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Trial record 53 of 262 for:    Anti-Infective Agents AND Antibiotics, Antitubercular AND broad

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

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ClinicalTrials.gov Identifier: NCT04035785
Recruitment Status : Not yet recruiting
First Posted : July 29, 2019
Last Update Posted : July 29, 2019
Sponsor:
Collaborators:
Xiyuan Hospital of China Academy of Chinese Medical Sciences
Peking University First Hospital
Beijing Obstetrics and Gynecology Hospital
Longhua Hospital
Third Hospital of Peking University
Peking Union Medical College Hospital
First Affiliated Hospital of Tianjin University of Traditional Chinese Medicine
Shenzhen Maternal and Child Health Hospital
First Affiliated Hospital of Heilongjiang University of Traditional Chinese
Chengdu University of Traditional Chinese Medicine
Information provided by (Responsible Party):
Yanming Xie, China Academy of Chinese Medical Sciences

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.

Condition or disease Intervention/treatment Phase
Pelvic Inflammatory Diseases Drug: Kangfu Anti-inflammatory Suppository Phase 4

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 240 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double (Participant, Investigator)
Primary Purpose: Treatment
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
Estimated Study Start Date : July 28, 2019
Estimated Primary Completion Date : July 28, 2019
Estimated Study Completion Date : December 31, 2020

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
Experimental: 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.

Drug: 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.

Placebo Comparator: 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.

Drug: 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.




Primary Outcome Measures :
  1. The MCCormack scale scores of 240 subjects will be assessed [ Time Frame: Change from base line on the 56 days after discontinuation ]
    assessment of the 70% reduction rate after treatment


Secondary Outcome Measures :
  1. The neutrophils of 240 participants will be assessed [ Time Frame: Change from base line on the 28 days of medication and 56 days after discontinuation ]
    assessment of neutrophils returning to normal reference range

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

  3. The plasma viscosity from hemorheological tests of 240 participants will be assessed [ Time Frame: Change from base line on the 28 days of medication and 56 days after discontinuation ]
    assessment of the plasma viscosity returning to normal reference range

  4. The CRP of 240 participants will be assessed [ Time Frame: Change from base line on the 28 days of medication and 56 days after discontinuation ]
    assessment of the CRP returning to normal reference range

  5. The volume of liquid on B-mode of 240 subjects will be assessed [ Time Frame: Change from base line on the 28 days of medication and 56 days after discontinuation ]
    The changes of the volume of liquid on B-mode at different observation points before and after treatment will be assessed

  6. The white blood cells of 240 participants will be assessed [ Time Frame: Change from base line on the 28 days of medication and 56 days after discontinuation ]
    assessment of the white blood returning to normal reference range

  7. The TCM syndrome scores of 240 subjects will be assessed [ Time Frame: Change from base line on the 56 days after discontinuation ]
    assessment of the 70% reduction rate after treatment

  8. The VAS score of 240 subjects will be assessed [ Time Frame: Change from base line on the 56 days after discontinuation ]
    assessment of the 70% reduction rate after treatment


Other Outcome Measures:
  1. Adverse events [ Time Frame: Change from base line on the 28 days of medication and 56 days after discontinuation ]
    Observe the incidence of adverse events after medication

  2. Change of liver function [ Time Frame: Change from base line on the 28 days of medication and 56 days after discontinuation ]
    To observe whether ALT and AST are within the normal reference range after medication

  3. Change of renal function [ Time Frame: Change from base line on the 28 days of medication and 56 days after discontinuation ]
    To observe whether creatinine and urea nitrogen are within the normal reference range after treatment



Information from the National Library of Medicine

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Ages Eligible for Study:   20 Years to 50 Years   (Adult)
Sexes Eligible for Study:   Female
Accepts Healthy Volunteers:   No
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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04035785


Contacts
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Contact: Yanming Xie, BA 86-13911112416 ktzu2018@163.com
Contact: Kun Ma, Doctor 86-13521781839 wlxing@126.com

Sponsors and Collaborators
China Academy of Chinese Medical Sciences
Xiyuan Hospital of China Academy of Chinese Medical Sciences
Peking University First Hospital
Beijing Obstetrics and Gynecology Hospital
Longhua Hospital
Third Hospital of Peking University
Peking Union Medical College Hospital
First Affiliated Hospital of Tianjin University of Traditional Chinese Medicine
Shenzhen Maternal and Child Health Hospital
First Affiliated Hospital of Heilongjiang University of Traditional Chinese
Chengdu University of Traditional Chinese Medicine
Investigators
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Principal Investigator: Yanming Xie Institute of Basic Research in Clinical Medicine, China Academy of Chinese

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Responsible Party: Yanming Xie, Deputy director, China Academy of Chinese Medical Sciences
ClinicalTrials.gov Identifier: NCT04035785     History of Changes
Other Study ID Numbers: Kangfu
First Posted: July 29, 2019    Key Record Dates
Last Update Posted: July 29, 2019
Last Verified: July 2019
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by Yanming Xie, China Academy of Chinese Medical Sciences:
Kangfu Anti-inflammatory Suppository
efficacy and safety
recurrence rate
randomized
double blind
parallel control
multi-center clinical study
Additional relevant MeSH terms:
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Pelvic Inflammatory Disease
Pelvic Infection
Infection
Adnexal Diseases
Genital Diseases, Female
Anti-Bacterial Agents
Antibiotics, Antitubercular
Anti-Inflammatory Agents
Anti-Infective Agents
Antitubercular Agents