Radicle Relief 2: A Study of Health and Wellness Products on Pain and Health Outcomes

Pain Clinical Trial

Official title:

Radicle™ Relief 2: A Randomized, Blinded, Placebo-Controlled Direct-to-Consumer Study of Health and Wellness Products on Pain and Other Health Outcomes

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT05837923
• Other study ID #: RADX-2303
• Status: Recruiting
• Phase: N/A
• Start date: March 28, 2024
• Est. completion date: October 2024

Study information

• Verified date: March 2024
• Source: Radicle Science
• Contact: Study Manager
• Phone: 760-281-3898
• Email: studymgmt[@]radiclescience.com
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

A randomized, blinded, placebo-controlled study assessing the impact of health and wellness products on pain and other health outcomes

Description:

This is a randomized, blinded, placebo-controlled study conducted with adult participants, age 21 and older and residing in the United States. Eligible participants will (1) endorse a desire for less pain, (2) indicate an interest in taking a health and wellness product to potentially help their pain, and (3) express acceptance in taking a product and not knowing its formulation until the end of the study. Participants with known liver or kidney disease, heavy drinkers, and those who report they are pregnant, trying to become pregnant, or breastfeeding will be excluded. Those taking certain medications will be excluded. Self-reported data are collected electronically from eligible participants over 7 weeks. Participant reports of health indicators will be collected during baseline, throughout the active period of study product use, and in a final survey. All study assessments will be electronic; there are no in-person visits or assessments for this real-world evidence study.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 3810
• Est. completion date: October 2024
• Est. primary completion date: June 2024
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 21 Years to 105 Years

Eligibility

Inclusion Criteria:

• Adults, 21 years of age and older at the time of electronic consent, inclusive of all ethnicities, races, genders and/or gender identities
• Resides in the United States
• Endorses less pain as a primary desire
• Selects pain and/or looking to improve their pain as a reason for their interest in taking a health and wellness product
• Expresses a willingness to take a study product and not know the product identity (active or placebo) until the end of the study

Exclusion Criteria:

• Reports being pregnant, trying to become pregnant, or breastfeeding
• Unable to provide a valid US shipping address and mobile phone number
• The calculated validated health survey (PRO) score during enrollment represents less than mild severity
• Reports a diagnosis of liver or kidney disease
• Reports being a heavy drinker (defined as drinking 3 or more alcoholic beverages per day)
• Unable to read and understand English
• Reports current enrollment in a clinical trial
• Lack of reliable daily access to the internet
• Reports current or recent (within 3 months) use of chemotherapy or immunotherapy
• Reports taking medications with a known moderate or severe interaction with any of the active ingredients studied, or a substantial safety risk: Anticoagulants, a medication that warns against grapefruit consumption, corticosteroids at doses greater than 5 mgs per day, oral anti-infectives (antibiotics, antifungals, antivirals) to treat an acute infection, antipsychotics, or MAOIs (monoamine oxidase inhibitors)
• Reports a diagnosis of heart disease when a known contraindication exists for any of the active ingredients studied: NYHA (New York Heart Association) Class III or IV congestive heart failure, Atrial fibrillation, Uncontrolled arrhythmias

Related Conditions & MeSH terms

• Neuralgia
• Neuropathic Pain
• Nociceptive Pain
• Pain

Intervention

Dietary Supplement:
• Relief Active Study Product 1.1 Usage
Participants will use their Radicle Relief Active Study Product 1.1 as directed for a period of 6 weeks.
• Relief Active Study Product 1.2 Usage
Participants will use their Radicle Relief Active Study Product 1.2 as directed for a period of 6 weeks.
• Placebo Control Form 1
Participants will use their Placebo Control Form 1 as directed for a period of 6 weeks.
• Relief Active Study Product 2.1 Usage
Participants will use their Radicle Relief Active Study Product 2.1 as directed for a period of 6 weeks.
• Placebo Control Form 2
Participants will use their Placebo Control Form 2 as directed for a period of 6 weeks.
• Placebo Control Form 3
Participants will use their Placebo Control Form 3 as directed for a period of 6 weeks.
• Relief Active Study Product 3.1 Usage
Participants will use their Radicle Relief Active Study Product 3.1 as directed for a period of 6 weeks.
• Relief Active Study Product 3.2 Usage
Participants will use their Radicle Relief Active Study Product 3.2 as directed for a period of 6 weeks.
• Relief Active Study Product 3.3 Usage
Participants will use their Radicle Relief Active Study Product 3.3 as directed for a period of 6 weeks.

Locations

Country	Name	City	State
United States	Radicle Science, Inc	Del Mar	California

Sponsors (1)

Lead Sponsor	Collaborator
Radicle Science

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	Change in focus (cognitive function)	Mean difference in cognitive function score as assessed by PROMIS Cognitive Function 4A (scale 4-20; with higher scores corresponding to greater cognitive function)	6 weeks
Other	Change in mood (emotional distress-depression)	Mean difference in emotional distress score as assessed by PROMIS Emotional Distress- Depression 4A (scale 4-20; with higher scores corresponding to greater levels of emotional distress)	6 weeks
Other	Change in libido	Mean difference in libido score as assessed by PROMIS Sexual Interest 2.0 (scale 2-10; with higher scores corresponding to greater interest in sexual activity)	6 weeks
Primary	Change in pain interference	Mean difference in pain interference score as assessed by Patient Reported Outcome Measurement System (PROMIS) Pain Interference 6A (scale 6-30; with higher scores corresponding to greater pain interference)	6 weeks
Secondary	Change in neuropathic pain	Mean difference in neuropathic pain score as assessed by PROMIS Neuropathic Pain 5A (scale 5-25; with higher scores corresponding to greater neuropathic pain)	6 weeks
Secondary	Change in nociceptive pain	Mean difference in nociceptive pain score as assessed by PROMIS Nociceptive Pain 5A (scale 5-25; with higher scores corresponding to greater nociceptive pain)	6 weeks
Secondary	Change in pain intensity	Mean difference in pain intensity score as assessed by PROMIS Pain Intensity 1A (scale 1-10; with 0 being 'No pain' and 10 being 'The worst imaginable pain')	6 weeks
Secondary	Change in feelings of anxiety	Mean difference in anxiety score as assessed by PROMIS Anxiety 4A (scale 4-20; with higher scores corresponding to more severe anxiety)	6 weeks
Secondary	Change in sleep	Mean difference in sleep score as assessed by PROMIS Sleep Disturbance Form 4A (scale 4-20; with higher scores corresponding to more severe sleep disturbance)	6 weeks
Secondary	Change in energy (fatigue)	Mean difference in fatigue score as assessed by PROMIS Fatigue 4A (scale 4-20; with higher scores corresponding to greater fatigue)	6 weeks
Secondary	Minimal clinically important difference (MCID) in pain interference	Likelihood of experiencing MCID in pain interference score as assessed by PROMIS Pain Interference 6A	6 weeks
Secondary	Minimal clinically important difference (MCID) in neuropathic pain	Likelihood of experiencing MCID in neuropathic pain score as assessed by PROMIS Neuropathic Pain 5A	6 weeks
Secondary	Minimal clinically important difference (MCID) in nociceptive pain	Likelihood of experiencing MCID in nociceptive pain score as assessed by PROMIS Nociceptive Pain 5A	6 weeks
Secondary	Minimal clinically important difference (MCID) in pain intensity	Likelihood of experiencing MCID in pain intensity score as assessed by PROMIS Pain Intensity 1A	6 weeks

External Links

•   Radicle Science, Inc