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

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

UNKNOWN

Clinical Phase

PHASE4

Total Enrollment

240 participants

Study Classification

INTERVENTIONAL

Study Start Date

2019-07-28

Study Completion Date

2020-12-31

Brief Summary

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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.

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Detailed Description

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Conditions

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Pelvic Inflammatory Diseases

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

DOUBLE

Participants Investigators

Study Groups

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Kangfu anti-inflammatory suppository

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.

Group Type EXPERIMENTAL

Kangfu Anti-inflammatory Suppository

Intervention Type 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.

antibiotics alone group

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.

Group Type PLACEBO_COMPARATOR

Kangfu Anti-inflammatory Suppository

Intervention Type 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.

Interventions

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Kangfu Anti-inflammatory Suppository

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.

Intervention Type DRUG

Eligibility Criteria

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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%;

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.

* (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

Minimum Eligible Age

20 Years

Maximum Eligible Age

50 Years

Eligible Sex

FEMALE

Accepts Healthy Volunteers

No