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| Name | Class |
|---|---|
| People Science, Inc. | INDUSTRY |
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The goal of this clinical trial is to evaluate whether Viv, a consumer-grade dietary supplement derived from the Magnolia officinalis plant, has an effect on biomarkers of immune activity in adults with psoriasis. To address this question, this trial will compare Viv to a placebo (a look-alike substance that contains no drug).
Participants will:
Researchers will analyze these blood samples to measure the levels of specific inflammatory proteins and evaluate how they change over the course of the study in the participants taking Viv compared to those taking placebo.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Viv | Experimental | Magnolia officinalis study arm |
|
| Placebo | Placebo Comparator | Placebo control study arm |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Oral supplement containing 200mg Magnolia officinalis bark extract | Dietary Supplement | Viv is a consumer grade oral supplement containing 200mg Magnolia officinalis bark extract encapsulated in a hypromellose capsule. |
| Measure | Description | Time Frame |
|---|---|---|
| Relative change in plasma Beta defensin 2 from baseline | Change in plasma Beta defensin 2 levels between placebo and study product group at 4 weeks and 12 weeks relative to baseline as measured by ELISA | From baseline to the end of study product/placebo use at 12 weeks |
| Measure | Description | Time Frame |
|---|---|---|
| Exploratory analyses of serum proteomics | Change in plasma cytokine levels between placebo and study product groups at 4 weeks and 12 weeks relative to baseline as measured by high throughput plasma proteomics | Baseline to end of study product/placebo use at 12 weeks |
| Exploratory analysis of circulating immune cells |
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Inclusion Criteria:
Exclusion Criteria:
Any potential participants who:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Adeeb Rahman, PhD | Contact | 2013596845 | clinicaltrial@takeviv.com |
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Decentralized Study Coordinating Center | Recruiting | Englewood | New Jersey | 07631 | United States |
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| ID | Term |
|---|---|
| D011565 | Psoriasis |
| ID | Term |
|---|---|
| D017444 | Skin Diseases, Papulosquamous |
| D012871 | Skin Diseases |
| D017437 | Skin and Connective Tissue Diseases |
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| Placebo | Dietary Supplement | Oral hypromellose capsule with all inactive ingredients but lacking the Magnolia officinalis bark extract |
|
Change in proportions and activity of peripheral blood immune cells between placebo and study product groups at 12 weeks relative to baseline as measured by single cell sequencing |
| Baseline to end of study product/placebo use at 12 weeks |
| Quality of life assessment | Change in quality of life between placebo and study product group at 4, and 12 weeks relative to baseline as measured by self-reported Dermatology Life Quality Index (DLQI) | Baseline to end of study product/placebo use at 12 weeks |
| Self reported psoriasis symptoms | Change in self-reported psoriasis symptoms between placebo and study group at 12 weeks relative to baseline as measured by Psoriasis Symptom Scale (PSS) | Baseline to end of study product/placebo use at 12 weeks |