Pelvic Inflammatory Diseases
Conditions
Keywords
Qianjin Capsule of Gynaecology, efficacy and safety, recurrence rate, randomized, double blind, parallel control, multi-center clinical study
Brief 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.
Interventions
DRUGQianjin 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.
Sponsors
Xiyuan Hospital of China Academy of Chinese Medical Sciences
Peking University First Hospital
Beijing Obstetrics and Gynecology Hospital
Longhua Hospital
Third Hospital of Peking University
Peking Union Medical College Hospital
First Affiliated Hospital of Tianjin University of Traditional Chinese Medicine
Shenzhen Maternal and Child Health Hospital
First Affiliated Hospital of Heilongjiang Chinese Medicine University
Chengdu University of Traditional Chinese Medicine
China Academy of Chinese Medical Sciences
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
DOUBLE (Subject, Investigator)
Masking description
Double (Participant, Investigator)
Eligibility
Sex/Gender
FEMALE
Age
20 Years to 50 Years
Healthy volunteers
No
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.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| The MCCormack scale scores of 184 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 whole blood reduced viscosity from hemorheological tests of 184 participants will be assessed | Change from base line on the 28 day of medication. | assessment of whole blood viscosity returning to normal reference range |
| The plasma viscosity from hemorheological tests of 184 participants will be assessed | Change from base line on the 28 day of medication. | assessment of the plasma viscosity returning to normal reference range |
| The fibrinogen determination from hemorheological tests of 184 participants will be assessed | Change from base line on the 28 day of medication. | assessment of the fibrinogen determination returning to normal reference range |
| The CRP of 184 participants will be assessed | Change from base line on the 28 day of medication. | assessment of the CRP returning to normal reference range |
| The volume of liquid on B-mode of 184 subjects will be assessed | After 28 days of medication | The changes of the volume of liquid on B-mode at different observation points before and after treatment will be assessed |
| The neutrophils of 184 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 TCM syndrome scores of 184 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 184 subjects will be assessed | Change from base line on the 56 days after discontinuation | assessment of the 70% reduction rate after treatment |
| The white blood cells of 184 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 |
Other
| Measure | Time frame | Description |
|---|---|---|
| Change of liver function | Change from base line on the 21 day of medication and from 28 days on 56 days after the end of | To observe whether ALT and AST are within the normal reference range after medication. |
| Change of renal function | Change from base line on the 21 day of medication and from 28 days on 56 days after the end of | To observe whether creatinine and urea nitrogen are within the normal reference range after treatment. |
| Adverse events | Change from base line on the 21 day of medication and from 28 days on 56 days after the end of | Observe the incidence of adverse events after medication |
Contacts
Primary ContactYanming Xie, BA
Backup ContactKun Ma, Doctor
Outcome results
None listed