NCT06102655已完成早期 1 期
Effect and Mechanism of Jiajian Guishen Formulation on Premature Ovarian Insufficiency
Shi Yun1 个研究点 分布在 1 个国家目标入组 46 人开始时间: 2023年7月24日最近更新:
适应症
干预措施
相关药物
试验速览
- 阶段
- 早期 1 期
- 状态
- 已完成
- 发起方
- 入组人数
- 46
- 试验地点
- 1
- 主要终点
- follicle stimulating hormone,FSH
研究概览
简要总结
- Identify differential metabolites in POI patients.
- Analysis of differential metabolites and their involved mechanism pathways.
研究设计
- 研究类型
- Interventional
- 分配方式
- Non Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 39 Years（Adult）
- 性别
- Female
- 接受健康志愿者
- 是
入选标准
- •POI Inclusion Criteria:
- •Patients diagnosed by Western medicine with premature ovarian insufficiency;
- •Patients with Chinese medicine differentiation of kidney deficiency and liver depression;
- •18 ≤ patients' age ≤ 39 years;
- •Patients who do not use other drugs during treatment;
- •Patients who voluntarily participate in this study, sign an informed consent form, and agree to take the corresponding treatment plan.
- •The above five items must be met to be included in the POI patient group in this study.
- •Healthy subjects inclusion criteria:
- •18 ≤ Age≤ 39 years old;
- •menstrual regularity;
- •There is no abnormality in sex hormone and AMH examination;
- •Voluntarily participate in this research and sign the informed consent form;
- •Those who match the general information such as age, height, and weight of the patients included in POI.
排除标准
- •POI exclusion criteria:
- •Patients with congenital gonadal dysplasia or a family history similar to "early menopause";
- •POI patients with acquired organic lesions or ovarian surgery;
- •Patients who have taken Western medicine artificial cycle therapy or other endocrine therapy in the past three months;
- •Patients with serious primary diseases and mental disorders such as cardiovascular and cerebrovascular, liver, kidney and hematopoietic system;
- •Patients who are breastfeeding or pregnant;
- •Patients who are allergic to the drugs used in this study or have a history of previous allergy to traditional Chinese medicines.
- •Those who met any of the above 5 criteria were excluded from this study. Healthy subjects were excluded as (1), (3), (4), (5).
研究组 & 干预措施
treatment group（Jiajian Guishen Formulation）
Experimental
Jiajian Guishen Formulation is a traditional Chinese medicine, it will be used in POI patients for three menstrual cycles; their blood samples are collected before and after treatment.
干预措施: Jiajian Guishen Formulation (Drug)
结局指标
主要结局
follicle stimulating hormone,FSH
时间窗: On the 2~4th day of menstruation (amenorrhea patients before and after taking medication)
Blood samples are collected before and after treatment.
次要结局
- anti mullerian hormone, AMH(On the 2~4th day of menstruation (amenorrhea patients before and after taking medication))
- Evaluation of the efficacy of Traditional Chinese Medicine symptoms(before and1 month after the treatment)
- superoxide dismutase(On the 2~4th day of menstruation (amenorrhea patients before and after taking medication))
- testosterone, T(On the 2~4th day of menstruation (amenorrhea patients before and after taking medication))
- malondialdehyde(On the 2~4th day of menstruation (amenorrhea patients before and after taking medication))
- Improved Kupperman Scale Scoring(before and 1 month after the treatment)
- estradiol, E2(On the 2~4th day of menstruation (amenorrhea patients before and after taking medication))
- luteinizing hormone, LH(On the 2~4th day of menstruation (amenorrhea patients before and after taking medication))
- reduced glutathione, GSH(On the 2~4th day of menstruation (amenorrhea patients before and after taking medication))
- ceruloplasmin(On the 2~4th day of menstruation (amenorrhea patients before and after taking medication))
- copper(On the 2~4th day of menstruation (amenorrhea patients before and after taking medication))
- metabolite level(On the 2~4th day of menstruation (amenorrhea patients before and after taking medication))
- Differential metabolites and their related indexes of mechanism pathways(Differential metabolites will be tested on the 2~4th day of menstruation (amenorrhea patients before and after taking medication), related indexes of mechanism pathways will be tested after the analyses of differential metabolities)
- Number of participants with abnormal laboratory test of blood routine examination results(On the 2~4th day of menstruation (amenorrhea patients before and after taking medication))
- Number of participants with abnormal Liver and kidney function (by laboratory test results)(On the 2~4th day of menstruation (amenorrhea patients before and after taking medication))
研究者
Shi Yun
Sponsor-Investigator
Dongzhimen Hospital, Beijing
研究点 (1)
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