Overview

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

Status:
Unknown status
Trial end date:
2020-12-31
Target enrollment:
0
Participant gender:
Female
Summary
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.
Phase:
Phase 4
Accepts Healthy Volunteers?
No
Details
Lead Sponsor:
China Academy of Chinese Medical Sciences
Collaborators:
Beijing Obstetrics and Gynecology Hospital
Chengdu University of Traditional Chinese Medicine
First Affiliated Hospital of Heilongjiang University of Traditional Chinese Medicine
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
Treatments:
Anti-Bacterial Agents
Antibiotics, Antitubercular
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)4
- (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