NCT07471048招募中不适用
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
Sirt3 LLC1 个研究点 分布在 1 个国家目标入组 100 人开始时间: 2026年3月1日最近更新:
干预措施
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 发起方
- 入组人数
- 100
- 试验地点
- 1
- 主要终点
- Relative change in plasma Beta defensin 2 from baseline
研究概览
简要总结
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.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Basic Science
- 盲法
- Triple (Participant, Investigator, Outcomes Assessor)
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •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
排除标准
- •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.
研究组 & 干预措施
Viv
Experimental
Magnolia officinalis study arm
干预措施: Oral supplement containing 200mg Magnolia officinalis bark extract (Dietary Supplement)
Placebo
Placebo Comparator
Placebo control study arm
干预措施: Placebo (Dietary Supplement)
结局指标
主要结局
Relative change in plasma Beta defensin 2 from baseline
时间窗: 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
次要结局
- Exploratory analyses of serum proteomics(Baseline to end of study product/placebo use at 12 weeks)
- Exploratory analysis of circulating immune cells(Baseline to end of study product/placebo use at 12 weeks)
- Quality of life assessment(Baseline to end of study product/placebo use at 12 weeks)
- Self reported psoriasis symptoms(Baseline to end of study product/placebo use at 12 weeks)
研究者
Adeeb Rahman
Head of Translational Research
Sirt3 LLC
研究点 (1)
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