Decentralized Study Coordinating Center
Englewood, New Jersey, 07631, United States
Location status: Recruiting
NCT Number: NCT07471048
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:
* Take Viv or a placebo every day for 3 months. * Complete electronic questionnaires about their quality of life and psoriasis symptoms at the beginning of the study and again at 1 months and 3 months. * Be provided with at home blood collection kits, which they will use to collect blood at the beginning of the study and again at 1 months and 3 months.
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.
Interested in participating?
Request Info18 year and older
All sexes
Interventional
Not applicable
Englewood, New Jersey, 07631, United States
Location status: Recruiting
Healthy volunteers accepted: No
Only the study team can determine whether someone qualifies for participation.
Inclusion criteria
Exclusion criteria
Any potential participants who:
Viv is a consumer grade oral supplement containing 200mg Magnolia officinalis bark extract encapsulated in a hypromellose capsule.
Oral hypromellose capsule with all inactive ingredients but lacking the Magnolia officinalis bark extract
Time frame: From baseline to the end of study product/placebo use at 12 weeks
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
Time frame: Baseline to end of study product/placebo use at 12 weeks
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
Time frame: Baseline to end of study product/placebo use at 12 weeks
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
Time frame: Baseline to end of study product/placebo use at 12 weeks
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)
Time frame: Baseline to end of study product/placebo use at 12 weeks
Change in self-reported psoriasis symptoms between placebo and study group at 12 weeks relative to baseline as measured by Psoriasis Symptom Scale (PSS)
Contact information is provided by the study sponsor or research team.
Sirt3 LLC
Industry
A Decentralized, Randomized Interventional Study to Evaluate the Impact of an Over-the-Counter Magnolia Officinalis Oral Supplement on Blood Biomarkers of Immune Activation in Subjects With Psoriasis
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View the official ClinicalTrials.gov record (opens in a new tab)This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.
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