Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| Name | Class |
|---|---|
| Xiyuan Hospital of China Academy of Chinese Medical Sciences | OTHER |
| Peking University First Hospital | OTHER |
| Beijing Obstetrics and Gynecology Hospital | OTHER |
Not provided
Not provided
Not provided
Not provided
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.
Not provided
Not provided
Not provided
Not provided
Not provided
| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Qianjin Capsule of Gynaecology | Experimental | 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. |
|
| Antibiotics alone group | Placebo Comparator | 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. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Qianjin Capsule of Gynaecology | Drug | 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. |
| 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 |
| 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 |
| 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. |
Inclusion Criteria:
Not provided
Not provided
Not provided
Not provided
| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Yanming Xie, BA | Contact | 86-13911112416 | ktzu2018@163.com | |
| Kun Ma, Doctor | Contact | 86-13521781839 | wlxing@126.com |
| Name | Affiliation | Role |
|---|---|---|
| Yanming Xie, BA | Institute of Basic Research in Clinical Medicine, China Academy of Chinese | Principal Investigator |
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| Longhua Hospital |
| OTHER |
| Peking University Third Hospital | OTHER |
| Peking Union Medical College Hospital | OTHER |
| The First Affiliated Hospital of Tianjin University of Traditional Chinese Medicine | OTHER |
| Shenzhen Maternal and Child Health Hospital | UNKNOWN |
| First Affiliated Hospital of Heilongjiang Chinese Medicine University | OTHER |
| Chengdu University of Traditional Chinese Medicine | OTHER |
Not provided
Not provided
Not provided
Double (Participant, Investigator)
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 |
| 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 |
| ID | Term |
|---|---|
| D000292 | Pelvic Inflammatory Disease |
| ID | Term |
|---|---|
| D034161 | Pelvic Infection |
| D007239 | Infections |
| D000291 | Adnexal Diseases |
| D005831 | Genital Diseases, Female |
| D052776 | Female Urogenital Diseases |
| D005261 | Female Urogenital Diseases and Pregnancy Complications |
| D000091642 | Urogenital Diseases |
| D000091662 | Genital Diseases |
Not provided
Not provided