Radicle GI HealthTM VNB: A Study Assessing the Impact of Health and Wellness Products on Constipation and Related Health Outcomes
Radicle GI HealthTM VNB: A Randomized, Double-Blind, Placebo- Controlled Direct-to-Consumer Study Assessing the Impact of Health and Wellness Products on Constipation and Related Health Outcomes
調査の概要
詳細な説明
This is a randomized, double-blind, placebo-controlled study conducted with adult participants, residing in the United States. Eligible participants will (1) have the opportunity for meaningful improvement (at least 30%) in their primary health outcome, and (2) express acceptance in taking a product and not knowing its formulation until the end of the study.
Participants that report a known contraindication or with well-established, significant safety concerns due to illness will be excluded. Heavy drinkers and those who report they are pregnant, trying to become pregnant, or breastfeeding will be excluded. Participants that report taking medications with a known contraindication or with well-established, significant safety concerns will be excluded. Self-reported data are collected electronically from eligible participants for 5 weeks. Participant reports of health indicators will be collected at enrollment and throughout the active period of study product usage. All study assessments will be electronic; there are no in-person visits or assessments for this real-world evidence study.
研究の種類
入学 (推定)
段階
- 適用できない
連絡先と場所
研究連絡先
- 名前：Study Manager
- 電話番号：858-779-0086
- メール：studymgmt@radiclescience.com
研究連絡先のバックアップ
- 名前：Susan Hewlings
- 電話番号：760-281-3898
- メール：susan.hewlings@radiclescience.com
研究場所
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California
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Del Mar、California、アメリカ、92014-2605
- 募集
- Radicle Science Inc.
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コンタクト：
- Study Manager
- 電話番号：760-281-3898
- メール：studymgmt@radiclescience.com
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コンタクト：
- Megan Moseley
- メール：megan@radiclescience.com
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-
参加基準
適格基準
就学可能な年齢
- 大人
- 高齢者
健康ボランティアの受け入れ
説明
3.1 Inclusion
Participants must meet all the following criteria:
Adults, at least 21 years of age at the time of electronic consent, inclusive of all ethnicities, races, and gender identities
- Assigned sex at birth will determine sex-specific recruitment and PROs (male vs female) employed, when needed
- Resides in the United States
- Has the opportunity for at least 30% improvement in their primary health outcome
- Expresses a willingness to take a study product and not know the product identity (active or placebo) until the end of the study
3.2 Exclusion
Individuals who report any of the following during screening may be excluded from participation:
- Report being pregnant, trying to become pregnant, or breastfeeding
- Unable to provide a valid US shipping address and mobile phone number
- Reports current enrollment in another clinical trial
- Reports being a heavy drinker (defined as drinking 3 or more alcoholic beverages per day)
- Unable to read and understand English at a 7th grade level
- Reports a current and/or recent (up to 3 months ago) major illness and/or surgery that poses a known, significant safety risk.
Reports a diagnosis of cardiac dysfunction, liver or kidney disease that presents a known contraindication and/or a significant safety risk with any of the study product ingredients.
- NYHA Class III or IV congestive heart failure, atrial fibrillation, uncontrolled arrhythmias, cirrhosis, end-stage liver disease, stage 3b or 4 chronic kidney disease, or kidney failure
Reports taking medications that have a well-established moderate or severe interaction, posing a substantial safety risk with any of the study product ingredients.
