A multicenter, randomized, double-blind, placebo-controlled clinical trial of kunning oral solution for the prevention of postoperative intrauterine adhesions (hysteroscopic intrauterine adhesions separation)
- Conditions
- Intrauterine adhesions
Recruitment & Eligibility
- Status
- Recruiting
- Sex
- Female
- Target Recruitment
- Not specified
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.
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.
Study & Design
- Study Type
- Interventional study
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method Menstruation score;Markers of endometrial receptivity;TCM syndrome scoring;Endometrial thickness under ultrasound;Endometrium and subendometrium blood flow parameters under ultrasound;Endometrial typing;Hysteroscopic evaluation of uterine cavity morphology;
- Secondary Outcome Measures
Name Time Method