Effect and Mechanism of Jiajian Guishen Optimized Formula on Premature Ovarian Insufficiency: Insights Into m6A Modification and Oxidative Stress
试验速览
- 阶段
- 1 期
- 状态
- 尚未招募
- 发起方
- 入组人数
- 45
- 试验地点
- 1
- 主要终点
- Serum Follicle-Stimulating Hormone (FSH)
研究概览
简要总结
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
- •Inclusion Criteria for Participants with POI:
- •Meeting the Western medicine diagnostic criteria for premature ovarian insufficiency (POI);
- •Meeting the traditional Chinese medicine diagnostic criteria for the kidney deficiency and liver stagnation syndrome;
- •Aged 18-39 years;
- •Willing and able to provide written informed consent. Participants must meet all four criteria to be included.
- •Inclusion Criteria for Healthy Participants:
- •Aged 18-39 years;
- •Regular menstrual cycles;
- •Normal sex hormone and anti-Müllerian hormone (AMH) levels;
- •Willing to participate in the study and provide written informed consent.
排除标准
- •Exclusion Criteria for Participants with POI:
- •Congenital gonadal dysgenesis or a family history of premature menopause;
- •POI caused by acquired organic disease or ovarian surgery;
- •Treatment with artificial menstrual cycle therapy or other hormonal therapy within the previous three months;
- •Severe cardiovascular, cerebrovascular, hepatic, renal, hematopoietic, or psychiatric disorders;
- •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.
研究组 & 干预措施
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.
干预措施: JJGS (Drug)
Healthy control group
healthy people
结局指标
主要结局
Serum Follicle-Stimulating Hormone (FSH)
时间窗: From baseline to 3 months after treatment initiation
Blood samples are collected before and after treatment.
次要结局
- MDA(From baseline to 3 months after treatment initiation)
- Serum Luteinizing Hormone (LH)(From baseline to 3 months after treatment initiation)
- CAT(From baseline to 3 months after treatment initiation)
- FTO(From baseline to 3 months after treatment initiation)
- m6a(From baseline to 3 months after treatment initiation)
- Serum Anti-Müllerian Hormone (AMH) Level(From baseline to 3 months after treatment initiation)
- FSH/LH Ratio(From baseline to 3 months after treatment initiation)
- Serum Estradiol (E2)(From baseline to 3 months after treatment initiation)
- Traditional Chinese Medicine Syndrome Score(before and 1 month after the treatment)
- Modified Kupperman Menopausal Index (KMI)(before and 1 month after the treatment)
- Incidence of Treatment-Emergent Adverse Events(From baseline to 3 months after treatment initiation)
- HO-1(From baseline to 3 months after treatment initiation)
- NQO1(From baseline to 3 months after treatment initiation)
- SOD(From baseline to 3 months after treatment initiation)
研究者
Shi Yun
Head of Gynecology
Dongzhimen Hospital, Beijing