- Anticoagulants, antihypertensives, anxiolytics, antidepressants, chemotherapy, immunotherapy, sedative hypnotics, seizure medications, medications that warn against grapefruit consumption, corticosteroids at doses greater than 5 mg per day, diabetic medications, oral anti-infectives (antibiotics, antifungals, antivirals) to treat an acute infection, antipsychotics, MAOIs, or thyroid products
Reports current use of the primary ingredient(s) and/or similar product(s) to the active study product(s) that may limit the effects of the study products and/or pose a safety risk
- Reports taking any product for acute constipation
- Reports taking any medications containing levodopa
- Lack of reliable daily access to the internet
研究計画
研究はどのように設計されていますか？
デザインの詳細
- 主な目的：他の
- 割り当て：ランダム化
- 介入モデル：並列代入
- マスキング：ダブル
武器と介入
参加者グループ / アーム |
介入・治療 |
|---|---|
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実験的：Active GI Health Product 1
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Participants will use their Active GI Health Product as directed for a period of 4 weeks
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プラセボコンパレーター：Placebo GI Health Control
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Participants will use their Placebo GI Health Control product as directed for a period of 4 weeks
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この研究は何を測定していますか？
主要な結果の測定
結果測定 |
メジャーの説明 |
時間枠 |
|---|---|---|
|
Change in Constipation
時間枠：5 weeks
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Change in Constipation: Difference between rates of change over time in constipation score as assessed by PROMIS Constipation 9A (scale 5-45; where the higher scores correspond to worse constipation)
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5 weeks
|
二次結果の測定
結果測定 |
メジャーの説明 |
時間枠 |
|---|---|---|
|
Change in Gas and Bloating
時間枠：5 weeks
|
Change in Gas and Bloating: Difference between rates of change over time in gas and bloating score as assessed by PROMIS Gas and Bloating 13A (scale 3-59; where the higher scores correspond to worse gas and bloating)
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5 weeks
|
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Change in GI-related Quality of Life (QOL)
時間枠：5 weeks
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Change in GI-related Quality of Life (QOL): Difference between rates of change over time in GI-related QOL as assessed by Digestion-associated Quality of Life Questionnaire (scale 0-9; where the higher scores correspond to worse GI-related quality of life)
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5 weeks
|
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Change in the severity of gastrointestinal symptoms
時間枠：5 weeks
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Change in the severity of gastrointestinal symptoms: Difference between rates of change over time in gastrointestinal symptoms score as assessed by GSRS (scale 7-105; with higher scores equaling greater severity)
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5 weeks
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その他の成果指標
結果測定 |
メジャーの説明 |
時間枠 |
|---|---|---|
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Minimal clinically important difference (MCID) in Constipation
時間枠：5 weeks
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Minimal clinically important difference (MCID) in Constipation: Likelihood of experiencing minimal clinically important difference in constipation, as measured by PROMIS Constipation 9A (scale 5-45; where the higher scores correspond to worse constipation)
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5 weeks
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Minimal clinically important difference (MCID) in Gas and Bloating
時間枠：5 weeks
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Minimal clinically important difference (MCID) in Gas and Bloating: Likelihood of experiencing minimal clinically important difference in gas and bloating, as measured by PROMIS Gas and Bloating 13A (scale 3-59; where the higher scores correspond to worse gas and bloating)
|
5 weeks
|
|
Minimal clinically important difference (MCID) in GI-related Quality of Life (QOL)
時間枠：5 weeks
|
Minimal clinically important difference (MCID) in GI-related Quality of Life (QOL): Likelihood of experiencing minimal clinically important difference in GI-related QOL as assessed by Digestion-associated Quality of Life Questionnaire (scale 0-9; where the higher scores correspond to worse GI-related quality of life)
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5 weeks
|
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Change in Diarrhea
時間枠：5 weeks
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Change in Diarrhea: Difference between rates of change over time in diarrhea score as assessed by PROMIS Diarrhea 6A (scale 2-30; where the higher scores correspond to worse diarrhea)
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5 weeks
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Minimal clinically important difference (MCID) in Diarrhea
時間枠：5 weeks
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Minimal clinically important difference (MCID) in Diarrhea: Likelihood of experiencing minimal clinically important difference in diarrhea, as measured by PROMIS Diarrhea 6A scale (2-30; where the higher scores correspond to worse diarrhea)
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5 weeks
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Change in cognitive function
時間枠：5 weeks
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Change in cognitive function: Difference in rates of change over time in cognitive function score as assessed by PROMIS Cognitive Function 4A (scale 4-20; where lower scores correspond to worse cognitive function)
|
5 weeks
|
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Minimal clinically important difference (MCID) in cognitive function
時間枠：5 weeks
|
Minimal clinically important difference (MCID) in cognitive function: Likelihood of experiencing minimal clinically important difference in cognitive function score as assessed by PROMIS Cognitive Function 4A (scale 4-20; where lower scores correspond to worse cognitive function)
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5 weeks
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Minimal clinically important difference (MCID) in the severity of gastrointestinal symptoms
時間枠：5 weeks
|
Minimal clinically important difference (MCID) in the severity of gastrointestinal symptoms: Likelihood of experiencing minimal clinically important difference in gastrointestinal symptoms score as assessed by GSRS (scale 7-105; with higher scores equaling greater severity)
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5 weeks
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協力者と研究者
スポンサー
捜査官
- 主任研究者：Susan Hewlings、Radicle Science
出版物と役立つリンク
便利なリンク
研究記録日
主要日程の研究
研究開始 (実際)
一次修了 (推定)
研究の完了 (推定)
試験登録日
最初に提出
QC基準を満たした最初の提出物
最初の投稿 (実際)
学習記録の更新
投稿された最後の更新 (実際)
QC基準を満たした最後の更新が送信されました
最終確認日
詳しくは
本研究に関する用語
追加の関連 MeSH 用語
その他の研究ID番号
- RADX_P_2604_VNB
個々の参加者データ (IPD) の計画
個々の参加者データ (IPD) を共有する予定はありますか?
IPD プランの説明
医薬品およびデバイス情報、研究文書
米国FDA規制医薬品の研究
米国FDA規制機器製品の研究
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