The Efficacy and Safety of Chinese Herbal Compound TJAOA101 in the Treatment of POI: A Multicenter, Prospective and Before-after Study.
试验速览
- 阶段
- 早期 1 期
- 状态
- 尚未招募
- 入组人数
- 100
- 试验地点
- 1
- 主要终点
- recovery rate of ovarian function
研究概览
简要总结
Premature ovarian insufficiency (POI) seriously affects the physical and mental health of women. Nowadays, Chinese herbs have huge appeal and potential in treating POI. We have created a new Chinese herbal combination TJAOA101, 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 TJAOA101 in therapy of POI. We aim to provide a solid evidence for TCM in therapy of POI.
详细描述
Premature ovarian insufficiency (POI) seriously affects the physical and mental health of women. Nowadays, Chinese herbs have huge appeal and potential in treating POI. We have created a new Chinese herbal combination TJAOA101, whereas its safety and efficacy still need to be validated in multi-center and prospective clinical trials. We are conducting a prospective and before-after clinic trial with 100 eligible women aged 18-40 diagnosed POI will be participated. All participants will be administrated TJAOA101 drug twice every day for overall 3 months. The primary outcomes will be the basal level of serum FSH. The second outcome is the recovery rate of menstruation. All the outcomes will be assessed at baseline and 1, 2, 3 months following the 3 months' treatment. Adverse events(AEs) of patients will be assessed during the follow-up. The study was approved by the Medical Ethics Committee of the Tongji Hospital, Tongji Medical College of Huazhong University of Science and Technology (TJ-IRB20220634) according to the submitted study protocol (V.2.1, 10 May 2022) and informed consent (V.2.1, 10 May 2022). The results will be presented at domestic and international conferences and published in peer reviewed journals.
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 40 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 POI is as follows: Age <40; and menopause or sporadic menstruation for more than 4 months; and bFSH>25 mIU/ml (the interval between two reexaminations should be more than one month, both reached this level)
- •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.
- •Patients had been menopause for more than 1 year.
- •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
TJAOA101
Once enrolled, participants will be administrated TJAOA101 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: TJAOA101 (Drug)
结局指标
主要结局
recovery rate of ovarian function
时间窗: 6 months
As the definition of POI is based on menstruation and bFSH, the recovery of ovarian function is also based on the recovery of these indicators. In this study, the recovery of ovarian function is defined as serum bFSH decreased more than 50%, or recover to normal level; or two consecutive periods return to normal.
次要结局
- serum AMH(6 months)