A Study to Evaluate the Impact of a Magnolia Officinalis Dietary Supplement on Immune Biomarkers in Subjects With Psoriasis

Официальное название

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

Обзор

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.

Вмешательства

• Пищевая добавка Oral supplement containing 200mg Magnolia officinalis bark extract
  Viv is a consumer grade oral supplement containing 200mg Magnolia officinalis bark extract encapsulated in a hypromellose capsule.
• Пищевая добавка Placebo
  Oral hypromellose capsule with all inactive ingredients but lacking the Magnolia officinalis bark extract

Первичные конечные точки

• Relative change in plasma Beta defensin 2 from baseline [Срок оценки: From baseline to the end of study product/placebo use at 12 weeks]

Вторичные конечные точки (4)

• Exploratory analyses of serum proteomics [Срок оценки: Baseline to end of study product/placebo use at 12 weeks]
• Exploratory analysis of circulating immune cells [Срок оценки: Baseline to end of study product/placebo use at 12 weeks]
• Quality of life assessment [Срок оценки: Baseline to end of study product/placebo use at 12 weeks]
• Self reported psoriasis symptoms [Срок оценки: Baseline to end of study product/placebo use at 12 weeks]

Критерии участия

Критерии включения

• 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)

Критерии исключения

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.

Критерии приведены из реестра в оригинале (на английском). Окончательную оценку соответствия проводит исследовательский центр.

Здоровые добровольцы: Нет

Дизайн исследования

Распределение

Рандомизированное

Модель

Параллельные группы

Маскирование

Тройное слепое

Основная цель

Фундаментальное исследование

Центры проведения

США · 1 центр

• Decentralized Study Coordinating Center — Englewood

Идентификаторы

NCT: NCT07471048 · PS21-14773

Первоисточники (государственные реестры)

• ClinicalTrials.gov (NIH, США)

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