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| Name | Class |
|---|---|
| Kochan Institute for Healing Arts Research | UNKNOWN |
Study wishes to determine if the use of injectable bee venom is a safe and effective treatment for persons with mild to moderate knee Osteoarthritis and would result in decreased report of pain and discomfort, increased function during daily activities, decrease use of analgesic meds, and improvement in walking and climbing steps. We will be using histamine as a control. 40 subjects will be enrolled in a 3:1 allocation ratio between bee venom and histamine. Each injection of bee venom dosage will consist of 100 micrograms of dried bee venom in 0.1 ml. of 0.5% preservative free Xylocaine. The histamine dosage will consist of .0025 milligrams of histamine in 0.5% preservative free Xylocaine. Subjects will visit the study center for 14 visits over an 18 week span. The clinical hypothesis is that bee venom is an effective treatment for Osteoarthritis and will reduce pain and discomfort, increase range of motion, increase daily function, decrease walking and stair climbing time, and decrease the need of analgesic medication for a period of time beyond treatment (after the study has concluded.) The clinical safety hypothesis is that for persons not allergic to bee venom (patients allergic will not be allowed to enter into the study) the side effects will be small. The most common side effects for bee venom and histamine will be redness and itchiness which will be tolerable and safe.
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Injecting bee venom as a treatment for OA | Procedure |
| Measure | Description | Time Frame |
|---|---|---|
| Change in Visual Analog Scale | ||
| Change in Knee Injury and Osteoarthritis Outcome Score | ||
| Change in use of analgesic meds after 6 weeks of treatment | ||
| Change in 50 ft. walk and 4 step up/down climb time |
| Measure | Description | Time Frame |
|---|---|---|
| Adverse event incidence | ||
| Baseline and visit 12 laboratory assessments | ||
| Change in tenderness and motion |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Boris Ratiner, MD | Medical Director of Rheumatology Therapeutics Medical Center | Principal Investigator |
| Andrew Kochan, MD | Medical Director of Kochan Institute for Healing Arts Research | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Kochan Institute for Healing Arts Research | Recruiting | Encino | California | 91316 | United States |
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| Rheumatology Therapeutics Medical Center | Recruiting | Tarzana | California | 91356 | United States |
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