Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
This study is designed to evaluate the effectiveness of a proprietary nutritional supplement that contains Krill Oil (KO), astaxanthin (AX) and hyaluronic acid (HA) to reduce pain and discomfort in participants, compared to an inert placebo (palm oil) control and to a positive control (glucosamine-chondroitin). The purpose of the study is to determine if the combination of KO, AX, and HA will benefit participants with joint pain.
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Joint Health Product | Experimental |
| |
| Placebo | Placebo Comparator |
| |
| Glucosamine / Chondroitin | Active Comparator |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Joint Health Product | Dietary Supplement | Krill oil, Astaxanthin, Hyaluronic Acid Formulation, 353 mg per day; Softgel capsule |
|
| Measure | Description | Time Frame |
|---|---|---|
| WOMAC Change | Change in Clinical Coordinator administered pain assessment and pain intensity evaluation over 56 days as determined by the Western Ontario and McMaster Universities Osteoarthritis Index™© (WOMAC) | Days: 0, 14, 28 and 56 |
| VAS Change | Change in Self-administered Visual Analogue Pain Assessment and Pain Intensity Rating Scale (VAS) over 56 days | Days: 0, 7, 14, 28, 35, 42 and 56 |
| Measure | Description | Time Frame |
|---|---|---|
| Blood Chemistry CBC Change | Change in CBC and differentials over 56 days | Days: 0, 14, 28 and 56 |
| Blood Chemistry hs-CRP Change | Change in hs-CRP over 56 days |
Not provided
Inclusion Criteria:
Exclusion Criteria:
Not provided
Not provided
Not provided
Not provided
Not provided
| Name | Affiliation | Role |
|---|---|---|
| Eshwari Koovor, M.B.B.S. | PI | Principal Investigator |
| Herjit Pannu, MD | PI | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| 1621 Bridgeway | Sausalito | California | 94965 | United States |
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| Placebo | Dietary Supplement | Palm oil Softgel capsule |
|
| Glucosamine / Chondroitin | Dietary Supplement | Glucosamine 1500 mg, Chondroitin 1200 mg per day |
|
| Days: 0, 14, 28 and 56 |
| ID | Term |
|---|---|
| D018771 | Arthralgia |
| ID | Term |
|---|---|
| D007592 | Joint Diseases |
| D009140 | Musculoskeletal Diseases |
| D010146 | Pain |
| D009461 | Neurologic Manifestations |
| D012816 | Signs and Symptoms |
| D013568 | Pathological Conditions, Signs and Symptoms |
Not provided
Not provided
| ID | Term |
|---|---|
| D005944 | Glucosamine |
| D002807 | Chondroitin |
| ID | Term |
|---|---|
| D006595 | Hexosamines |
| D000606 | Amino Sugars |
| D002241 | Carbohydrates |
| D006025 | Glycosaminoglycans |
| D011134 | Polysaccharides |
Not provided
Not provided