ITMCTR2100005476招募中4 期
Efficacy of Bushen Ningxin Decoction combined with Femoston in the treatment of heart-kidney imbalanced Premature Ovarian Insufficiency with Circadian rhythm disorder: protocol for a randomized controlled pilot trial
Jiangsu Province Hospital of Chinese Medicine, Affiliated Hospital of Nanjing University of Chinese Medicine0 个研究点开始时间: 待定最近更新:
适应症
试验速览
- 阶段
- 4 期
- 状态
- 招募中
- 发起方
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
- 性别
- Female
入选标准
- •(1) Chinese women aged from 20 to 40 years old.
- •(2) Confirmed diagnosis of POI according to the 2017 Chinese expert consensus on POI diagnosis and treatment:
- •(a) women under 40 years of age;
- •(b) irregular menstruation cycles (sporadic menstruation or menopause for at least 4 months);
- •(c) serum basal FSH level of 25 to 40 IU/L at least twice (4 weeks interval);
- •(d) karyotype normal: 46, XX.
- •(3) In line with the diagnosis criteria of TCM syndrome differentiation: heart-kidney imbalance.
- •(4) It meets the diagnostic criteria of ICSD-3 for circadian dysrhythmia sleep and wake disorder: Chronic recurrent sleep and wake disorders are mainly caused by changes in endogenous circadian timing system, or the disharmony between endogenous circadian rhythm and expected sleep and wake time, or with individual environment, society, and working time.
- •(5) No history of using hormone drugs or drugs that affect glucose metabolism within the 3 months prior to treatment.
- •(6) Volunteer to participate in this trial and give informed consent.
排除标准
- •(1) POI caused by bilateral ovariectomy, primary amenorrhea in puberty, combined with organic disease of uterus or ovary, reproductive system or breast malignant tumor;
- •(2) Sparse menstruation or amenorrhea is caused by endocrine diseases such as polycystic ovary syndrome, adrenal cortical hyperplasia, hyperprolactinemia and Sheehan syndrome;
- •(3) Patients with premenstrual POI;
- •(4) Congenital abnormal development of reproductive organs;
- •(5) Patients with serious primary diseases such as liver and kidney system, cardiovascular system or hematopoietic system;
- •(6) People with mental diseases;
- •(7) Contraindications or allergies of hormone drugs;
- •(8) Patients with other medical, neurological or mental diseases: thyroid dysfunction, dementia, Parkinson's syndrome, schizophrenia and other sleep disorders.
研究者
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