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

NCT04035785 | Unknown Phase 4 DMC

• 1 other identifier: Kangfu
• Study Type: interventional
• Target: 240
• Locations: 0 countries
• Sites: N/A

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.

Conditions

Pelvic Inflammatory Diseases

Keywords

Kangfu Anti-inflammatory Suppository; efficacy and safety; recurrence rate; randomized; double blind; parallel control; multi-center clinical study

Outcome Measures

Primary Outcomes (1)

• The MCCormack scale scores of 240 subjects will be assessed

  assessment of the 70% reduction rate after treatment

  Change from base line on the 56 days after discontinuation

Secondary Outcomes (8)

• The neutrophils of 240 participants will be assessed

  Change from base line on the 28 days of medication and 56 days after discontinuation

• The whole blood reduced viscosity from hemorheological tests of 240 participants will be assessed

  Change from base line on the 28 days of medication and 56 days after discontinuation

• The plasma viscosity from hemorheological tests of 240 participants will be assessed

  Change from base line on the 28 days of medication and 56 days after discontinuation

• The CRP of 240 participants will be assessed

  Change from base line on the 28 days of medication and 56 days after discontinuation

• The volume of liquid on B-mode of 240 subjects will be assessed

  Change from base line on the 28 days of medication and 56 days after discontinuation

Other Outcomes (3)

• Adverse events

  Change from base line on the 28 days of medication and 56 days after discontinuation

• Change of liver function

  Change from base line on the 28 days of medication and 56 days after discontinuation

• Change of renal function

  Change from base line on the 28 days of medication and 56 days after discontinuation

Study Arms (2)

Kangfu anti-inflammatory suppository

EXPERIMENTAL

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

antibiotics alone group

PLACEBO COMPARATOR

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

Interventions

Kangfu Anti-inflammatory Suppository 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.

Kangfu anti-inflammatory suppository; antibiotics alone group

Eligibility Criteria

• Age: 20 Years - 50 Years
• Sex: female
• Healthy Volunteers: No
• Age Groups: Adult (18-64)

You may qualify if:

• (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%;

You may not qualify if:

• (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

Sponsors & Collaborators

• China Academy of Chinese Medical Sciences: lead
• Xiyuan Hospital of China Academy of Chinese Medical Sciences: collaborator
• Peking University First Hospital: collaborator
• Beijing Obstetrics and Gynecology Hospital: collaborator
• Longhua Hospital: collaborator
• Third Hospital of Peking University: collaborator
• Peking Union Medical College Hospital: collaborator
• First Affiliated Hospital of Tianjin University of Traditional Chinese Medicine: collaborator
• Shenzhen Maternal and Child Health Hospital: collaborator
• First Affiliated Hospital of Heilongjiang Chinese Medicine University: collaborator
• Chengdu University of Traditional Chinese Medicine: collaborator

MeSH Terms

Conditions

Pelvic Inflammatory Disease

Condition Hierarchy (Ancestors)

Pelvic Infection; Infections; Adnexal Diseases; Genital Diseases, Female; Female Urogenital Diseases; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Genital Diseases

Study Officials

• Yanming Xie

  Institute of Basic Research in Clinical Medicine, China Academy of Chinese

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Yanming Xie, BA

CONTACT

86-13911112416; ktzu2018@163.com

Kun Ma, Doctor

CONTACT

86-13521781839; wlxing@126.com

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, INVESTIGATOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Deputy director

Study Record Dates

• First Submitted: July 11, 2019
• First Posted: July 29, 2019
• Study Start: July 28, 2019
• Primary Completion: July 28, 2019
• Study Completion: December 31, 2020
• Last Updated: July 29, 2019

Record last verified: 2019-07

Data Sharing

• IPD Sharing: Will not share