Radicle Relief 1: A Study of Health and Wellness Products on Pain and Other Health Outcomes

Pain Clinical Trial

Official title:

Radicle Relief 1™: A Randomized, Blinded, Placebo-Controlled Direct-to-Consumer Study of Health and Wellness Products on Pain and Other Health Outcomes

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT05589935
• Other study ID #: RADX-22D05
• Status: Completed
• Phase: N/A
• Start date: November 22, 2022
• Est. completion date: May 24, 2023

Study information

• Verified date: November 2023
• Source: Radicle Science
• Contact: n/a
• 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 up to 300 adult participants per study arm, 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 relieve 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 5 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: Completed
• Enrollment: 457
• Est. completion date: May 24, 2023
• Est. primary completion date: December 23, 2022
• 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 pain as a primary issue (desire for less pain)

• Selects their desire for less pain and/or reduce reliance on medications 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 physical shipping address

• 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

• Lack of reliable daily access to the internet

• Reports taking anticoagulants, any medication that warns against grapefruit consumption, corticosteroids at doses greater than 5 mgs per day, or MAOIs

• Reports current or recent (within 3 months) use of chemotherapy, immunotherapy, or oral anti-infectives (antibiotics, antifungals, antivirals) to treat an acute infection

Related Conditions & MeSH terms

• Neuralgia
• Neuropathic Pain
• Nociceptive Pain
• Pain

Intervention

Dietary Supplement:
• Relief Study Product Usage
Participants instructed to use study product daily as directed for a period of 4 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 energy (fatigue)	Mean difference in fatigue score as assessed by PROMIS Fatigue 4A [scale 4-20; with higher scores corresponding to greater fatigue]	4 weeks
Other	Change in 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]	4 weeks
Other	Change in emotional distress	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]	4 weeks
Other	Change in sexual interest	Mean difference in sexual interest as assessed by PROMIS Sexual Interest 2.0 [scale 2-10; with higher scores corresponding to greater interest in sexual activity]	4 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]	4 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]	4 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]	4 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']	4 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]	4 weeks
Secondary	Change in sleep disturbance	Mean difference in sleep disturbance score as assessed by PROMIS Sleep Disturbance Form 4A [scale 4-20; with higher scores corresponding to more severe sleep disturbance]	4 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	4 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	4 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	4 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	4 weeks

External Links

•   Radicle Science, Inc