Pelvic inflammatory disease
Conditions
Interventions
Test Group:Levofloxacin Tablets, Metronidazole Tablets, Levofloxacin Tablets Simulator, Metronidazole Tablets Simulator, Fuyanxiao Capsules
Control Group:Levofloxacin Tablets, Metronidazole Tablets, Fuyanxiao Capsule Simulator
Sponsors
Dongfang Hospital, Beijing University of Chinese Medicine
Eligibility
Sex/Gender
Female
Age
20 Years to 50 Years
Inclusion criteria
Inclusion criteria: 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; 4.4= 4 points; 6.Axillary body temperature<=38.0?; 7.The patient himself gave informed consent and signed the informed consent form.
Exclusion criteria
Exclusion criteria: 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.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Pelvic Signs McCormack Scale Score; | — |
Secondary
| Measure | Time frame |
|---|---|
| Change in blood counts of white blood cells;Changes in visual analog scores of lower abdominal pain;Traditional Chinese Medicine Syndrome Integral Change Value;The incidence of sequelae;Changes in pelvic mass and effusion;Recurrence rate of pelvic inflammatory disease;Vaginal secretion smear microscopic examination of white blood cell changes;Change in blood C-reactive protein (CRP) count; | — |
Countries
China
Contacts
Public ContactJin Zhe
Dongfang Hospital, Beijing University of Chinese Medicine
Outcome results
None listed