Ignite Creation Date:
2025-12-24 @ 11:44 PM
Ignite Modification Date:
2026-02-22 @ 6:47 PM
Study NCT ID:
NCT02323451
Status:
UNKNOWN
Last Update Posted:
2014-12-24
First Post:
2014-12-18
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Medical Chitosan or Sodium Hyaluronate for Knee Osteoarthritis (CHOOSE)
Sponsor:
Shanghai Qisheng Biological Preparation Co., Ltd.
Organization:
Study Overview
Official Title:
A Multicentre, Randomized, Double-blinded, Parallel-controlled, Non-inferiority Clinical Study Of Safety and Efficacy Of Medical Chitosan for Knee Osteoarthritis Compared With Sodium Hyaluronate Injection
Status:
UNKNOWN
Status Verified Date:
2014-12
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:
None
Brief Summary:
This study evaluates the safety and efficacy of investigational products in the treatment of knee Osteoarthritis. Half of participants will receive medical chitosan, while the other half will receive sodium hyaluronate.
Detailed Description:
Medical chitosan and sodium hyaluronate each form the reticular layer to cover the joint surface, alleviate the joint friction and pain. For medical chitosan, its half-life is longer than sodium hyaluronate, so the interval time of intra-articular injection is longer.
Study Oversight
Has Oversight DMC:
True
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?: