Clinical Research of TCM on Pelvic Inflammatory Disease Sequelae
Clinical Promotion Research of Complex Treatment With TCM to Diagnosis and Treatment on Different Syndrome Types of Pelvic Inflammatory Disease Sequelae
1 other identifier
interventional
175
1 country
1
Brief 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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for phase_2
Started Nov 2016
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
November 1, 2016
CompletedFirst Submitted
Initial submission to the registry
November 17, 2016
CompletedFirst Posted
Study publicly available on registry
November 23, 2016
CompletedPrimary Completion
Last participant's last visit for primary outcome
December 1, 2018
CompletedStudy Completion
Last participant's last visit for all outcomes
December 1, 2018
CompletedNovember 23, 2016
October 1, 2016
2.1 years
November 17, 2016
November 21, 2016
Conditions
Outcome Measures
Primary Outcomes (1)
changes of The Symptom score
Patients are checked The Symptom score at 3 months after treatment.
3 months after treatment
Secondary Outcomes (2)
changes of The Hamilton Depression Scale (HAMD) (17 items)
1 months after treatment, 2 months after treatment, 3 months after treatment and 1 months after drug withdrawal.
changes of The Sign score sheet
1 months after treatment, 2 months after treatment, 3 months after treatment and 1 months after drug withdrawal
Study Arms (2)
Comprehensive treatment of TCM
EXPERIMENTALThe intervention is Comprehensive treatment of TCM,which including Oral medicine ,tradition chinese medicine enema, external treatment.
Expectant therapy
ACTIVE COMPARATORExpectant 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.）
Interventions
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 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.
Eligibility Criteria
You may qualify if:
- 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;
You may not qualify if:
- 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.
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
Shanghai Longhua Hosptial
Shanghai, Shanghai Municipality, China
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
lianwei xu, Doctor
Shanghai Longhua Hospital
Central Study Contacts
Study Design
- Study Type
- interventional
- Phase
- phase 2
- Allocation
- RANDOMIZED
- Masking
- NONE
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
November 17, 2016
First Posted
November 23, 2016
Study Start
November 1, 2016
Primary Completion
December 1, 2018
Study Completion
December 1, 2018
Last Updated
November 23, 2016
Record last verified: 2016-10
Data Sharing
- IPD Sharing
- Will not share