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
Who can join
As published by the study on ClinicalTrials.gov. "Not stated" means the study hasn't said — ask the study team.
- Age
- 18 Years and older
- Sex
- All sexes
- Healthy volunteers
- Not accepted
- Compensation
- Not stated
Other requirements are listed under Eligibility below. Only the study team can confirm whether you can join.
What to expect
No one can promise a trial will help you personally — that is what the research is trying to find out.
What participation involves
- Time periods mentioned: 3 months
- Procedures mentioned: Questionnaires, Blood draws
Only what the study's summary and detailed description on ClinicalTrials.gov say. Time periods may describe the whole study or a part of it — ask the study team what applies to you.
Show the study's own words
- "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."
- Compensation
- Not stated
- Study-related exams and procedures are typically provided at no cost. This is how many trials work in general — confirm the details for this study with the study team.
- Participants are monitored closely by the research team throughout the study.
- Some participants may receive access to an investigational treatment, which is still being studied.
- Your participation helps researchers learn whether this approach could help future patients.
About this study
In plain language
This study tests whether Viv, a supplement made from the magnolia plant, changes blood proteins linked to immune activity in adults with psoriasis. Participants take Viv or a placebo, a look-alike with no drug, daily for 3 months. They also fill out online surveys and collect blood samples at home.
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.
Compensation is read from the study's own description and may be missing — always confirm with the study team.
Eligibility
Who can join
- Be age 18 or older when you agree to join.
- Have stable psoriasis for at least 6 months, confirmed by a skin doctor.
- Related health problems, including joint swelling from psoriatic arthritis, are allowed if they do not need the whole-body treatments listed below.
- Be able to read and understand English.
- Be able to understand the study and give consent to join.
- Be able to use your own smartphone and download the Chloe by People Science app.
- Have a United States address where the study product can be shipped.
- Be able to follow study steps, including collecting and shipping blood samples.
Who can't join
- Do not have your own smartphone or internet access, or will not download Chloe.
- Used non-biologic drugs that lower immune activity throughout the body, such as methotrexate, within 8 weeks before study group assignment.
- Used biologic treatments, drugs made from living cells that act throughout the body, within 6 months before study group assignment.
- Used other experimental drugs that act throughout the body within 6 months before study group assignment.
- Are pregnant, plan to become pregnant in the next 3 months, or are breastfeeding.
- Have a health problem that could affect the review of digestive symptoms, study results, or your ability to take part.
- Have a known allergy or past allergic reaction to magnolia, rice, or hypromellose.
- Are unlikely to follow study steps, or the lead study doctor decides the study is not suitable for you.
Simplified for readability. The official criteria below are what the study team uses.
Official eligibility criteria
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 sites (1)
NJ
- Decentralized Study Coordinating Center · Englewood, NJ 07631Viv Clinical Trial Operations · Study contact · clinicaltrial@takeviv.comMore trials in Englewood