Medical Chitosan or Sodium Hyaluronate for Knee Osteoarthritis (CHOOSE)
NCT ID: NCT02323451
Last Updated: 2014-12-24
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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UNKNOWN
PHASE4
270 participants
INTERVENTIONAL
2014-12-31
2017-04-30
Brief Summary
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Detailed Description
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Conditions
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
DOUBLE
Study Groups
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Medical Chitosan
Medical Chitosan, 2ml/vial (12mg/ml), intra-articular injection with a volume less than 2ml every two weeks, a total of 3 times
Medical Chitosan
intra-articular injection
Sodium Hyaluronate Injection
Sodium Hyaluronate Injection, 2ml/vial (10mg/ml), intra-articular injection with a volume less than 2ml every one weeks, a total of 5 times.
Sodium Hyaluronate Injection
intra-articular injection
Interventions
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Medical Chitosan
intra-articular injection
Sodium Hyaluronate Injection
intra-articular injection
Eligibility Criteria
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Inclusion Criteria
2. Conforming to the diagnosis standard of the American College of Rheumatology in 2009： knee pain and osteophyte determined with X-ray, and at least one of the following items：
* above 50 years old
* morning stiffness less than 30 minutes
* knee joint with fricative when moving
3. The studying knee has score of 40-90 mm on a 100 mm measured VAS and the other side was less than 40mm when walking on flat ground.
4. The studying knee has score of 1, 2 or 3 determined by radiological Kellgren-Lawrence grading scale.
5. Patients who have treatment requirements and can obey the therapeutic schedule
6. Body mass index(BMI) ≤35kg/m2。
7. Able to follow the clinical observation and follow up.
8. The subjects are able to understand and sign the informed consent after fully understand this study, the disease, investigational drugs, the therapeutic schedule and the potential risks.
Exclusion Criteria
2. Other inflammatory pain diseases of knee joint, such as rheumatism/ rheumatoid arthritis, psoriatic arthritis, gout, hemophilic arthritis, etc.
3. Pain diseases of knee joint, except for osteoarthritis, such as intra-articular tumor, villonodular synovitis, joint trauma, etc.
4. Pregnant or lactating females.
5. Participants who suffer from serious cardiovascular disease (Sudden cerebral infarction with sequela or myocardial infarction within recent 6 months), hepatic disease, kidney disease；Participants whose ALT and AST are twice or more than twice than that of the upper limit of normal value；Participants whose serum creatinine exceed the upper limit of normal value；Participants who suffer from dysfunction of blood coagulation (thrombocytopenia, bleeder disease, etc.)
6. Participants who have systemic infection or infectious disease.
7. Participants who suffer from serious skin defect or ulcer around the studying knee joint.
8. Participants who suffer from typical varus or valgus deformities or lack of articular cavity.
9. Participants with diabetes and have to inject insulin or who are not good enough to control the blood glucose (FBG ( fasting blood-glucose) ≥10mmol/L.)
10. Participants who suffer from cancer (within 5 years) or Alzheimer's disease.
11. Participants with score 0 or 4 of the studying knee joint evaluated by radiological Kellgren-Lawrence grading scale.
12. Participants who have hormone drugs within 2 weeks or analgesic drugs within 1 week before this trial or take part in other clinical trials.
13. Participants whose studying knee receives articular cavity therapy within 3 months, containing intra articular administration, articular irrigation and arthroscopic surgery
14. Participants with an allergy to the experimental drugs.
15. Participants who are not suitable for this trial judged by the researchers.
40 Years
75 Years
ALL
No
Sponsors
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Shanghai Qisheng Biological Preparation Co., Ltd.
INDUSTRY
Responsible Party
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Principal Investigators
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Changqing Zhang, PhD
Role: PRINCIPAL_INVESTIGATOR
Shanghai,China.Shanghai Sixth People's Hospital. Orthopedics. Recruiting. No. 600. Yishan Rd. Shanghai. Post Code:200233.
Shigui Yan, PhD
Role: PRINCIPAL_INVESTIGATOR
Hangzhou,Chian. The Second Affiliated Hospital of Zhejiang University School of Medicine. Orthopedics. Not yet recruiting. No.88 Jiefang Road Hangzhou.China Post Code：310009
Locations
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Shanghai Sixth People's Hospital. Orthopedics.
Shanghai, Shanghai Municipality, China
Countries
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Central Contacts
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Facility Contacts
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Changqing Zhang, PhD
Role: primary
Shengbao Chen, MD
Role: backup
Other Identifiers
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QS20140506
Identifier Type: -
Identifier Source: org_study_id