A Clinical Study on Kangfu Anti-inflammatory Suppository of Gynaecology Combined With Antibiotics for Pelvic Inflammatory Diseases (Evidence of Dampness and Heat Accumulation)

Study Overview
=================
Brief Summary
-----------------
To evaluate the efficacy and safety of Kangfu Xiaoyan Suppository in the treatment of pelvic inflammatory diseases (dampness-heat accumulation syndrome) and its influence on the sequelae of pelvic inflammatory diseases, and to study the role of traditional Chinese medicine in reducing the use of antibiotics and the risk of clinical medication, taking levofloxacin + metronidazole as the control drug.

Official Title
-----------------
A Clinical Study on Kangfu Anti-inflammatory Suppository of Gynaecology Combined With Antibiotics for Pelvic Inflammatory Diseases (Evidence of Dampness and Heat Accumulation):a Randomized, Double Blind, Parallel Control of Positive Drugs,Multi-center Clinical Study

Conditions
-----------------
Pelvic Inflammatory Diseases

Intervention / Treatment
-----------------
* Drug: Kangfu Anti-inflammatory Suppository


Participation Criteria
=================
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

Ages Eligible for Study
-----------------
Minimum Age: 20 Years
Maximum Age: 50 Years

Sexes Eligible for Study
-----------------
Female

Accepts Healthy Volunteers
-----------------
No

Study Plan
=================
How is the study designed?
-----------------

Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Kangfu anti-inflammatory suppository<br>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<br>* 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.<br>|
| Placebo Comparator: antibiotics alone group<br>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<br>* 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.<br>|

What is the study measuring?
-----------------
Primary Outcome Measures

| Outcome Measure | 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 Outcome Measures

| Outcome Measure | 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 | assessment of whole blood viscosity returning to normal reference range | Change from base line on the 28 days of medication and 56 days after discontinuation | 
| The plasma viscosity from hemorheological tests of 240 participants will be assessed | assessment of the plasma viscosity returning to normal reference range | Change from base line on the 28 days of medication and 56 days after discontinuation | 
| The CRP of 240 participants will be assessed | assessment of the CRP returning to normal reference range | Change from base line on the 28 days of medication and 56 days after discontinuation | 
| The volume of liquid on B-mode of 240 subjects will be assessed | The changes of the volume of liquid on B-mode at different observation points before and after treatment will be assessed | Change from base line on the 28 days of medication and 56 days after discontinuation | 
| The white blood cells of 240 participants will be assessed | assessment of the white blood returning to normal reference range | Change from base line on the 28 days of medication and 56 days after discontinuation | 
| The TCM syndrome 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 | 
| The VAS score of 240 subjects will be assessed | assessment of the 70% reduction rate after treatment | Change from base line on the 56 days after discontinuation | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Kangfu Anti-inflammatory Suppository, efficacy and safety, recurrence rate, randomized, double blind, parallel control, multi-center clinical study