Ignite Creation Date:
2025-12-25 @ 2:30 AM
Ignite Modification Date:
2025-12-28 @ 1:28 AM
Study NCT ID:
NCT05133934
Status:
UNKNOWN
Last Update Posted:
2021-11-24
First Post:
2021-08-12
Is Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Traditional Chinese and Western Medicine for Knee Osteoarthritis
Sponsor:
Hong Kong Baptist University
Organization:
Study Overview
Official Title:
Investigation of Traditional Chinese and Western Medicine in the Real World of Knee Osteoarthritis: A Multicenter Cohort Study
Status:
UNKNOWN
Status Verified Date:
2021-11
Last Known Status:
RECRUITING
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
TCMWMKOA
Brief Summary:
A cohort study will be used to collect patient data, analyze the clinical characteristics, traditional Chinese medicine (TCM) syndromes, and treatment of knee osteoarthritis (KOA) in China to accumulate clinical data and clarify the status of KOA in the real world background. It will lay a clinical foundation for further study of KOA in the future, and bring certain clinical value for Chinese patients with KOA.
Detailed Description:
This is a multicenter cohort study. It is planned to carry out multicenter investigation and research on the current situation of knee osteoarthritis in the real world, conduct large-scale investigation on the clinical population of patients with knee osteoarthritis, and establish a research, quality control, data management and statistical analysis platform for the clinical practical application of knee osteoarthritis and hospital registration. This study aims to discover the current clinical characteristics, TCM syndromes, and treatment status of patients with knee osteoarthritis in China, and provide reliable data support for the clinical treatment of KOA. It is estimated that 5000 patients from 23 centers across China will be recruited. Various demographic and disease-related information will be documented, including name, gender, age, job category, disease course, medical consultation experience, treatment satisfaction and so on. Patients will also complete a series of scales, containing Visual Analog Scale (VAS) Score, Knee Injury and Osteoarthritis Outcome Score (KOOS), Western Ontario and McMaster Universities (WOMAC) Osteoarthritis Index, 9-item patient health questionnaire (PHQ-9), SF-12 quality of life, TCM syndrome score sheet, etc. The primary outcome will be the pain (rest pain) VAS, KOOS, WOMAC knee osteoarthritis index score and TCM syndrome score. Secondary outcomes include patient's knee joint function examination, X-ray examination results, blood routine, biochemical indicators and pharmacoeconomic data.
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?: