A Randomized, Double-Blind, Placebo-Controlled Trial Comparing Bu Shen Yi Qi Formula With Chinese Herbal Placebo Combined With Dehydroepiandrosterone (DHEA) for the Treatment of Ovarian Dysfunction
试验速览
- 阶段
- 1 期
- 状态
- 招募中
- 发起方
- 入组人数
- 74
- 试验地点
- 1
- 主要终点
- AMH
研究概览
简要总结
The purpose of this clinical trial is to evaluate the efficacy and safety of Bushen Yiqi formula combined with dehydroepiandrosterone (DHEA) in the treatment of women with diminished ovarian reserve (DOR). The study also aims to assess the safety profile of this combined therapy.
The main questions this study aims to answer include:
- Can the Bushen Yiqi formula combined with DHEA improve ovarian reserve in women with DOR?
- Does the combined treatment improve hormone levels, ovarian follicle parameters, and clinical symptoms?
- What safety issues may occur during treatment with the Bushen Yiqi formula combined with DHEA?
Researchers will compare the Bushen Yiqi formula combined with DHEA to DHEA plus placebo to determine whether the combined therapy is more effective in treating diminished ovarian reserve.
Participants will:
- Be randomly assigned to either the treatment group or the control group
- Receive DHEA combined with the Bushen Yiqi formula or DHEA combined with placebo for 12 weeks
- Undergo regular clinical assessments during the study period
- Have ovarian reserve markers (including AMH and antral follicle count), sex hormone levels (FSH, LH, E2, and testosterone), traditional Chinese medicine symptom scores, Kupperman menopausal index scores, inflammatory markers (CRP and IL-6), and safety indicators evaluated before and after treatment
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
- Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
入排标准
- 年龄范围
- 20 Years 至 40 Years（Adult）
- 性别
- Female
- 接受健康志愿者
- 是
入选标准
- •Patients who meet both the Western medical diagnostic criteria for DOR and the Traditional Chinese Medicine (TCM) diagnostic criteria.
- •Female patients aged 20-40 years (inclusive).
- •No use of estrogen or progestin medications within the past three months.
- •Voluntary participation in this study, with informed consent provided and a written informed consent form signed.
排除标准
- •Concurrent reproductive endocrine, metabolic, or immune system disorders that could affect ovarian reserve or confound the evaluation of treatment efficacy, including:Polycystic ovary syndrome(PCOS),Hyperprolactinemia (a single elevated prolactin level > 3 times the upper limit of normal),Poorly controlled thyroid disease (thyroid-stimulating hormone [TSH] outside the normal reference range),Addison's disease,Systemic lupus erythematosus (SLE),Crohn's disease,Poorly controlled diabetes mellitus, etc.
- •Diminished ovarian reserve (DOR) attributable to iatrogenic factors, including:Tumor-related treatments,Surgery,Radiotherapy/Chemotherapy,Ovarian hyperstimulation from prior in vitro fertilization (IVF) cycles
- •Any of the following untreated or severe gynecological conditions:Unexplained irregular vaginal bleeding、Adnexal mass with a single largest diameter ≥ 4 cm、Stage III-IV endometriosis or bilateral ovarian endometriomas、Uterine fibroid(s) with a single largest diameter ≥ 4 cm、Endometrial polyp(s) with a single largest diameter > 1.5 cm、Planned pelvic surgery during the trial period
- •Reduced menstrual flow (oligomenorrhea/hypomenorrhea) attributable to:Congenital uterine malformations、Uterine hypoplasia、Organic pathologies of the reproductive organs、Prior intrauterine procedures
- •Patients with severe diseases of the cardiovascular or cerebrovascular system, liver, kidney, hematopoietic system, or other major organ systems, as well as those with psychiatric disorders or intellectual disabilities.
- •Pregnancy or lactation.
- •Known allergy or hypersensitivity to any component of the investigational drugs in this study.
- •Participation in any other clinical trial within the 3 months preceding randomization.
- •Unwillingness to sign the informed consent form for this study.
研究组 & 干预措施
Therapy group
Participants in the therapy group will receive dehydroepiandrosterone (DHEA) combined with the Bushen YiQi formula. DHEA will be administered orally, and the Bushen YiQi formula will be administered according to the study protocol. The treatment duration will be 12 weeks.
干预措施: Bushen formula combined with dehydroepiandrosterone (Drug)
Control group
Participants in the control group will receive dehydroepiandrosterone (DHEA) combined with placebo. DHEA will be administered orally, and the placebo will be identical in appearance and administration schedule to the Bushen YiQi formula. The treatment duration will be 12 weeks.
干预措施: Placebo combined with dehydroepiandrosterone (Drug)
结局指标
主要结局
AMH
时间窗: Blood samples were collected on days 2-4 of the menstrual cycle at three predefined time points: (1) baseline, (2) the first menstrual cycle after treatment, and (3) the first menstrual cycle following the 3-month follow-up period.
Serum anti-Müllerian hormone (AMH) levels will be measured to assess ovarian reserve function. Changes in AMH levels from baseline to post-treatment and follow-up will be compared between the treatment group and the control group.
次要结局
未报告次要终点
研究者
Ruining Liang
chief physician
Jiangxi University of Traditional Chinese Medicine