A Clinical Study on Qianjin Capsule of Gynaecology Combined With Antibiotics for Pelvic Inflammatory Diseases (Damp-heat Stasis and Qi Deficiency Syndrome)
Pelvic Inflammatory Diseases
About this trial
This is an interventional treatment trial for Pelvic Inflammatory Diseases focused on measuring Qianjin Capsule of Gynaecology, efficacy and safety, recurrence rate, randomized, double blind, parallel control, multi-center clinical study
Eligibility Criteria
Inclusion Criteria:
- (1) Women aged 20-50;
- (2) Sexual History ;
- (3) According to the diagnostic criteria of pelvic inflammatory diseases: according to the Diagnosis and Treatment Criteria of Pelvic Inflammatory Diseases (2014), the following specifications are as follows: A. uterine tenderness, or adnexal tenderness, or cervical lifting pain; B. axillary body temperature < 38 C. blood routine white blood cell count < 1.1 times the upper limit of normal value; D. blood routine neutrophil percentage < 90%; All of the above four items are available. Exclusion Criteria:
- (4)4<McCormack<12;
- (5)TCM syndrome differentiation for damp-heat stagnation and Qi deficiency syndrome, A. lower abdominal pain; B. excessive amount of belt, yellow color, or odor; C. fatigue; D. tongue red, greasy fur, or with teeth marks, or blood stasis spots; the above four items are all available;
- (6)Those who agree to participate in this clinical trial and sign the informed consent form.
Exclusion Criteria:
- (1) Pregnant or recent (within 6 months) pregnant women, lactating women ;
- (2) To identify the pathogen as Neisseria gonorrhoeae;
- (3) Symptoms related to appendicitis, ectopic pregnancy, torsion or rupture of ovarian cyst pedicle, gastroenteritis, endometriosis, adenomyosis, trichomonal vaginitis, vulvovaginal candidiasis, bacterial vaginosis, etc.;
- (4)Those with critical condition or surgical indications, such as fallopian tube and ovary abscess, pelvic abscess, diffuse peritonitis, septicemia;
- (5)In patients with severe primary diseases such as heart, brain and hematopoietic system, ALT of liver function is higher than the upper limit of normal value, and Cr of renal function is higher than the upper limit of normal value;
- (6)One month before admission, Chinese and Western medicines were used to treat the disease, which made it difficult to judge the efficacy of drugs;
- (7)Anaphylactic constitution or persons known to be allergic to the medicines and their components used in this test ;
- (8)Researchers do not consider it appropriate to participate in this clinical trial;
- (9)Suspected or true history of alcohol and drug abuse, or other pathological changes or conditions that reduce the likelihood of enrollment or complicate enrollment, such as frequent changes in the working environment, unstable living environment, etc., are liable to lead to lost interviews, according to the judgement of researchers;
- (10)Participation in other clinical researchers within 3 months before admission;
- (11)Patients with suspected or confirmed quinolone contraindications, central or peripheral neuropathy, epilepsy, and depression
Sites / Locations
Arms of the Study
Arm 1
Arm 2
Experimental
Placebo Comparator
Qianjin Capsule of Gynaecology
Antibiotics alone group
On the basis of the antibiotic levofloxacin + metronidazole for 14 days, Gynecological Qianjin Capsule for 28 days. One of the levofloxacin quinolones has broadspectrum antimicrobial activity and strong antimicrobial activity. Metronidazole is mainly used to treat or prevent systemic or local infections caused by the abovementioned anaerobes, such as anaerobic infections in abdominal cavity, digestive tract, female reproductive system, lower respiratory tract, skin and soft tissue, bone and joint, etc.
Levofloxacin + metronidazole for 14 days, and gynecological Qianjin capsule simulator for 28 days. One of the levofloxacin quinolones has broadspectrum antimicrobial activity and strong antimicrobial activity. It has strong antimicrobial activity against most Enterobacteriaceae bacteria, such as Escherichia coli, Klebsiella, Proteus, Salmonella, Shigella and Haemophilus influenzae, Legionella pneumophila, Neisseria gonorrhoeae and other gramnegative bacteria. Bacterial activity. Metronidazole is mainly used to treat or prevent systemic or local infections caused by the abovementioned anaerobes, such as anaerobic infections in abdominal cavity, digestive tract, female reproductive system, lower respiratory tract, skin and soft tissue, bone and joint, etc.