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| Name | Class |
|---|---|
| Joint Health Wellness Group, LLC. | INDUSTRY |
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The primary objective of the study is to assess the effectiveness of alpha-D Glucosamine Sulfate/Standardized Extract of Ginkgo Biloba Leaf versus a comparator product on osteoarthritis pain as assessed by the between group change in WOMACâ„¢ Osteoarthritis Index Pain Subscale using Visual Analogue Scale (VAS) scores in subjects with osteoarthritis of the knee.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Glucosamine Sulfate Potassium Chloride/Ginkgo Biloba Extract | Experimental | 2 capsules daily, immediately following a meal. 1 capsule in the morning, and 1 capsule in the evening, at approximately the same time each day. |
|
| Placebo | Placebo Comparator | 2 capsules daily, immediately following a meal. 1 capsule in the morning, and 1 capsule in the evening, at approximately the same time each day. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Glucosamine Sulfate Potassium Chloride/Standardized Ginkgo Biloba Extract | Dietary Supplement |
| ||
| Measure | Description | Time Frame |
|---|---|---|
| WOMACâ„¢ Osteoarthritis Index Pain Subscale as a measure of Osteoarthritis pain | Assessed at screening and every visit. | 12 weeks |
| Measure | Description | Time Frame |
|---|---|---|
| WOMACâ„¢ Osteoarthritis Index Pain Subscale as a measure of Osteoarthritis pain | Measured at screening and every visit. Within group changes assessed | 12 weeks |
| WOMACâ„¢ Osteoarthritis Index Total Score as a measure of Osteoarthritis |
| Measure | Description | Time Frame |
|---|---|---|
| Safety Blood Panel | Over 12 weeks | |
| Blood Pressure | Over 12 weeks | |
| Heart Rate |
Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Tetyana Pelipyagina, MD | KGK Science Inc. | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| KGK Synergize Inc. | London | Ontario | N6A 5R8 | Canada |
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| Placebo |
| Other |
|
Measured at screening and every visit
| 12 weeks |
| WOMACâ„¢ Osteoarthritis Index Stiffness Score as a measure of Osteoarthritis stiffness | Measured at screening and every visit | 12 weeks |
| WOMACâ„¢ Osteoarthritis Index Physical Fuction Score as a measure of Osteoarthritis Physical Function | Measured at screening and every visit | 12 weeks |
| Rand SF-36 questionnaire score as a measure of Quality of Life | Measured at every visit | 12 weeks |
| Cartilage Oligomeric Matrix Protein (COMP) | 12 weeks |
| IL-1 Beta | 12 weeks |
| Amount of rescue medication used | 12 weeks |
| Over 12 weeks |
| BMI | Over 12 weeks |
| Incidence of Adverse Events | Over 12 weeks |
| ID | Term |
|---|---|
| D020370 | Osteoarthritis, Knee |
| D010003 | Osteoarthritis |
| ID | Term |
|---|---|
| D001168 | Arthritis |
| D007592 | Joint Diseases |
| D009140 | Musculoskeletal Diseases |
| D012216 | Rheumatic Diseases |
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