Pelvic Inflammatory DiseasePhase 2NCT02972151
Clinical Research of TCM on Pelvic Inflammatory Disease Sequelae
A Phase 2 study testing Comprehensive treatment of TCM and Expectant treatment in people with Pelvic Inflammatory Disease, run by Shanghai University of Traditional Chinese Medicine at 1 site in China.
Trial summary
The trial attempts to optimize, standardize and simplify the characteristic diagnosis and treatment program of the dominant diseases in our hospital-the sequelae of pelvic inflammatory disease, so as to make it suitable for clinical diagnosis and treatment in primary hospital. Read more about this study
- Who is it for?
- Ages 18 to 60 years, women only
- Conditions the study is for
- Pelvic Inflammatory Disease
- What is being tested?
- Comprehensive treatment of TCM and Expectant treatment
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 175 participants
- Where
- 1 siteChina
- Study dates
- Nov 2016to Dec 2018
- Phase
- Phase 2
- 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 18 to 60 years
- Women only
- No healthy volunteers
- Adult
Who may be able to join
- Patients with diagnostic criteria for the sequelae of pelvic inflammatory disease in Western medicine;
- Patients conforming to the criteria of TCM syndrome differentiation;
- Age 18--60 years old, married or sexual life;
- In this study, the voluntary participation, and signed informed consent;
Who cannot join
- Patients who do not meet the diagnostic criteria of Western medicine and traditional Chinese medicine dialectical typing standard;
- Persons with acute pelvic inflammatory disease;
- Related symptoms caused by diseasesGynecological tumor，specific vaginitis, acute cervicitis, pelvic congestion syndrome, endometriosis, adenomyosis, pelvic tuberculosis etc.
- Pregnant and lactating women;
- With severe primary disease, such as liver, kidney, heart, brain and hematopoietic system;
- Allergic to a variety of drugs or known to be allergic to the composition of the use of traditional Chinese Medicine;
- Patients taking part in other clinical trials;
- Suspect or do have a history of alcohol, drug abuse or according to the judgment of the researcher,other lesions or circumstances that have reduced the likelihood of entering a group or the complexity of entering a group,such as frequent changes in the working environment, the living environment is not stable,etc.
Trial locations and contacts
1 site in 1 country.
qianjue tang contact
China1 site
Shanghai Longhua Hosptial
Shanghai, Shanghai Municipality
lianwei xu, Doctor, 64385700-3912, sherryxlw@hotmail.com
lianwei xu, Doctor
About this study
Official title: Clinical Promotion Research of Complex Treatment With TCM to Diagnosis and Treatment on Different Syndrome Types of Pelvic Inflammatory Disease Sequelae
The trial attempts to optimize, standardize and simplify the characteristic diagnosis and treatment program of the dominant diseases in our hospital-the sequelae of pelvic inflammatory disease, so as to make it suitable for clinical diagnosis and treatment in primary hospital.
Read the detailed description
Sequelae of pelvic inflammatory disease (SPID) is a common cause of chronic pelvic pain, ectopic pregnancy and infertility, which seriously affects the physical and mental health of the patients, quality of life and family happiness. Western medicine for pelvic inflammatory disease sequelae is still lack of effective treatment methods, traditional Chinese medicine treatment of this disease has a unique advantage, with broad prospects for development..Standardized diagnosis and treatment scheme of this project on the one hand, improve and optimize the sequelae of pelvic inflammatory disease, including according to the dialectical treatment of herbal medicine combined with TCM (traditional Chinese medicine enema, external application of Chinese medicine intervention treatment); on the other hand, to observe the clinical curative effect and adverse reaction of traditional Chinese medicine comprehensive treatment.
- Conditions
- Pelvic Inflammatory Disease
- Being tested
- Comprehensive treatment of TCM, Expectant treatment
- 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.
