A randomized, double-blind, parallel-controlled, multi-center clinical trial of the effectiveness and safety of Fuyanxiao Capsule in the treatment of pelvic inflammatory diseases (damp-heat stasis syndrome)

Dongfang Hospital, Beijing University of Chinese Medicine0 个研究点开始时间: 待定最近更新: 2023年2月20日

适应症

试验速览

暂无简介。

•For a qualified subject, the answer to all the selection criteria must be yes.
•1.Meet the diagnostic criteria of Western medicine for pelvic inflammatory diseases;
•2.Patients who meet the TCM syndrome of damp-heat stasis;
•3.Aged 20 to 50 years, married or have a history of sexual life;
•4.45.Lower abdominal pain VAS >= 4 points;
•6.Axillary body temperature<=38.0?;
•7.The patient himself gave informed consent and signed the informed consent form.

•For a qualified subject, the answer to all exclusion criteria must be No:
•1.Combined with medical history and physical signs, auxiliary examinations include appendicitis, ectopic pregnancy, torsion of ovarian cyst pedicle, pelvic hemorrhage, rupture of ovarian cyst, gastroenteritis, sequelae of pelvic inflammatory disease, endometriosis, adenomyosis And related symptoms caused by Neisseria gonorrhoeae infection;
•2.Patients are pregnant, lactating or planning to become pregnant in the near future;
•3.Routine blood white blood cell count> 1.1 times the upper limit of normal, and blood routine neutrophil percentage> 90%;
•4.Patients are in critical condition or have surgical indications, such as complicated fallopian tube ovarian abscess, pelvic abscess, diffuse peritonitis, sepsis, etc.;
•5.Patients with serious primary diseases and mental illnesses of the heart, brain, liver, kidney, hematopoietic and immune systems;
•6.Patients have taken relevant Chinese and Western medicines for the treatment of this disease within 1 month before enrollment, and the curative effect of the medicine is difficult to judge;
•7.Patients are allergic to the drug components of the known test drugs;
•8.Alanine aminotransferase (ALT), aspartate aminotransferase (AST) greater than 1.2 times the upper limit of normal, and blood creatinine (Cr) greater than the upper limit of normal;
•9.Participate in other clinical studies within 1 month before screening.

发起方

Dongfang Hospital, Beijing University of Chinese Medicine