UMIN ID: UMIN000001027
Registered date:23/02/2008
The effects of collagen and hyaluronic acid for osteoarthritis symptoms study (CHAOS study), OCU-0704
Basic Information
| Recruitment status | Complete: follow-up complete |
|---|---|
| Health condition(s) or Problem(s) studied | Osteoarthritis of the knee |
| Date of first enrollment | 2008/02/01 |
| Target sample size | 100 |
| Countries of recruitment | Japan |
| Study type | Interventional |
| Intervention(s) | Period: 48 weeks Intervention group: the examination food (pigskin extraction collagen peptide 90.2%, hyaluronic acid 0.3%, mucopolysaccharides 0.8%, and water 8.7%) is taken, 5g a day. Control group: Hydrolysate of corn starch (maltodextrin) is taken. 5g a day |
Outcome(s)
| Primary Outcome | WOMAC score, joint narrowing of the knee (MTP view), SF-36, Japanese Orthopaedic Association Back Pain Evaluation Questionnaire (JOABPEQ) |
|---|---|
| Secondary Outcome | Bone metabolic marker (BAP, NTx), cartilage metabolic marker (COMP) |
Key inclusion & exclusion criteria
| Age minimum | 45years-old |
|---|---|
| Age maximum | 80years-old |
| Gender | Male and Female |
| Include criteria | |
| Exclude criteria | artificial replacement of the knees, current use of NSAIDs, current use of steroid, rheumatoid arthritis patients, severe inflammation (ESR>=40mm/h or RF positive), intraarticular injection to the knees within 3 months, abnormal function of liver and kidney (2.5 times or more normal value), intake of alternative medicine (glcosamin, chondroitin sulfate, collagen, and hyaluronic acid) within 4 weeks, remarkable obesity (BMI>30), pregnant or nursing |
Related Information
| Primary Sponsor | Osaka City University Hospital |
|---|---|
| Secondary Sponsor | |
| Source(s) of Monetary Support | Kyusai Co. Ltd. |
| Secondary ID(s) |
Contact
| public contact | |
| Name | Hidekichi Tokai |
| Address | Abenoku Asahimachi 1-2-7, Osaka, 545-8585, Japan Japan |
| Telephone | 06-6645-3440 |
| tokai@med.osaka-cu.ac.jp | |
| Affiliation | Osaka City University Hospital Center for Drug & Food Clinical Evaluation |
| scientific contact | |
| Name | Tatsuya Koike |
| Address | Abenoku Asahimachi 1-4-3, Osaka, 545-8585, Japan Japan |
| Telephone | 06-6645-3984 |
| Affiliation | Osaka City University Medical School Department of Rheumatosurgery |