Comprehensive treatment of TCMDrug
Also called Oral medicine and TCM enema, external treatment
Subjects were treated with comprehensive treatment of TCM including Oral medicine: 1 dose daily by our hospital pharmacy medicine room Decoction decoction, each agent 200ml, and the 2 ton service. 10 days for a course of treatment, continuous treatment of 3 courses; retention enema with traditional Chinese medicine oral drugs according to different types of concentrated decoction enema, each dose of medicine decocting 2 times, 2 days of external application of Chinese medicine: Chinese medicine enema; break into powder, into the bag, steam for 45 minutes, and so the temperature dropped to appropriate, will be installed a Chinese medicine bag used on patients with lower abdomen for 20 minutes. Above method, a course of treatment for 10 days, continuous treatment of 3 courses.
Expectant treatmentOther
Also called Do not give any treatment
Expectant treatment group patients were not treated during the observation period.（3 months after the start of the trial and 1 months after the end of the trial.）From the point of view of medical ethics, the expectant treatment group of patients at the end of the observation period, given the treatment of traditional Chinese medicine treatment group.
| Study group | Role | What they receive |
|---|---|---|
| Comprehensive treatment of TCM | Experimental | The intervention is Comprehensive treatment of TCM,which including Oral medicine ,tradition chinese medicine enema, external treatment. Receives: Drug: Comprehensive treatment of TCM |
| Expectant therapy | Active comparator | Expectant treatment group patients were not treated during the observation period.
（3 months after the start of the trial and 1 months after the end of the trial.） Receives: Other: Expectant treatment |
What is being measured
The primary outcome is the main question the study is designed to answer.
changes of The Symptom score
Patients are checked The Symptom score at 3 months after treatment.
Measured: 3 months after treatment
Secondary outcomes (2)
changes of The Hamilton Depression Scale (HAMD) (17 items)
Measured: 1 months after treatment, 2 months after treatment, 3 months after treatment and 1 months after drug withdrawal.
changes of The Sign score sheet
Measured: 1 months after treatment, 2 months after treatment, 3 months after treatment and 1 months after drug withdrawal
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted23 Nov 2016 (estimated)
- Study startNov 2016
- Primary completionDec 2018 (estimated)
- Study completionDec 2018 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Pelvic Inflammatory DiseaseStudies 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 2
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 175 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Shanghai University of Traditional Chinese Medicine
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- lianwei xu, Doctor, Principal investigator, Shanghai Longhua Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02972151
- Sponsor's protocol ID
- 42501190
- Status last verified
- Oct 2016
- First submitted
- 17 Nov 2016
- Last updated
- 23 Nov 2016
- Results posted
- No
- Data monitoring committee
- Yes
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 23 Nov 2016. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Clinical Promotion Research of Complex Treatment With TCM to Diagnosis and Treatment on Different Syndrome Types of Pelvic Inflammatory Disease Sequelae
- ClinicalTrials.gov ID
- NCT02972151
- Acronym / sponsor ID
- 42501190
- Conditions
- Pelvic Inflammatory Disease
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 175 participants (estimated)
- Lead sponsor
- Shanghai University of Traditional Chinese MedicineUniversity, hospital or other
- Study start
- Nov 2016
- Primary completion
- Dec 2018 (estimated)
- Study completion
- Dec 2018 (estimated)
- First posted
- 23 Nov 2016 (estimated)
- 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 trial attempts to optimize, standardize and simplify the characteristic diagnosis and treatment program of the dominant diseases in our hospital-the sequelae of pelvic inflammatory disease, so as to make it suitable for clinical diagnosis and treatment in primary hospital.
