Effect and Mechanism of Jiajian Guishen Optimized Formula on Premature Ovarian Insufficiency: Insights Into m6A Modification and Oxidative Stress (JJGS ; POI)
The goal of this clinical study is to evaluate the effectiveness of JiaJian GuiShen Optimized Formula (JJGS) and explore its mechanisms involving m6A modification and oxidative stress in women with premature ovarian insufficiency (POI). The main question it aims to answer is:
Does JJGS improve ovarian function in women with POI after three menstrual cycles of treatment? Twenty-five women with POI will receive JJGS, and 20 healthy women will serve as controls. Changes in FSH, E2, LH, AMH, oxidative stress markers, plasma FTO levels, whole-blood RNA m6A levels, and symptom scores will be analyzed before and after treatment.
研究概览
研究类型
注册 (估计的)
阶段
- 第一阶段早期
联系人和位置
学习联系方式
- 姓名：Yun Shi
- 电话号码：+8613717926522
- 邮箱：zhyshiyun@126.com
研究联系人备份
- 姓名：Xiyu Li
- 电话号码：+8619212951890
- 邮箱：18165120161@163.com
学习地点
-
-
-
Beijing、中国
- Dongzhimen Hospital, Beijing University of Chinese Medicine
-
接触：
- Xueting Han
- 电话号码：+861084012709
- 邮箱：dzmyyec@126.com
-
-
参与标准
资格标准
适合学习的年龄
接受健康志愿者
有资格学习的性别
描述
Inclusion Criteria:
Inclusion Criteria for Participants with POI: 1. Meeting the Western medicine diagnostic criteria for premature ovarian insufficiency (POI); 2. Meeting the traditional Chinese medicine diagnostic criteria for the kidney deficiency and liver stagnation syndrome; 3. Aged 18-39 years; 4. Willing and able to provide written informed consent. Participants must meet all four criteria to be included.
Inclusion Criteria for Healthy Participants: 1. Aged 18-39 years; 2. Regular menstrual cycles; 3. Normal sex hormone and anti-Müllerian hormone (AMH) levels; 4. Willing to participate in the study and provide written informed consent.
Exclusion Criteria:
Exclusion Criteria for Participants with POI: 1. Congenital gonadal dysgenesis or a family history of premature menopause; 2. POI caused by acquired organic disease or ovarian surgery; 3. Treatment with artificial menstrual cycle therapy or other hormonal therapy within the previous three months; 4. Severe cardiovascular, cerebrovascular, hepatic, renal, hematopoietic, or psychiatric disorders; 5. Known allergy to any component of the study medication. Participants meeting any of the above criteria will be excluded.
Exclusion Criteria for Healthy Participants: The same as criteria 1, 3, 4, and 5 above.
学习计划
研究是如何设计的？
设计细节
- 主要用途：治疗
- 分配：非随机化
- 介入模型：并行分配
- 屏蔽：无（打开标签）
武器和干预
参与者组/臂 |
干预/治疗 |
|---|---|
|
实验性的：JJGS treatment group
JJGS is a traditional Chinese medicine formula administered to patients with POI for three menstrual cycles. Blood samples will be collected before and after treatment. |
JJGS is a traditional Chinese medicine formulation. Patients with POI will receive the formula for three menstrual cycles, and blood samples will be collected before and after treatment. Participants in the healthy control group will receive no intervention, and their blood samples will be collected at enrollment. |
|
无干预：Healthy control group
healthy people |
研究衡量的是什么？
主要结果指标
结果测量 |
措施说明 |
大体时间 |
|---|---|---|
|
Serum Follicle-Stimulating Hormone (FSH)
大体时间：From baseline to 3 months after treatment initiation
|
Blood samples are collected before and after treatment. |
From baseline to 3 months after treatment initiation
|
次要结果测量
结果测量 |
措施说明 |
大体时间 |
|---|---|---|
|
Serum Anti-Müllerian Hormone (AMH) Level
大体时间：From baseline to 3 months after treatment initiation
|
Blood samples are collected before and after treatment. |
From baseline to 3 months after treatment initiation
|
|
Serum Luteinizing Hormone (LH)
大体时间：From baseline to 3 months after treatment initiation
|
