The Efficacy and Safety of Chinese Herbal Compound Baozhu Keli in the Treatment of Ovarian Aging: A Multicenter and Prospective Study.
试验速览
- 阶段
- 早期 1 期
- 状态
- 招募中
- 入组人数
- 100
- 试验地点
- 1
- 主要终点
- the recovery rate of ovarian function
研究概览
简要总结
Ovarian aging (OA) seriously affects the physical and mental health of women. Nowadays, Chinese herbs have huge appeal and potential in treating OA. We have created a new Chinese herbal combination Baozhu Keli, whereas its safety and efficacy still need to be validated. Hence, we will perform a population-based, multicenter study to confirm the safety and efficacy of Baozhu Keli in therapy of OA. We aim to provide a solid evidence for TCM in therapy of OA.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 55 Years（Adult）
- 性别
- Female
- 接受健康志愿者
- 否
入选标准
- •The age range of patient is 18-40 years old.
- •The diagnostic criteria for ovarian aging.
- •Sign the informed consent form.
排除标准
- •Patient is known to be allergic or unsuitable for the Chinese herbal compound.
- •Women who are pregnant and lactating.
- •Abnormal uterine bleeding, except ovulation disorders.
- •Women is taking hormone drugs and has stopped taking them within 3 months;
- •Women with endometriosis, myadenosis, submucosal fibroids or the size of non- submucosal fibroids is more than 4 cm.
- •The nature of pelvic mass is unknown.
- •Women with polycystic ovary syndrome, hyperprolactinemia, hyperandrogenemia, diabetes, thyroid and adrenal dysfunction and other endocrine diseases affecting ovulation.
- •Patients with serious primary diseases such as cardiovascular, liver, kidney, lung, biliary, hematopoietic system (Hb<90g/L) and malignant tumor, and psychiatric patients.
- •Patients are participating in other clinical trials or have participated in other clinical trials within the last month.
- •Unsuitable for the study evaluated by the investigator.
研究组 & 干预措施
Treatment group
Once enrolled, participants will be administrated Baozhu Keli and followed by a 3-month medication cycle. The usage of this herbal compound is to take orally twice a day(two sacks per). Add it to about 200ml warm water and take it half an hour before breakfast in the morning and half an hour before bedtime in the evening except menstrual period.
干预措施: Baozhu Keli (Drug)
结局指标
主要结局
the recovery rate of ovarian function
时间窗: 6 months
evaluations of ovarian reserve are mainly based on the levels of AMH, basal serum FSH, and AFC. If the serum FSH level is lower than 10 mIU/mL, the serum AMH level is greater than 1.1 ng/mL,or AFC is more than 6 after treatment, it is considered effective. In addition, an improvement of more than 50% in these indicators after treatment can also be considered effective.
次要结局
未报告次要终点