Pelvic Inflammatory DiseasesPhase 4NCT04031664
A Clinical Study on Qianjin Capsule of Gynaecology Combined With Antibiotics for Pelvic Inflammatory Diseases (Damp-heat Stasis and Qi Deficiency Syndrome)
A Phase 4 study testing Qianjin Capsule of Gynaecology in people with Pelvic Inflammatory Diseases, run by China Academy of Chinese Medical Sciences.
Trial 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… Read more about this study
- Who is it for?
- Ages 20 to 50 years, women only
- Conditions the study is for
- Pelvic Inflammatory Diseases
- What is being tested?
- Qianjin Capsule of Gynaecology
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 184 participants
- Where
- No sites listed yet
- Study dates
- 2 Aug 2019to 31 Dec 2020
- Phase
- Phase 4
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 20 to 50 years
- Women only
- No healthy volunteers
- Adult
Who may be able to join
- (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.
Who cannot join
- (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;
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- (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
Trial locations and contacts
No sites are listed yet.
About this study
Official title: 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.
- Conditions
- Pelvic Inflammatory Diseases
- Being tested
- Qianjin Capsule of Gynaecology
- Keywords
- Qianjin Capsule of Gynaecology, efficacy and safety, recurrence rate, randomized, double blind, parallel control, multi-center clinical study
- Medical subject headings
- Pelvic Inflammatory Disease
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Qianjin Capsule of GynaecologyDrug
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.
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: Drug: Qianjin Capsule of Gynaecology |
| 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. Receives: Drug: Qianjin Capsule of Gynaecology |
What is being measured
The primary outcome is the main question the study is designed to answer.
The MCCormack scale scores of 184 subjects will be assessed
assessment of the 70% reduction rate after treatment
Measured: Change from base line on the 56 days after discontinuation
Secondary outcomes (9)
The neutrophils of 184 participants will be assessed
assessment of neutrophils returning to normal reference range
Measured: 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
Measured: 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
Measured: 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
Measured: 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
Measured: 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
Measured: 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
Measured: 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
Measured: 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
Measured: Change from base line on the 56 days after discontinuation
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted24 Jul 2019
- Study start2 Aug 2019 (estimated)
- Primary completion2 Aug 2019 (estimated)
- Study completion31 Dec 2020 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Pelvic Inflammatory DiseasesStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 4
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Participant, Investigator
- Enrolment
- 184 participants (estimated)
Sponsor and investigators
- Lead sponsor
- China Academy of Chinese Medical Sciences
- Sponsor type
- University, hospital or other
- Collaborators
- Xiyuan Hospital of China Academy of Chinese Medical Sciences, Peking University First Hospital, Beijing Obstetrics and Gynecology Hospital, Longhua Hospital, Peking University Third Hospital, Peking Union Medical College Hospital, The 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
- Responsible party
- Principal investigator, Yanming Xie, China Academy of Chinese Medical Sciences
- Investigators
- Yanming Xie, BA, Principal investigator, Institute of Basic Research in Clinical Medicine, China Academy of Chinese
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04031664
- Sponsor's protocol ID
- Qianjin Capsule
- Status last verified
- Jul 2019
- First submitted
- 11 Jul 2019
- Last updated
- 31 Jul 2019
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 31 Jul 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- 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
- ClinicalTrials.gov ID
- NCT04031664
- Acronym / sponsor ID
- Qianjin Capsule
- Conditions
- Pelvic Inflammatory Diseases
- Keywords
- Qianjin Capsule of Gynaecology, efficacy and safety, recurrence rate, randomized, double blind, parallel control, multi-center clinical study
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 184 participants (estimated)
- Lead sponsor
- China Academy of Chinese Medical SciencesUniversity, hospital or other
- Collaborators
- Xiyuan Hospital of China Academy of Chinese Medical Sciences, Peking University First Hospital, Beijing Obstetrics and Gynecology Hospital, Longhua Hospital, Peking University Third Hospital, Peking Union Medical College Hospital, The 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
- Study start
- 2 Aug 2019 (estimated)
- Primary completion
- 2 Aug 2019 (estimated)
- Study completion
- 31 Dec 2020 (estimated)
- First posted
- 24 Jul 2019 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, investigator)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Qianjin Capsule of Gynaecology | Experimental | Drug: Qianjin Capsule of GynaecologyOn 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 | Drug: Qianjin Capsule of GynaecologyLevofloxacin + 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. |
Who may qualify
- Ages
- 20 to 50 years
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (6 listed)
- (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;
Key exclusion criteria (11 listed)
- (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;
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Qianjin Capsule of GynaecologyTo 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. | Drug | Antibiotics alone group, Qianjin Capsule of Gynaecology |
Primary outcome
The MCCormack scale scores of 184 subjects will be assessed
Time frame: Change from base line on the 56 days after discontinuation
assessment of the 70% reduction rate after treatment
9 secondary outcomes
The neutrophils of 184 participants will be assessed
Time frame: 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
Time frame: Change from base line on the 28 day of medication.
The plasma viscosity from hemorheological tests of 184 participants will be assessed
Time frame: Change from base line on the 28 day of medication.
The fibrinogen determination from hemorheological tests of 184 participants will be assessed
Time frame: Change from base line on the 28 day of medication.
The CRP of 184 participants will be assessed
Time frame: Change from base line on the 28 day of medication.
The volume of liquid on B-mode of 184 subjects will be assessed
Time frame: After 28 days of medication
The white blood cells of 184 participants will be assessed
Time frame: 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
Time frame: Change from base line on the 56 days after discontinuation
The VAS score of 184 subjects will be assessed
Time frame: Change from base line on the 56 days after discontinuation
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 31 Jul 2019.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Yanming Xie, BA principal investigator
Institute of Basic Research in Clinical Medicine, China Academy of Chinese
Questions about this trial
What is this clinical trial studying?
A Phase 4 study testing Qianjin Capsule of Gynaecology in people with Pelvic Inflammatory Diseases, run by China Academy of Chinese Medical Sciences.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 6 inclusion and 11 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 31 Jul 2019. Status can change between updates, so confirm with the study contact before making plans.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Yanming Xie, BA (86-13911112416, ktzu2018@163.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
The MCCormack scale scores of 184 subjects will be assessed (time frame: Change from base line on the 56 days after discontinuation). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 31 Jul 2019.