A Multi-center Clinical Study on the Efficacy and Safety of Kuntai Capsule Alone and in Combination With Hormones in the Treatment of Early-onset Hypoovarian Function
试验速览
- 阶段
- 4 期
- 状态
- 招募中
- 入组人数
- 120
- 试验地点
- 6
- 主要终点
- Follicle-stimulating hormone (FSH)
研究概览
简要总结
To evaluate the efficacy and safety of Kuntai capsule alone or combined with hormone therapy in improving ovarian function in POI patients (including subclinical stage).
详细描述
The study is expected to be conducted between 2021.08 and 2023.12.120 subjects with early-onset ovarian insufficiency will be randomly assigned to trial, control, or combination groups using a computer-generated randomization table.By comparing the data of primary efficacy indexes, secondary efficacy indexes and safety indexes before and after medication, The principal investigator will write and publish the paper.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Factorial
- 主要目的
- Treatment
- 盲法
- Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
盲法说明
blind experiment
入排标准
- 年龄范围
- 18 Years 至 39 Years（Adult）
- 性别
- Female
- 接受健康志愿者
- 否
入选标准
- •The women aged <40 years old.
- •Serum basal follicle stimulating hormone (FSH) level ≥15 IU/L at least twice inspection (two occasions >4 weeks apart). Rare menstruation or menopause for at least 4 months.
- •Individuals meeting the above criteria who voluntarily consented to study participation.
排除标准
- •Pregnant and lactating patients;
- •Patients with endometriosis, adenomyosis, endometrial lesions (submucous fibroids, endometrial polyps, etc.), hysteromyoma > 4cm or hysterectomy;
- •Patients with known or suspected breast cancer history and estrogen-dependent malignant tumor;
- •Patients with personal history of venous thromboembolism (VTE) or high risk of VTE (including body mass index > 30 kg/m2, smoking and family history of thrombosis);
- •Patients with porphyria;
- •Patients with serious primary diseases or mental illness such as cardiovascular, liver, kidney and hematopoietic system;
- •Patients who are participating in other clinical trials or have participated in other clinical trials in the past three months;
- •Patients who suspect or have a history of alcohol and drug abuse;
- •Patients who are known to be allergic to the test drugs or their components;
- •The researchers determined that patients are not suitable for this trial.
研究组 & 干预措施
POI patients who taking Kuntai capsule
Patients in this group will take Kuntai capsule orally, 4 capsules each time, 3 times a day, and take the medicine for 3 courses.
干预措施: Kuntai Capsule (Drug)
POI patients who accepting hormone therapy
The estrogen and progesterone sequential regimen was adopted. The drug was estradiol tablets/estradiol didroxyprogesterone tablets (Femoston). Red tablets (estradiol, 2mg/d) were taken in the first 14 days, and gray tablets (estradiol, 2mg/d, dydrogesterone,10 mg/d) were taken in the last 14 days. 28 days was a course of treatment, and 3 courses of treatment were taken.
干预措施: Femoston (Drug)
POI patients who taking Kuntai capsule combined with hormone therapy
Kuntai capsule was taken at the same dose as Kuntai group on the basis of hormone therapy for 3 courses.
干预措施: Kuntai Capsule (Drug)
POI patients who taking Kuntai capsule combined with hormone therapy
Kuntai capsule was taken at the same dose as Kuntai group on the basis of hormone therapy for 3 courses.
干预措施: Femoston (Drug)
Subclinical POI patients who taking Kuntai capsule
Subclinical POI patients in this group which with Kuntai capsule intervention. This group is a self-controlled experiment before and after treatment
干预措施: Kuntai Capsule (Drug)
结局指标
主要结局
Follicle-stimulating hormone (FSH)
时间窗: Baseline, 3 months, 6 months
Changes of the level of FSH before and after treatment
Kupperman Score
时间窗: Baseline, 3 months, 6 months
Changes of the Kupperman score before and after treatment，Kupperman Score ranges from 0 to 69, with the smaller the score, the better off the subject
次要结局
- Luteinizing hormone (LH)(Baseline, 3 months, 6 months)
- Antral follicle count (AFC)(Baseline, 3 months,)
- The peak systolic blood flow velocity （PSV）(Baseline, 3 months,)
- The end-diastolic blood flow velocity（EDV）(Baseline, 3 months,)
- anti-Müllerian hormone (AMH)(Baseline, 3 months,)
- Estradiol hormone (E2)(Baseline, 3 months, 6 months)
- Uterine artery resistance index（RI）(Baseline, 3 months,)
- Proportion of patients with normal menstruation(Baseline，3 months, 6 months, 9 months)
- Pregnancy situation(6 months)
研究者
Yuquan Zhang
Director of Obstetrics and Gynaecology
Affiliated Hospital of Nantong University