Blood samples are collected before and after treatment. |
From baseline to 3 months after treatment initiation
|
|
FSH/LH Ratio
大体时间：From baseline to 3 months after treatment initiation
|
Change in FSH/LH ratio before and after treatment. |
From baseline to 3 months after treatment initiation
|
|
Serum Estradiol (E2)
大体时间：From baseline to 3 months after treatment initiation
|
Blood samples are collected before and after treatment. |
From baseline to 3 months after treatment initiation
|
|
Traditional Chinese Medicine Syndrome Score
大体时间：before and 1 month after the treatment
|
This syndrome score evaluates three primary symptoms and twelve secondary symptoms related to traditional Chinese medicine syndrome differentiation. Total scores range from 0 to 48, with higher scores indicating more severe syndrome manifestations and a worse clinical outcome. |
before and 1 month after the treatment
|
|
Modified Kupperman Menopausal Index (KMI)
大体时间：before and 1 month after the treatment
|
The modified KMI consists of 13 menopausal symptoms, each rated on a 0-3 severity scale and weighted by symptom-specific coefficients. Total scores range from 0 to 63, with higher scores indicating more severe menopausal symptoms and a worse clinical outcome. |
before and 1 month after the treatment
|
|
Incidence of Treatment-Emergent Adverse Events
大体时间：From baseline to 3 months after treatment initiation
|
The incidence of treatment-emergent adverse events during the treatment period will be assessed, including gastrointestinal symptoms and abnormalities in liver and renal function. |
From baseline to 3 months after treatment initiation
|
|
HO-1
大体时间：From baseline to 3 months after treatment initiation
|
Blood samples are collected before and after treatment. |
From baseline to 3 months after treatment initiation
|
|
NQO1
大体时间：From baseline to 3 months after treatment initiation
|
Blood samples are collected before and after treatment. |
From baseline to 3 months after treatment initiation
|
|
CAT
大体时间：From baseline to 3 months after treatment initiation
|
Blood samples are collected before and after treatment. |
From baseline to 3 months after treatment initiation
|
|
SOD
大体时间：From baseline to 3 months after treatment initiation
|
Blood samples are collected before and after treatment. |
From baseline to 3 months after treatment initiation
|
|
MDA
大体时间：From baseline to 3 months after treatment initiation
|
Blood samples are collected before and after treatment. |
From baseline to 3 months after treatment initiation
|
|
FTO
大体时间：From baseline to 3 months after treatment initiation
|
Blood samples are collected before and after treatment. |
From baseline to 3 months after treatment initiation
|
|
m6a
大体时间：From baseline to 3 months after treatment initiation
|
Blood samples are collected before and after treatment. |
From baseline to 3 months after treatment initiation
|
其他结果措施
结果测量 |
措施说明 |
大体时间 |
|---|---|---|
|
Pregnancy Rate
大体时间：From baseline to 3 months after treatment initiation
|
The proportion of participants with fertility needs who achieved pregnancy during the 3-month treatment period will be recorded as an exploratory outcome. |
From baseline to 3 months after treatment initiation
|
合作者和调查者
赞助
研究记录日期
研究主要日期
学习开始 (估计的)
初级完成 (估计的)
研究完成 (估计的)
研究注册日期
首次提交
首先提交符合 QC 标准的
首次发布 (实际的)
研究记录更新
最后更新发布 (实际的)
上次提交的符合 QC 标准的更新
最后验证
更多信息
与本研究相关的术语
其他相关的 MeSH 术语
其他研究编号
- 2025DZMEC-450-03
- 2025DZMEC-450-03 (其他标识符：Ethics Committee of Dongzhimen Hospital Affiliated to Beijing University of Chinese Medicine)
计划个人参与者数据 (IPD)
计划共享个人参与者数据 (IPD)？
药物和器械信息、研究文件
研究美国 FDA 监管的药品
研究美国 FDA 监管的设备产品
此信息直接从 clinicaltrials.gov 网站检索，没有任何更改。如果您有任何更改、删除或更新研究详细信息的请求，请联系 register@clinicaltrials.gov. clinicaltrials.gov 上实施更改，我们的网站上也会自动更新.