Detailed description
Sequelae of pelvic inflammatory disease (SPID) is a common cause of chronic pelvic pain, ectopic pregnancy and infertility, which seriously affects the physical and mental health of the patients, quality of life and family happiness. Western medicine for pelvic inflammatory disease sequelae is still lack of effective treatment methods, traditional Chinese medicine treatment of this disease has a unique advantage, with broad prospects for development..Standardized diagnosis and treatment scheme of this project on the one hand, improve and optimize the sequelae of pelvic inflammatory disease, including according to the dialectical treatment of herbal medicine combined with TCM (traditional Chinese medicine enema, external application of Chinese medicine intervention treatment); on the other hand, to observe the clinical curative effect and adverse reaction of traditional Chinese medicine comprehensive treatment.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Comprehensive treatment of TCM | Experimental | Drug: Comprehensive treatment of TCMThe intervention is Comprehensive treatment of TCM,which including Oral medicine ,tradition chinese medicine enema, external treatment. |
| Expectant therapy | Active comparator | Other: Expectant treatmentExpectant treatment group patients were not treated during the observation period. （3 months after the start of the trial and 1 months after the end of the trial.） |
Who may qualify
- Ages
- 18 to 60 years
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (4 listed)
- Patients with diagnostic criteria for the sequelae of pelvic inflammatory disease in Western medicine;
- Patients conforming to the criteria of TCM syndrome differentiation;
- Age 18--60 years old, married or sexual life;
- In this study, the voluntary participation, and signed informed consent;
Key exclusion criteria (8 listed)
- Patients who do not meet the diagnostic criteria of Western medicine and traditional Chinese medicine dialectical typing standard;
- Persons with acute pelvic inflammatory disease;
- Related symptoms caused by diseasesGynecological tumor，specific vaginitis, acute cervicitis, pelvic congestion syndrome, endometriosis, adenomyosis, pelvic tuberculosis etc.
- Pregnant and lactating women;
- With severe primary disease, such as liver, kidney, heart, brain and hematopoietic system;
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 |
|---|---|---|
| Comprehensive treatment of TCMAlso: Oral medicine and TCM enema, external treatmentSubjects were treated with comprehensive treatment of TCM including Oral medicine: 1 dose daily by our hospital pharmacy medicine room Decoction decoction, each agent 200ml, and the 2 ton service. 10 days for a course of treatment, continuous treatment of 3 courses; retention enema with traditional Chinese medicine oral drugs according to different types of concentrated decoction enema, each dose of medicine decocting 2 times, 2 days of external application of Chinese medicine: Chinese medicine enema; break into powder, into the bag, steam for 45 minutes, and so the temperature dropped to appropriate, will be installed a Chinese medicine bag used on patients with lower abdomen for 20 minutes. Above method, a course of treatment for 10 days, continuous treatment of 3 courses. | Drug | Comprehensive treatment of TCM |
| Expectant treatmentAlso: Do not give any treatmentExpectant treatment group patients were not treated during the observation period.（3 months after the start of the trial and 1 months after the end of the trial.）From the point of view of medical ethics, the expectant treatment group of patients at the end of the observation period, given the treatment of traditional Chinese medicine treatment group. | Other | Expectant therapy |
Primary outcome
changes of The Symptom score
Time frame: 3 months after treatment
Patients are checked The Symptom score at 3 months after treatment.
2 secondary outcomes
changes of The Hamilton Depression Scale (HAMD) (17 items)
Time frame: 1 months after treatment, 2 months after treatment, 3 months after treatment and 1 months after drug withdrawal.
changes of The Sign score sheet
Time frame: 1 months after treatment, 2 months after treatment, 3 months after treatment and 1 months after drug withdrawal
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 23 Nov 2016.
- 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.
qianjue tang contact
lianwei xu, Doctor principal investigator
Shanghai Longhua Hospital
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing Comprehensive treatment of TCM and Expectant treatment in people with Pelvic Inflammatory Disease, run by Shanghai University of Traditional Chinese Medicine at 1 site in China.
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 4 inclusion and 8 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 23 Nov 2016. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in China. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. 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 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
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 lianwei xu, Doctor (64385700-3912, sherryxlw@hotmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
changes of The Symptom score (time frame: 3 months after treatment). 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 23 Nov 2016.