A Phase 2 interventional study of Comprehensive treatment of TCM and Expectant treatment in Pelvic Inflammatory Disease, sponsored by Shanghai University of Traditional Chinese Medicine. Status unknown at 1 site in China. Open to female participants aged 18 Years to 60 Years. Per ClinicalTrials.gov, last updated 2016-11-23.
Sponsored by Shanghai University of Traditional Chinese Medicine · Phase 2, Interventional, and Treatment
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.
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.
37 studies on the registry are indexed under Pelvic Inflammatory Disease; 5 are open to participants now.
This study's planned enrollment of 175 is close to the median of 163 across 30 interventional studies indexed under Pelvic Inflammatory Disease.
Browse Pelvic Inflammatory Disease studies →Shanghai University of Traditional Chinese Medicine is the lead sponsor of 99 studies on the registry; 19 are open to participants now.
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Exclusion Criteria:
The intervention is Comprehensive treatment of TCM,which including Oral medicine ,tradition chinese medicine enema, external treatment.
Drug: Comprehensive treatment of TCM
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.）
Other: Expectant 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.
Also known as: Oral medicine and TCM 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.）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.
Also known as: Do not give any treatment
changes of The Symptom score
Patients are checked The Symptom score at 3 months after treatment.
Time frame: 3 months after treatment
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
Plan to share: No
No publications or documents are linked to this record.
This study is status unknown, as verified in Oct 2016. You cannot join it, but the record below documents what was studied.
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Shanghai University of Traditional Chinese Medicine