A Clinical Study on Kangfu Anti-inflammatory Suppository... | NCT04035785

Status Module

Name	Class
Xiyuan Hospital of China Academy of Chinese Medical Sciences	OTHER
Peking University First Hospital	OTHER
Beijing Obstetrics and Gynecology Hospital	OTHER

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
Kangfu anti-inflammatory suppository	Experimental	Kangfu Xiaoyan Suppository was used for 21 days, while levofloxacin + metronidazole for 10 days, levofloxacin + metronidazole for 4 days. One of the levofloxacin quinolones has broad-spectrum antimicrobial activity and strong antimicrobial activity. Metronidazole is mainly used to treat or prevent systemic or local infections caused by the above-mentioned anaerobes, such as anaerobic infections in abdominal cavity, digestive tract, female reproductive system, lower respiratory tract, skin and soft tissue, bone and joint, etc.	Drug: Kangfu Anti-inflammatory Suppository
antibiotics alone group	Placebo Comparator	One of the levofloxacin quinolones has broad-spectrum 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 gram-negative bacteria. Bacterial activity. Metronidazole is mainly used to treat or prevent systemic or local infections caused by the above-mentioned anaerobes, such as anaerobic infections in abdominal cavity, digestive tract, female reproductive system, lower respiratory tract, skin and soft tissue, bone and joint, etc.	Drug: Kangfu Anti-inflammatory Suppository

Interventions

Name	Type	Description	Arm Group Labels	Other Names
Kangfu Anti-inflammatory Suppository	Drug	To evaluate the short-term and long-term efficacy of traditional Chinese medicine of Kangfu anti-inflammatory suppository in reducing the use of antibiotics,reducing the risk of clinical use of drugs.

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
The MCCormack scale scores of 240 subjects will be assessed	assessment of the 70% reduction rate after treatment	Change from base line on the 56 days after discontinuation

Secondary Outcomes

Measure	Description	Time Frame
The neutrophils of 240 participants will be assessed	assessment of neutrophils returning to normal reference range	Change from base line on the 28 days of medication and 56 days after discontinuation
The whole blood reduced viscosity from hemorheological tests of 240 participants will be assessed

Other Outcomes

Measure	Description	Time Frame
Adverse events	Observe the incidence of adverse events after medication	Change from base line on the 28 days of medication and 56 days after discontinuation
Change of liver function	To observe whether ALT and AST are within the normal reference range after medication

Eligibility Module

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)McCormack:4-12;
(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

Name	Role	Phone	Extension	Email
Yanming Xie, BA	Contact	86-13911112416		ktzu2018@163.com
Kun Ma, Doctor	Contact	86-13521781839		wlxing@126.com

ID	Term
D034161	Pelvic Infection
D007239	Infections
D000291	Adnexal Diseases
D005831	Genital Diseases, Female
D052776	Female Urogenital Diseases
D005261	Female Urogenital Diseases and Pregnancy Complications
D000091642	Urogenital Diseases
D000091662	Genital Diseases