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

Pelvic Inflammatory Diseases Clinical Trial

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

Clinical Trial Details — Status: Not yet recruiting

Administrative data

• NCT number: NCT04035785
• Other study ID #: Kangfu
• Status: Not yet recruiting
• Phase: Phase 4
• Start date: July 28, 2019
• Est. completion date: December 31, 2020

Study information

• Verified date: July 2019
• Source: China Academy of Chinese Medical Sciences
• Contact: Yanming Xie, BA
• Phone: 86-13911112416
• Email: ktzu2018[@]163.com
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Not yet recruiting
• Enrollment: 240
• Est. completion date: December 31, 2020
• Est. primary completion date: July 28, 2019
• Accepts healthy volunteers: No
• Gender: Female
• Age group: 20 Years to 50 Years

Eligibility

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

Related Conditions & MeSH terms

• Pelvic Inflammatory Disease
• Pelvic Inflammatory Diseases

Intervention

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.

Locations

Country	Name	City	State
n/a

Sponsors (11)

Lead Sponsor

Collaborator

China Academy of Chinese Medical Sciences

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

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	Adverse events	Observe the incidence of adverse events after medication	Change from base line on the 28 days of medication and 56 days after discontinuation
Other	Change of liver function	To observe whether ALT and AST are within the normal reference range after medication	Change from base line on the 28 days of medication and 56 days after discontinuation
Other	Change of renal function	To observe whether creatinine and urea nitrogen are within the normal reference range after treatment	Change from base line on the 28 days of medication and 56 days after discontinuation
Primary	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	The neutrophils of 240 participants will be assessed	assessment of neutrophils returning to normal reference range	Change from base line on the 28 days of medication and 56 days after discontinuation
Secondary	The whole blood reduced viscosity from hemorheological tests of 240 participants will be assessed	assessment of whole blood viscosity returning to normal reference range	Change from base line on the 28 days of medication and 56 days after discontinuation
Secondary	The plasma viscosity from hemorheological tests of 240 participants will be assessed	assessment of the plasma viscosity returning to normal reference range	Change from base line on the 28 days of medication and 56 days after discontinuation
Secondary	The CRP of 240 participants will be assessed	assessment of the CRP returning to normal reference range	Change from base line on the 28 days of medication and 56 days after discontinuation
Secondary	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	Change from base line on the 28 days of medication and 56 days after discontinuation
Secondary	The white blood cells of 240 participants will be assessed	assessment of the white blood returning to normal reference range	Change from base line on the 28 days of medication and 56 days after discontinuation
Secondary	The TCM syndrome 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	The VAS score of 240 subjects will be assessed	assessment of the 70% reduction rate after treatment	Change from base line on the 56 days after discontinuation