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The purpose of this study will be to show the patient response to analgesics taken post surgery when taken in combination with Theramine as opposed to Theramine-like placebo. The data collected will be used to show that patients have a shorter and lower post operative pain measurement and the time to discontinuation of analgesics is less in the active comparator group.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Theramine | Active Comparator | Theramine 2 capsules three times per day in addition to post surgical analgesic medication. |
|
| Theramine-like Placebo | Placebo Comparator | Theramine-like placebo 2 capsules three times per day in addition to post surgical analgesic medication. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Theramine | Drug | Theramine 2 capsules 3 times per day |
| |
| Theramine- like placebo |
| Measure | Description | Time Frame |
|---|---|---|
| Dose reduction of analgesic. | The primary efficacy outcome will be the overall dose reduction of analgesic in the Theramine active group versus the Theramine placebo group. | 28 days |
| Measure | Description | Time Frame |
|---|---|---|
| Change in Visual Analogue Scale Evaluation (VASE) | 28 days | |
| Change in second Knee pain scale. | 28 Days | |
| Time to discontinuation of analgesic. |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Gregory V. Hickman, MD | Andrews-Paulos Research & Education Institute | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Andrews-Paulos Research & Education Institute | Gulf Breeze | Florida | 32561 | United States |
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| Label | URL |
|---|---|
| Related Info | View source |
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Too small data set to draw any conclusions
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| Drug |
Theramine-like placebo capsules 2 three times daily |
|
| 28 days |