A Clinical Study on Qianjin Capsule of Gynaecology Combined With Antibiotics for Pelvic Inflammatory Diseases (Damp-heat Stasis and Qi Deficiency Syndrome)

A Clinical Study on Qianjin Capsule of Gynaecology Combined With Antibiotics for Pelvic Inflammatory Diseases (Damp-heat Stasis and Qi Deficiency Syndrome)：a Randomized, Double Blind, Parallel Control of Positive Drugs, Multi-center Clinical Study

The purpose of this study is to evaluate the efficacy, safety of Qianjin Capsule of Gynaecology combined with antibiotics for pelvic inflammatory diseases (Damp-heat Stasis and Qi Deficiency Syndrome) for the short-term and long-term efficacy of traditional Chinese medicine in reducing the use of antibiotics, reducing the risk of clinical use of drugs.

Study Overview

• Status: Unknown
• Conditions: Pelvic Inflammatory Diseases
• Intervention / Treatment: Drug: Qianjin Capsule of Gynaecology

• Study Type: Interventional
• Enrollment (Anticipated): 184
• Phase: Phase 4

Contacts and Locations

• Study Contact: Name: Yanming Xie, BA; Phone Number: 86-13911112416; Email: ktzu2018@163.com
• Study Contact Backup: Name: Kun Ma, Doctor; Phone Number: 86-13521781839; Email: wlxing@126.com

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 20 years to 50 years (Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: Female

Description

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)4<McCormack<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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Double

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Qianjin Capsule of Gynaecology; On the basis of the antibiotic levofloxacin + metronidazole for 14 days, Gynecological Qianjin Capsule for 28 days. One of the levofloxacin quinolones has broadspectrum antimicrobial activity and strong antimicrobial activity. Metronidazole is mainly used to treat or prevent systemic or local infections caused by the abovementioned 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: Qianjin Capsule of Gynaecology; To evaluate the short-term and long-term efficacy of traditional Chinese medicine of Qianjin Capsule of Gynaecology in reducing the use of antibiotics, reducing the risk of clinical use of drugs.
Placebo Comparator: Antibiotics alone group; Levofloxacin + metronidazole for 14 days, and gynecological Qianjin capsule simulator for 28 days. One of the levofloxacin quinolones has broadspectrum 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 gramnegative bacteria. Bacterial activity. Metronidazole is mainly used to treat or prevent systemic or local infections caused by the abovementioned 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: Qianjin Capsule of Gynaecology; To evaluate the short-term and long-term efficacy of traditional Chinese medicine of Qianjin Capsule of Gynaecology in reducing the use of antibiotics, reducing the risk of clinical use of drugs.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
The MCCormack scale scores of 184 subjects will be assessed	assessment of the 70% reduction rate after treatment	Change from base line on the 56 days after discontinuation

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
The neutrophils of 184 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
The whole blood reduced viscosity from hemorheological tests of 184 participants will be assessed	assessment of whole blood viscosity returning to normal reference range	Change from base line on the 28 day of medication.
The plasma viscosity from hemorheological tests of 184 participants will be assessed	assessment of the plasma viscosity returning to normal reference range	Change from base line on the 28 day of medication.
The fibrinogen determination from hemorheological tests of 184 participants will be assessed	assessment of the fibrinogen determination returning to normal reference range	Change from base line on the 28 day of medication.
The CRP of 184 participants will be assessed	assessment of the CRP returning to normal reference range	Change from base line on the 28 day of medication.
The volume of liquid on B-mode of 184 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	After 28 days of medication
The white blood cells of 184 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
The TCM syndrome scores of 184 subjects will be assessed	assessment of the 70% reduction rate after treatment	Change from base line on the 56 days after discontinuation
The VAS score of 184 subjects will be assessed	assessment of the 70% reduction rate after treatment	Change from base line on the 56 days after discontinuation

Other Outcome Measures

Outcome Measure	Measure Description	Time Frame
Adverse events	Observe the incidence of adverse events after medication	Change from base line on the 21 day of medication and from 28 days on 56 days after the end of
Change of liver function	To observe whether ALT and AST are within the normal reference range after medication.	Change from base line on the 21 day of medication and from 28 days on 56 days after the end of
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 21 day of medication and from 28 days on 56 days after the end of

Collaborators and Investigators

• Sponsor: China Academy of Chinese Medical Sciences
• Collaborators: Peking University First Hospital; Peking Union Medical College Hospital; Chengdu University of Traditional Chinese Medicine; Xiyuan Hospital of China Academy of Chinese Medical Sciences; Beijing Obstetrics and Gynecology Hospital; Longhua Hospital; Third Hospital of Peking University; 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 Medicine
• Investigators: Principal Investigator: Yanming Xie, BA, Institute of Basic Research in Clinical Medicine, China Academy of Chinese

Study record dates

Study Major Dates

• Study Start (Anticipated): August 2, 2019
• Primary Completion (Anticipated): August 2, 2019
• Study Completion (Anticipated): December 31, 2020

Study Registration Dates

• First Submitted: July 11, 2019
• First Submitted That Met QC Criteria: July 23, 2019
• First Posted (Actual): July 24, 2019

Study Record Updates

• Last Update Posted (Actual): July 31, 2019
• Last Update Submitted That Met QC Criteria: July 29, 2019
• Last Verified: July 1, 2019

More Information

Terms related to this study

• Keywords: efficacy and safety; randomized; double blind; recurrence rate; parallel control; multi-center clinical study; Qianjin Capsule of Gynaecology
• Additional Relevant MeSH Terms: Infections; Adnexal Diseases; Pelvic Inflammatory Disease; Pelvic Infection
• Other Study ID Numbers: Qianjin Capsule

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No