- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT07471048
A Study to Evaluate the Impact of a Magnolia Officinalis Dietary Supplement on Immune Biomarkers in Subjects With Psoriasis
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
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.
Study Overview
Status
Conditions
Study Type
Enrollment (Estimated)
Phase
- Not Applicable
Contacts and Locations
Study Contact
- Name: Adeeb Rahman, PhD
- Phone Number: 2013596845
- Email: clinicaltrial@takeviv.com
Study Locations
-
-
New Jersey
-
Englewood, New Jersey, United States, 07631
- Recruiting
- Decentralized Study Coordinating Center
-
Contact:
- Viv Clinical Trial Operations
- Email: clinicaltrial@takeviv.com
-
-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
- Adult
- Older Adult
Accepts Healthy Volunteers
Description
Inclusion Criteria:
- Male of female, aged 18 years or older at time of consent.
- Diagnosis of stable psoriasis affecting for at least 6 months confirmed by a dermatologist.
- Patients with psoriasis-associated comorbidities including psoriatic arthritis are permitted, as long as those comorbidities are not severe enough to require treatment with systemic therapies as defined in the exclusion criteria.
- Able to read and understand English.
- Able to read, understand, and provide informed consent.
- Able to use a personal smartphone device and download Chloe by People Science.
- Able to receive shipment of the product at an address within the United States.
- Able to adhere to study protocol (e.g., willing to collect and ship blood samples)
Exclusion Criteria:
Any potential participants who:
- Do not have a personal smartphone, internet access, or unwilling to download Chloe.
- Prior treatment with any systemic non-biologic immunosuppressive agents (e.g., methotrexate, cyclosporine, azathioprine) within 8 weeks prior to randomization.
- Prior treatment with any systemic biologic therapies (e.g., guselkumab, risankizumab, ustekinumab, secukinumab, brodalumab, infliximab, adalimumab, golimumab, etanercept) within 6 months prior to randomization
- Prior treatment with any other systemic investigational drugs within 6 months prior to randomization.
- Other Illnesses or Conditions: Participants who have the following comorbidities or gastrointestinal illnesses are excluded:
- Currently pregnant, planning to become pregnant in the next 3 months, or breastfeeding
- Any underlying medical conditions or comorbidities that may confound the assessment of digestive symptoms or the evaluation of the study outcomes.
- Have a significant illness, disease or condition which, in the opinion of the principal investigator, may impact their ability to participate in the study or impact the study outcomes.
- Known hypersensitivity or previous allergic reaction to magnolia, rice or hypromellose.
- Are unlikely for any reason to be able to comply with the trial or considered unsuited for participation in the study by the Principal Investigator.
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Basic Science
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: Triple
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
|---|---|
|
Experimental: Viv
Magnolia officinalis study arm
|
Viv is a consumer grade oral supplement containing 200mg Magnolia officinalis bark extract encapsulated in a hypromellose capsule.
|
|
Placebo Comparator: Placebo
Placebo control study arm
|
Oral hypromellose capsule with all inactive ingredients but lacking the Magnolia officinalis bark extract
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Relative change in plasma Beta defensin 2 from baseline
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
|
From baseline to the end of study product/placebo use at 12 weeks
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Exploratory analyses of serum proteomics
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
|
Baseline to end of study product/placebo use at 12 weeks
|
|
Exploratory analysis of circulating immune cells
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
|
Baseline to end of study product/placebo use at 12 weeks
|
|
Quality of life assessment
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)
|
Baseline to end of study product/placebo use at 12 weeks
|
|
Self reported psoriasis symptoms
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)
|
Baseline to end of study product/placebo use at 12 weeks
|
Collaborators and Investigators
Sponsor
Collaborators
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Estimated)
Study Completion (Estimated)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- PS21-14773
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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