ITMCTR1900002745尚未招募2 期
Multi-center, randomized, double-blind, dose-exploratory, placebo-controlled, phase II clinical trial of the efficacy and safety of stagnation and granules in the treatment of abnormal uterine bleeding
Beijing Chinese Medicine Hospital affiliated to Capital Medical University0 个研究点开始时间: 待定最近更新:
适应症
试验速览
- 阶段
- 2 期
- 状态
- 尚未招募
- 发起方
研究概览
简要总结
暂无简介。
研究设计
- 研究类型
- Interventional study
入排标准
- 年龄范围
- 18 至 45（—）
- 性别
- Female
入选标准
- •The following criteria must be fully met before they can be included:
- •(1) It meets the diagnostic criteria for chronic abnormal uterine bleeding in Western medicine.
- •(2) According to FIGO's PALM-COEIN system classification method, it is judged to be abnormal uterine bleeding - ovulation disorder (O), abnormal uterine bleeding - adenomyosis (A), abnormal uterine bleeding - endometrial polyps (P) Abnormal uterine bleeding - uterine leiomyoma (L), menorrhagia caused by placement of the IUD.
- •(3) The diagnosis of bleeding pattern is more menorrhagia: more menstruation during the screening period (2 or more in the screening period, and the total score of menstrual blood loss in the 7 days is >= 100 points).
- •(4) Comply with the syndrome differentiation standard of Chinese medicine blood stasis syndrome.
- •(5) Regular menstrual cycle, menstrual cycle >= 21 days and <= 35 days.
- •(6) The menstrual period is >= 3 days and <= 7 days.
- •(7) Women aged 18 to 45 years (including 18 and 45 years old).
- •(8) Willing to use and collect the sanitary protection products (sanitary napkins) provided by the sponsor throughout the study.
- •(9) Those who voluntarily participate in the experimental study and have signed the informed consent form.
排除标准
- •The following standards must all be inconsistent to be included:
- •(1) congenital dysplasia of the reproductive system or pelvic B-ultrasound (transabdominal) suggesting that it is not suitable for clinical trials (including but not limited to submucosal fibroids or uterine fibroids >= 3 cm in diameter, endometrial polyps > 1 cm in diameter) or require surgery Or minimally invasive treatment, or suspected of having a malignant tumor of the reproductive system.
- •(2) Uterine bleeding caused by pregnancy.
- •(3) Hemoglobin (Hb) <= 80g / L.
- •(4) The combination of cardiovascular, hepatic, renal, endocrine, blood and other systemic primary diseases, the degree is serious, the researchers judged that it is not appropriate to participate in this clinical trial.
- •(5) If ALT and/or AST are greater than 1.5 times the upper limit of the normal range, and Scr is greater than the upper limit of the normal range.
- •(6) Those with abnormal blood coagulation and clinical significance.
- •(7) Take Chinese medicine with similar functions and intensive treatment within 4 weeks, and have vaginal or oral estrogen or estrogen and progesterone treatment within 12 weeks.
- •(8) Those who are using or need to use thrombin in clinical trials.
- •(9) Breastfeeding, pregnancy, and planning for pregnancy within 6 months.
- •(10) Those who are known to be allergic to the test drug composition.
- •(11) Those who are unable to cooperate with or are unwilling to cooperate with nerves, mental disorders, etc.
- •(12) Those who have a history of alcohol dependence and drug abuse.
- •(13) Those who have participated in other clinical trials within 12 weeks prior to the participation or trial.
- •(14) Others are not suitable to participate in this clinical trial according to the judgment of the investigator.
研究者
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