Back to resultsClinical Research of TCM on Pelvic Inflammatory Disease Sequelae
Primary Purpose
Pelvic Inflammatory Disease
Status
Unknown status
Phase
Phase 2
Locations
China
Study Type
Interventional
Intervention
Comprehensive treatment of TCM
Expectant treatment
Sponsored by
About this trial
This is an interventional treatment trial for Pelvic Inflammatory Disease
Eligibility Criteria
Inclusion Criteria:
- 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;
Exclusion Criteria:
- 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.
Sites / Locations
- Shanghai Longhua Hosptial
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
Active Comparator
Arm Label
Comprehensive treatment of TCM
Expectant therapy
Arm Description
The intervention is Comprehensive treatment of TCM,which including Oral medicine ,tradition chinese medicine enema, external 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.）
Outcomes
Primary Outcome Measures
changes of The Symptom score
Patients are checked The Symptom score at 3 months after treatment.
Secondary Outcome Measures
changes of The Hamilton Depression Scale (HAMD) (17 items)
changes of The Sign score sheet
Full Information
NCT ID
NCT02972151
First Posted
November 17, 2016
Last Updated
November 21, 2016
Sponsor
Shanghai University of Traditional Chinese Medicine
1. Study Identification
Unique Protocol Identification Number
NCT02972151
Brief Title
Clinical Research of TCM on Pelvic Inflammatory Disease Sequelae
Official Title
Clinical Promotion Research of Complex Treatment With TCM to Diagnosis and Treatment on Different Syndrome Types of Pelvic Inflammatory Disease Sequelae
Study Type
Interventional
2. Study Status
Record Verification Date
October 2016
Overall Recruitment Status
Unknown status
Study Start Date
November 2016 (undefined)
Primary Completion Date
December 2018 (Anticipated)
Study Completion Date
December 2018 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Shanghai University of Traditional Chinese Medicine
4. Oversight
Data Monitoring Committee
Yes
5. Study Description
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.
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Pelvic Inflammatory Disease
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 2
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
175 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
Comprehensive treatment of TCM
Arm Type
Experimental
Arm Description
The intervention is Comprehensive treatment of TCM,which including Oral medicine ,tradition chinese medicine enema, external treatment.
Arm Title
Expectant therapy
Arm Type
Active Comparator
Arm Description
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.）
Intervention Type
Drug
Intervention Name(s)
Comprehensive treatment of TCM
Other Intervention Name(s)
Oral medicine and TCM enema, external treatment
Intervention Description
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.
Intervention Type
Other
Intervention Name(s)
Expectant treatment
Other Intervention Name(s)
Do not give any treatment
Intervention Description
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.
Primary Outcome Measure Information:
Title
changes of The Symptom score
Description
Patients are checked The Symptom score at 3 months after treatment.
Time Frame
3 months after treatment
Secondary Outcome Measure Information:
Title
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.
Title
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
10. Eligibility
Sex
Female
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
60 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
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;
Exclusion Criteria:
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.
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
lianwei xu, Doctor
Phone
64385700-3912
Email
sherryxlw@hotmail.com
First Name & Middle Initial & Last Name or Official Title & Degree
qianjue tang
Phone
64385700-3912
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
lianwei xu, Doctor
Organizational Affiliation
Shanghai Longhua Hospital
Official's Role
Principal Investigator
Facility Information:
Facility Name
Shanghai Longhua Hosptial
City
Shanghai
State/Province
Shanghai
Country
China
Facility Contact:
First Name & Middle Initial & Last Name & Degree
lianwei xu, Doctor
Phone
64385700-3912
Email
sherryxlw@hotmail.com
First Name & Middle Initial & Last Name & Degree
lianwei xu, Doctor
12. IPD Sharing Statement
Plan to Share IPD
No
Learn more about this trial
Clinical Research of TCM on Pelvic Inflammatory Disease Sequelae
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