Clinical Research of TCM on Pelvic Inflammatory Disease Sequelae
NCT ID: NCT02972151
Last Updated: 2016-11-23
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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UNKNOWN
PHASE2
175 participants
INTERVENTIONAL
2016-11-30
2018-12-31
Brief Summary
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Detailed Description
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Conditions
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
NONE
Study Groups
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Comprehensive treatment of TCM
The intervention is Comprehensive treatment of TCM,which including Oral medicine ,tradition chinese medicine enema, external treatment.
Comprehensive treatment of TCM
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 therapy
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.）
Expectant 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.
Interventions
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Comprehensive treatment of TCM
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 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.
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
2. Patients conforming to the criteria of TCM syndrome differentiation;
3. Age 18--60 years old, married or sexual life;
4. In this study, the voluntary participation, and signed informed consent;
Exclusion Criteria
2. Persons with acute pelvic inflammatory disease;
3. Related symptoms caused by diseasesGynecological tumor，specific vaginitis, acute cervicitis, pelvic congestion syndrome, endometriosis, adenomyosis, pelvic tuberculosis etc.
4. Pregnant and lactating women;
5. With severe primary disease, such as liver, kidney, heart, brain and hematopoietic system;
6. Allergic to a variety of drugs or known to be allergic to the composition of the use of traditional Chinese Medicine;
7. Patients taking part in other clinical trials;
8. 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.
18 Years
60 Years
FEMALE
No
Sponsors
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Shanghai University of Traditional Chinese Medicine
OTHER
Responsible Party
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Principal Investigators
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lianwei xu, Doctor
Role: PRINCIPAL_INVESTIGATOR
Shanghai Longhua Hospital
Locations
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Shanghai Longhua Hosptial
Shanghai, Shanghai Municipality, China
Countries
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Central Contacts
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qianjue tang
Role: CONTACT
Phone: 64385700-3912
Facility Contacts
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lianwei xu, Doctor
Role: primary
Other Identifiers
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42501190
Identifier Type: -
Identifier Source: org_study_id