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Financial Reasons
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| Name | Class |
|---|---|
| LeraPharm Inc. | INDUSTRY |
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The purpose of the study was designed to evaluate the efficacy and safety of Soulera herbal mix in powder form and its effects on anxiety and the biomarkers for chronic stress.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Soulera Herbal Blend | Experimental |
| |
| Placebo Blend | Placebo Comparator |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Soulera Herbal Blend | Dietary Supplement | This a powder blend of various reputed adaptogenic herbs. The dosage will be one 8.6 gram powder sachet daily. |
|
| Measure | Description | Time Frame |
|---|---|---|
| Salivary Cortisol Levels | Change in salivary cortisol as stress biomarkers for the chronic stress response following Soulera Herbal Blend intake | 14 Weeks |
| Measure | Description | Time Frame |
|---|---|---|
| Change in chronic stress | The State-Trait Anxiety Test will be given to measure the change in both chronic stress and anxiety.( | 6 times during 14 weeks |
| Quality of Life Questionaire | A survery to measure your quality of life. |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Joseph V Pergolizzi, Jr., M.D. | NEMA Research, Inc. | Principal Investigator |
| Robert Taylor Jr., Ph.D. | NEMA Research, Inc. | Principal Investigator |
| Ismail Shalaby, M.D., Ph.D. | NEMA Research, Inc. | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| NEMA Research, Inc. | Naples | Florida | 34108 | United States |
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| Label | URL |
|---|---|
| Related Info | View source |
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| Placebo | Dietary Supplement | The placebo will be a similar tasting and looking powder blend as the Soulera Herbal Blend. The dosage will be 8.6 grams per sachet daily. |
|
| 6 times during 14 weeks |
| Spot Urine Potassium Test | A spot urine test will be conducted to determine potassium level. Only the potassium will be measured in the urine. | 6 times during 14 weeks |