patients with reduced ovarian reserve function (deficiency of qi and blood, deficiency of liver and kidney).
(3) Safety Objective: To evaluate the clinical safety of Wuji Baifeng tablet in patients with reduced ovarian reserve function (deficiency of qi and blood, deficiency of liver and kidney)
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药物成份或治疗方案详述:
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Description for medicine or protocol of treatment in detail:
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纳入标准:
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(1)符合西医卵巢储备功能减退的诊断标准;
(2)符合气血不足、肝肾亏虚证中医辨证标准;
(3)20岁≤年龄<40岁;
(4)患者本人知情同意,并签署知情同意书。
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Inclusion criteria
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(1) Meet the diagnostic criteria of western medicine for reduced ovarian reserve function;
(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.
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排除标准:
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(1) 明确诊断为POI者;有卵巢抵抗综合征、生殖道发育异常、多囊卵巢综合征、高催乳素血症、卵巢型子宫内膜异位症、中枢神经系统肿瘤、功能性下丘脑性闭经、甲状腺功能异常、肾上腺皮质功能异常等引起相关症状者;
(2) 妊娠、哺乳期妇女或近1个月有流产史;
(3)合并心、脑、肝、肾、造血及免疫等系统严重原发性疾病、血液传染性疾病及精神病患者;
(4)丙氨酸氨基转移酶(ALT)、天门冬氨酸氨基转移酶(AST)大于正常值上限2倍,血肌酐(Cr)大于正常值上限者;
(5)入组前1个月进行过激素补充治疗(HRT)和(或)服用过补益气血、调补肝肾类中药,致药物疗效难以判断者;
(6)合并精神障碍,包括焦虑症(HAMA≥14分),抑郁症(HAMD≥17分)等;
(7)对已知试验用药中药物成分过敏者;
(8)在筛选前1个月内参加其他临床研究。
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Exclusion criteria:
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(1) Patients with definite diagnosis of POI; 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.
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研究实施时间:
Study execute time:
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从From
2021-08-24
至To
2024-12-26
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征募观察对象时间:
Recruiting time:
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从From
2021-12-29
至To
2023-11-30
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