Magnolia officinalis (Viv) supplement for immune biomarkers in adults 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
This study will test whether taking the Viv Magnolia officinalis supplement daily for three months changes immune-related blood markers in adults with stable psoriasis compared to a placebo.
Quick facts
| Phase | Not applicable |
|---|---|
| Study type | Interventional |
| Enrollment | 100 (estimated) |
| Ages | 18 Years and up |
| Sex | All |
| Sponsor | Sirt3 LLC Industry-sponsored |
| Drugs / interventions | guselkumab, risankizumab, ustekinumab, secukinumab, brodalumab, infliximab, adalimumab, golimumab, methotrexate |
| Locations | 1 site (Englewood, New Jersey) |
| Trial ID | NCT07471048 on ClinicalTrials.gov |
What this trial studies
This decentralized interventional trial gives adults with psoriasis either the Viv dietary supplement (200 mg Magnolia officinalis bark extract) or a matching placebo to take daily for three months. Participants complete electronic quality-of-life and symptom questionnaires at baseline, 1 month, and 3 months and use at-home blood collection kits at the same time points. Researchers will analyze the blood samples to measure levels of specific inflammatory proteins and compare how these immune biomarkers change over time between the Viv and placebo groups. Enrollment is limited to adults in the United States who can use the study app and receive shipped kits and products.
Who should consider this trial
Good fit: Adults aged 18 or older with dermatologist-confirmed stable psoriasis for at least six months who are not on systemic immunosuppressive therapy, can use a smartphone app, and can receive shipments in the United States.
Not a fit: People who require systemic immunosuppressive treatments, lack a personal smartphone or internet access, cannot receive shipments in the U.S., or have severe comorbidities are unlikely to be eligible or to benefit from this study.
Why it matters
Potential benefit: If Viv lowers inflammatory biomarkers, it could offer a low-risk supplement option to reduce immune activity linked to psoriasis and potentially improve symptoms.
How similar studies have performed: This approach is relatively novel for psoriasis: preclinical data and small human supplement studies suggest anti-inflammatory effects of Magnolia extracts, but robust clinical trial evidence in psoriasis is limited.
Eligibility criteria
Show full inclusion / exclusion 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.
Where this trial is running
Englewood, New Jersey
- Decentralized Study Coordinating Center — Englewood, New Jersey, United States (Recruiting)
Study contacts
- Study coordinator: Adeeb Rahman, PhD
- Email: clinicaltrial@takeviv.com
- Phone: 2013596845
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.