Clinical Research of TCM on Pelvic Inflammatory Disease Sequelae

Phase 2

• Conditions: Pelvic Inflammatory Disease
• Interventions: Drug: Comprehensive treatment of TCM; Other: Expectant treatment

• Registration Number: NCT02972151
• Lead Sponsor: Shanghai University of Traditional Chinese Medicine

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.

Study Timeline

• Status Verified: 2016-10
• Study Start: 2016-11
• Study First Submitted: 2016-11-17
• Study First Submitted QC: 2016-11-21
• Last Update Submitted: 2016-11-21
• Study First Posted: 2016-11-23
• Last Update Posted: 2016-11-23
• Primary Completion: 2018-12
• Study Completion: 2018-12

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: Female
• Target Recruitment: 175

Inclusion Criteria

1. Patients with diagnostic criteria for the sequelae of pelvic inflammatory disease in Western medicine;
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

1. Patients who do not meet the diagnostic criteria of Western medicine and traditional Chinese medicine dialectical typing standard;
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.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Comprehensive treatment of TCM	Comprehensive treatment of TCM	The intervention is Comprehensive treatment of TCM,which including Oral medicine ,tradition chinese medicine enema, external treatment.
Expectant therapy	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.）

Primary Outcome Measures

Name	Time	Method
changes of The Symptom score	3 months after treatment	Patients are checked The Symptom score at 3 months after treatment.

Secondary Outcome Measures

Name	Time	Method
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

Trial Locations

Locations (1)

Shanghai Longhua Hosptial; 🇨🇳 Shanghai, Shanghai, China