A Clinical Study on Qianjin Capsule of Gynaecology Combined With Antibiotics for Pelvic Inflammatory Diseases (Damp-heat Stasis and Qi Deficiency Syndrome)
NCT ID: NCT04031664
Last Updated: 2019-07-31
Study Results
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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UNKNOWN
PHASE4
184 participants
INTERVENTIONAL
2019-08-02
2020-12-31
Brief Summary
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Detailed Description
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Conditions
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Keywords
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
DOUBLE
Study Groups
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Qianjin Capsule of Gynaecology
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.
Qianjin Capsule of Gynaecology
To evaluate the short-term and long-term efficacy of traditional Chinese medicine of Qianjin Capsule of Gynaecology in reducing the use of antibiotics, reducing the risk of clinical use of drugs.
Antibiotics alone group
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.
Qianjin Capsule of Gynaecology
To evaluate the short-term and long-term efficacy of traditional Chinese medicine of Qianjin Capsule of Gynaecology in reducing the use of antibiotics, reducing the risk of clinical use of drugs.
Interventions
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Qianjin Capsule of Gynaecology
To evaluate the short-term and long-term efficacy of traditional Chinese medicine of Qianjin Capsule of Gynaecology in reducing the use of antibiotics, reducing the risk of clinical use of drugs.
Eligibility Criteria
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Inclusion Criteria
* (2) Sexual History ;
Exclusion Criteria
* (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
20 Years
50 Years
FEMALE
No
Sponsors
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Xiyuan Hospital of China Academy of Chinese Medical Sciences
OTHER
Peking University First Hospital
OTHER
Beijing Obstetrics and Gynecology Hospital
OTHER
Longhua Hospital
OTHER
Third Hospital of Peking University
UNKNOWN
Peking Union Medical College Hospital
OTHER
First Affiliated Hospital of Tianjin University of Traditional Chinese Medicine
UNKNOWN
Shenzhen Maternal and Child Health Hospital
UNKNOWN
First Affiliated Hospital of Heilongjiang University of Traditional Chinese Medicine
UNKNOWN
Chengdu University of Traditional Chinese Medicine
OTHER
China Academy of Chinese Medical Sciences
OTHER
Responsible Party
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Yanming Xie
Deputy director
Principal Investigators
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Yanming Xie, BA
Role: PRINCIPAL_INVESTIGATOR
Institute of Basic Research in Clinical Medicine, China Academy of Chinese
Central Contacts
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Other Identifiers
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Qianjin Capsule
Identifier Type: -
Identifier Source: org_study_id