Clinical Efficacy of Qingxin Zishen Decoction in Treating Menopausal Syndrome and Neuroendocrine Mechanism of Regulating KNDy Neurons
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 60
- 试验地点
- 1
- 主要终点
- Neuroendocrine indicators
研究概览
简要总结
The goal of this clinical trial is to determine the effects of estrogen (Fenmotong) and Qingxin Zishen Decoction on the levels of kisspeptin, NKB, and dynorphin expressed in human KNDy neurons Between patients with menopausal syndrome. The aims of the study are as follows:
- Find a new neuroendocrine mechanism of Qingxin Zishen Decoction in the treatment of menopausal syndrome.
- Evaluate the changes of new neuroendocrine indicators in the clinical treatment of menopausal syndrome.
- Develop non-hormonal drugs with definite efficacy in the treatment of menopausal syndrome.
Participants will randomly divided into the experimental group and the control group, the experimental group will be oral fenmotong, and the control group will be oral Qingxin Zi Kidney Decoction, and the efficacy, sex hormone levels and neuroendocrine index changes of the two groups will be compared.
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
- Single (Outcomes Assessor)
入排标准
- 年龄范围
- 41 Years 至 55 Years（Adult）
- 性别
- Female
- 接受健康志愿者
- 否
入选标准
- •Women aged 41~55;
- •KIM score≥ 15 points;
- •The number of hot flashes and sweating≥ 3 times/day;
- •Menopause time≥ 6 months;
- •FSH>30mIU/ml,E2<30ng/L;
- •Informed consent, voluntary testing.
排除标准
- •Unexplained vaginal bleeding;
- •Sex hormone-related malignant tumors cannot be excluded;
- •premature ovarian failure, or endometriosis, or hysterectomy, or bilateral adnexectomy;
- •Combined with primary liver and kidney dysfunction, cardiovascular and cerebrovascular diseases, blood system diseases and other serious diseases that affect their survival;
- •Exposure to sex hormone-related drugs within 3 months;
- •Patients with mental abnormalities, or those with a history of alcohol or drug abuse;
- •Those who have allergic reactions to the study drug;
- •Those who are participating in other drug clinical researchers.
研究组 & 干预措施
the experimental group
干预措施: Qingxin Zishen Decoction (Drug)
the control group
干预措施: Femoston (Drug)
结局指标
主要结局
Neuroendocrine indicators
时间窗: Baseline and 12th weeks of treatment
The patients who met the inclusion criteria were fasted before and after treatment, and the levels of hypothalamic neuronal active peptide (kisspeptin), neurokinin B (NKB) and dynorphin (Dyn) were detected by enzyme-linked immunosorbent assay (ELISA).
sex hormone
时间窗: Baseline and 12th weeks of treatment
Patients who met the inclusion criteria were collected 5 ml of cubital venous blood on an empty stomach before and after treatment, and serum estradiol (E2) and follicle-stimulating hormone (FSH) levels were detected by chemiluminescence method.
Modified Kupperman Menopausal Index
时间窗: Baseline, at the 4th, 8th and 12th weeks of treatment
The Modified Kupperman Menopausal Index is a scoring method to evaluate women's menopausal related symptoms, using the Kupperman index (KMI) score, including 13 menopausal related symptoms such as vasomotor symptoms, paresthesias, and insomnia ...Each symptom is divided into 0 to 3 points according to severity, and multiplied by different coefficients to obtain the menopausal symptom index, when the index \> 35 indicates severe symptoms, 21-35 indicates moderate symptoms, and 15-20 indicates mild symptoms.
Hot flashes and sweats on a five-level scale
时间窗: Baseline, at the 4th, 8th and 12th weeks of treatment
The symptoms of hot flashes and sweating were recorded as none, mild, moderate, severe, and very severe, and were recorded as 0, 1, 2, 3, and 4 points. Higher scores indicate more severe symptoms.
次要结局
未报告次要终点
研究者
Yun Chen
Deputy Chief Physician
Jiangsu Province Hospital of Traditional Chinese Medicine