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TCM Complex Treatment for Pelvic Inflammatory Disease Sequelae
NCT02972151Phase 2
Key facts
- Status
- Unknown
- Start
- Nov 2016
- Primary completion
- Dec 2018
- Countries
- 1
- Sponsor
- Shanghai University of Traditional Chinese Medicine
- Modality
- HMF (Herbal Medicine Formulation)
- Drugs
- bazhengsan
- Conditions
- pelvic inflammatory disease (PID)
01
Overview
Phase 2, randomised, open-label trial of bazhengsan in pelvic inflammatory disease (PID) (2 arms), sponsored by Shanghai University of Traditional Chinese Medicine. Primary endpoint: Changes of The Symptom score. Status: unknown.
02
Design
2 arms- Study design
- RandomizedOpen-label
Comprehensive treatment of TCM
Oral medicine + TCM enema + External application
Expectant therapy
No treatment
03
Who it enrols
Adult female patients aged 18-60 with a diagnosis of sequelae of pelvic inflammatory disease (Western and TCM criteria), married or sexually active. Excludes acute PID, gynecological tumors, specific vaginitis, endometriosis, tuberculosis, severe primary diseases, and allergies.
04
Endpoints
Primary
Changes of The Symptom score
Secondary
Changes of The Hamilton Depression Scale
Changes of The Sign score sheet
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