ITMCTR2100004358招募中1 期
A multicenter, randomized, double-blind, placebo-controlled clinical trial of kunning oral solution for the prevention of postoperative intrauterine adhesions (hysteroscopic intrauterine adhesions separation)
试验速览
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
- 性别
- Female
入选标准
- •Subjects must meet all of the following criteria to be selected:
- •(1) It meets the diagnostic criteria of western medicine for intrauterine adhesions, and it belongs to mild or moderate intrauterine adhesions;
- •(2) In line with the TCM syndrome differentiation, the diagnostic criteria of qi stagnation and blood stasis syndrome;
- •(3) Female patients >= 18 years old and <= 45 years old;
- •(4) Intrauterine adhesions occurred after intrauterine surgery, and hysteroscopic intrauterine adhesions separation was needed;
- •(5) Volunteer to participate in clinical trials and sign informed consent.
排除标准
- •Subjects meeting one or more of the following criteria will be excluded:
- •(1) Physiological amenorrhea, such as pregnancy or lactation, or less menstruation and amenorrhea caused by hyperprolactinemia, polycystic ovary syndrome, premature ovarian failure, pituitary disease or thyroid disease;
- •(2) Those who plan to become pregnant within the last 3 months;
- •(3) Patients with other endometrial diseases (such as fibroids, tuberculosis, uterine malformation, endometriosis, etc.) confirmed by hysteroscopy;
- •(4) Patients with acute and subacute genital tract inflammation;
- •(5) Complicated with other diseases, such as breast disease, thrombosis prone disease, lung disease, etc.;
- •(6) Patients with severe hypertension, cardiovascular, cerebrovascular, liver, kidney, hematopoietic system and other serious primary diseases;
- •(7) ALT and AST of liver function exceed 1.5 times of the upper limit of reference value, or SCR of kidney function exceed the upper limit of reference value;
- •(8) Patients who had undergone intrauterine adhesion separation;
- •(9) Patients with mental or neurological diseases;
- •(10) Patients with malignant tumor disease;
- •(11) Patients treated with estrogen or progesterone one month before surgery;
- •(12) People with allergic constitution, allergy or intolerance to known ingredients or any excipients of the drug studied;
- •(13) Suspecting or having a history of alcohol and drug abuse;
- •(14) Participating in or currently participating in other clinical trials within the last 3 months;
- •(15) The researchers consider it inappropriate to conduct clinical trials.
研究者
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