Clinical trial NCT04035785: 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
Overall status: UNKNOWN
Phase: PHASE4
Conditions: Pelvic Inflammatory Diseases
Keywords: Kangfu Anti-inflammatory Suppository
efficacy and safety
recurrence rate
randomized
double blind
parallel control
multi-center clinical study
Lead sponsor: China Academy of Chinese Medical Sciences
Sponsor class: OTHER
Collaborators: name: Xiyuan Hospital of China Academy of Chinese Medical Sciences
name: Peking University First Hospital
name: Beijing Obstetrics and Gynecology Hospital
name: Longhua Hospital
name: Third Hospital of Peking University
name: Peking Union Medical College Hospital
name: First Affiliated Hospital of Tianjin University of Traditional Chinese Medicine
name: Shenzhen Maternal and Child Health Hospital
name: First Affiliated Hospital of Heilongjiang University of Traditional Chinese
name: Chengdu University of Traditional Chinese Medicine
First posted: 2019-07-29
Enrollment: 240
Sex: FEMALE
Minimum age (years): 20
Maximum age (years): 50
Standard ages: ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.


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

Primary outcomes:
measure: The MCCormack scale scores of 240 subjects will be assessed
timeFrame: Change from base line on the 56 days after discontinuation
Secondary outcomes:
measure: The neutrophils of 240 participants will be assessed
timeFrame: Change from base line on the 28 days of medication and 56 days after discontinuation
measure: The whole blood reduced viscosity from hemorheological tests of 240 participants will be assessed
timeFrame: Change from base line on the 28 days of medication and 56 days after discontinuation
measure: The plasma viscosity from hemorheological tests of 240 participants will be assessed
timeFrame: Change from base line on the 28 days of medication and 56 days after discontinuation
measure: The CRP of 240 participants will be assessed
timeFrame: Change from base line on the 28 days of medication and 56 days after discontinuation
measure: The volume of liquid on B-mode of 240 subjects will be assessed
timeFrame: Change from base line on the 28 days of medication and 56 days after discontinuation
measure: The white blood cells of 240 participants will be assessed
timeFrame: Change from base line on the 28 days of medication and 56 days after discontinuation
measure: The TCM syndrome scores of 240 subjects will be assessed
timeFrame: Change from base line on the 56 days after discontinuation
measure: The VAS score of 240 subjects will be assessed
timeFrame: Change from base line on the 56 days after discontinuation
Other outcomes:
measure: Adverse events
timeFrame: Change from base line on the 28 days of medication and 56 days after discontinuation
measure: Change of liver function
timeFrame: Change from base line on the 28 days of medication and 56 days after discontinuation
measure: Change of renal function
timeFrame: Change from base line on the 28 days of medication and 56 days after discontinuation
Locations:
Study officials:
affiliation: Institute of Basic Research in Clinical Medicine, China Academy of Chinese
name: Yanming Xie
role: PRINCIPAL_INVESTIGATOR
References: