Back to resultsA Clinical Study on Kangfu Anti-inflammatory Suppository of Gynaecology Combined With Antibiotics for Pelvic Inflammatory Diseases (Evidence of Dampness and Heat Accumulation)
Primary Purpose
Pelvic Inflammatory Diseases
Status
Unknown status
Phase
Phase 4
Locations
Study Type
Interventional
Intervention
Kangfu Anti-inflammatory Suppository
Sponsored by
About this trial
This is an interventional treatment trial for Pelvic Inflammatory Diseases focused on measuring Kangfu Anti-inflammatory Suppository, efficacy and safety, recurrence rate, randomized, double blind, parallel control, multi-center clinical study
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
Sites / Locations
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
Placebo Comparator
Arm Label
Kangfu anti-inflammatory suppository
antibiotics alone group
Arm Description
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.
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.
Outcomes
Primary Outcome Measures
The MCCormack scale scores of 240 subjects will be assessed
assessment of the 70% reduction rate after treatment
Secondary Outcome Measures
The neutrophils of 240 participants will be assessed
assessment of neutrophils returning to normal reference range
The whole blood reduced viscosity from hemorheological tests of 240 participants will be assessed
assessment of whole blood viscosity returning to normal reference range
The plasma viscosity from hemorheological tests of 240 participants will be assessed
assessment of the plasma viscosity returning to normal reference range
The CRP of 240 participants will be assessed
assessment of the CRP returning to normal reference range
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
The white blood cells of 240 participants will be assessed
assessment of the white blood returning to normal reference range
The TCM syndrome scores of 240 subjects will be assessed
assessment of the 70% reduction rate after treatment
The VAS score of 240 subjects will be assessed
assessment of the 70% reduction rate after treatment
Full Information
NCT ID
NCT04035785
First Posted
July 11, 2019
Last Updated
July 25, 2019
Sponsor
China Academy of Chinese Medical Sciences
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
1. Study Identification
Unique Protocol Identification Number
NCT04035785
Brief Title
A Clinical Study on Kangfu Anti-inflammatory Suppository of Gynaecology Combined With Antibiotics for Pelvic Inflammatory Diseases (Evidence of Dampness and Heat Accumulation)
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
Study Type
Interventional
2. Study Status
Record Verification Date
July 2019
Overall Recruitment Status
Unknown status
Study Start Date
July 28, 2019 (Anticipated)
Primary Completion Date
July 28, 2019 (Anticipated)
Study Completion Date
December 31, 2020 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
China Academy of Chinese Medical Sciences
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
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
Yes
5. Study Description
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Pelvic Inflammatory Diseases
Keywords
Kangfu Anti-inflammatory Suppository, efficacy and safety, recurrence rate, randomized, double blind, parallel control, multi-center clinical study
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 4
Interventional Study Model
Parallel Assignment
Masking
ParticipantInvestigator
Allocation
Randomized
Enrollment
240 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
Kangfu anti-inflammatory suppository
Arm Type
Experimental
Arm Description
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.
Arm Title
antibiotics alone group
Arm Type
Placebo Comparator
Arm Description
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.
Intervention Type
Drug
Intervention Name(s)
Kangfu Anti-inflammatory Suppository
Intervention Description
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 Measure Information:
Title
The MCCormack scale scores of 240 subjects will be assessed
Description
assessment of the 70% reduction rate after treatment
Time Frame
Change from base line on the 56 days after discontinuation
Secondary Outcome Measure Information:
Title
The neutrophils of 240 participants will be assessed
Description
assessment of neutrophils returning to normal reference range
Time Frame
Change from base line on the 28 days of medication and 56 days after discontinuation
Title
The whole blood reduced viscosity from hemorheological tests of 240 participants will be assessed
Description
assessment of whole blood viscosity returning to normal reference range
Time Frame
Change from base line on the 28 days of medication and 56 days after discontinuation
Title
The plasma viscosity from hemorheological tests of 240 participants will be assessed
Description
assessment of the plasma viscosity returning to normal reference range
Time Frame
Change from base line on the 28 days of medication and 56 days after discontinuation
Title
The CRP of 240 participants will be assessed
Description
assessment of the CRP returning to normal reference range
Time Frame
Change from base line on the 28 days of medication and 56 days after discontinuation
Title
The volume of liquid on B-mode of 240 subjects will be assessed
Description
The changes of the volume of liquid on B-mode at different observation points before and after treatment will be assessed
Time Frame
Change from base line on the 28 days of medication and 56 days after discontinuation
Title
The white blood cells of 240 participants will be assessed
Description
assessment of the white blood returning to normal reference range
Time Frame
Change from base line on the 28 days of medication and 56 days after discontinuation
Title
The TCM syndrome scores of 240 subjects will be assessed
Description
assessment of the 70% reduction rate after treatment
Time Frame
Change from base line on the 56 days after discontinuation
Title
The VAS score of 240 subjects will be assessed
Description
assessment of the 70% reduction rate after treatment
Time Frame
Change from base line on the 56 days after discontinuation
Other Pre-specified Outcome Measures:
Title
Adverse events
Description
Observe the incidence of adverse events after medication
Time Frame
Change from base line on the 28 days of medication and 56 days after discontinuation
Title
Change of liver function
Description
To observe whether ALT and AST are within the normal reference range after medication
Time Frame
Change from base line on the 28 days of medication and 56 days after discontinuation
Title
Change of renal function
Description
To observe whether creatinine and urea nitrogen are within the normal reference range after treatment
Time Frame
Change from base line on the 28 days of medication and 56 days after discontinuation
10. Eligibility
Sex
Female
Minimum Age & Unit of Time
20 Years
Maximum Age & Unit of Time
50 Years
Accepts Healthy Volunteers
No
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
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Yanming Xie, BA
Phone
86-13911112416
Email
ktzu2018@163.com
First Name & Middle Initial & Last Name or Official Title & Degree
Kun Ma, Doctor
Phone
86-13521781839
Email
wlxing@126.com
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Yanming Xie
Organizational Affiliation
Institute of Basic Research in Clinical Medicine, China Academy of Chinese
Official's Role
Principal Investigator
12. IPD Sharing Statement
Plan to Share IPD
No
Learn more about this trial
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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