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

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

Status

UNKNOWN

Phases

Phase 4

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT04035785

Enrollment

240

Registered

2019-07-29

Start date

2019-07-28

Completion date

2020-12-31

Last updated

2019-07-29

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Pelvic Inflammatory Diseases

Keywords

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

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.

Interventions

DRUGKangfu 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.

Study design

Allocation

RANDOMIZED

Intervention model

PARALLEL

Primary purpose

TREATMENT

Masking

DOUBLE (Subject, Investigator)

Eligibility

Sex/Gender

FEMALE

Age

20 Years to 50 Years

Healthy volunteers

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.

Design outcomes

Primary

Measure	Time frame	Description
The MCCormack scale scores of 240 subjects will be assessed	Change from base line on the 56 days after discontinuation	assessment of the 70% reduction rate after treatment

Secondary

Measure	Time frame	Description
The CRP of 240 participants will be assessed	Change from base line on the 28 days of medication and 56 days after discontinuation	assessment of the CRP returning to normal reference range
The white blood cells of 240 participants will be assessed	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
The TCM syndrome scores of 240 subjects will be assessed	Change from base line on the 56 days after discontinuation	assessment of the 70% reduction rate after treatment
The VAS score of 240 subjects will be assessed	Change from base line on the 56 days after discontinuation	assessment of the 70% reduction rate after treatment
The neutrophils of 240 participants will be assessed	Change from base line on the 28 days of medication and 56 days after discontinuation	assessment of neutrophils returning to normal reference range
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	assessment of whole blood viscosity returning to normal reference range
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	assessment of the plasma viscosity returning to normal reference range
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	The changes of the volume of liquid on B-mode at different observation points before and after treatment will be assessed

Other

Measure	Time frame	Description
Change of renal function	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
Change of liver function	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
Adverse events	Change from base line on the 28 days of medication and 56 days after discontinuation	Observe the incidence of adverse events after medication

Contacts

Primary ContactYanming Xie, BA

ktzu2018@163.com86-13911112416

Backup ContactKun Ma, Doctor

wlxing@126.com86-13521781839

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026