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

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.

Study Overview

• Status: Unknown
• Conditions: Pelvic Inflammatory Disease
• Intervention / Treatment: Drug: Comprehensive treatment of TCM; Other: Expectant treatment

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 Type: Interventional
• Enrollment (Anticipated): 175
• Phase: Phase 2

Contacts and Locations

• Study Contact: Name: lianwei xu, Doctor; Phone Number: 64385700-3912; Email: sherryxlw@hotmail.com
• Study Contact Backup: Name: qianjue tang; Phone Number: 64385700-3912

Study Locations

• China
  • Shanghai
    • Shanghai, Shanghai, China
      • Shanghai Longhua Hosptial
      • Contact: lianwei xu, Doctor; Phone Number: 64385700-3912; Email: sherryxlw@hotmail.com
      • Principal Investigator: lianwei xu, Doctor

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 60 years (Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: Female

Description

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 Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Comprehensive treatment of TCM; The intervention is Comprehensive treatment of TCM,which including Oral medicine ,tradition chinese medicine enema, external treatment.	Drug: 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.; Other Names: Oral medicine and TCM enema, external treatment
Active Comparator: 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.）	Other: 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 Names: Do not give any treatment

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
changes of The Symptom score	Patients are checked The Symptom score at 3 months after treatment.	3 months after treatment

Secondary Outcome Measures

Outcome Measure	Time Frame
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

Collaborators and Investigators

• Sponsor: Shanghai University of Traditional Chinese Medicine
• Investigators: Principal Investigator: lianwei xu, Doctor, Shanghai Longhua Hospital

Study record dates

Study Major Dates

• Study Start: November 1, 2016
• Primary Completion (Anticipated): December 1, 2018
• Study Completion (Anticipated): December 1, 2018

Study Registration Dates

• First Submitted: November 17, 2016
• First Submitted That Met QC Criteria: November 21, 2016
• First Posted (Estimate): November 23, 2016

Study Record Updates

• Last Update Posted (Estimate): November 23, 2016
• Last Update Submitted That Met QC Criteria: November 21, 2016
• Last Verified: October 1, 2016

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Infections; Adnexal Diseases; Pelvic Inflammatory Disease; Pelvic Infection
• Other Study ID Numbers: 42501190

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: No