PainNCT05589935
Radicle Relief 1: A Study of Health and Wellness Products on Pain and Other Health Outcomes
A study testing Relief Study Product Usage in people with Pain and Nociceptive Pain, run by Radicle Science at 1 site in United States.
Trial summary
A randomized, blinded, placebo-controlled study assessing the impact of health and wellness products on pain and other health outcomes Read more about this study
- Who is it for?
- Ages 21 to 105 yearsHealthy volunteers can take part
- Conditions the study is for
- Pain, Nociceptive Pain, Neuropathic Pain
- What is being tested?
- Relief Study Product Usage
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 457 participants
- Where
- 1 siteUnited States
- Study dates
- 22 Nov 2022to 24 May 2023
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 21 to 105 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country.
About this study
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
A randomized, blinded, placebo-controlled study assessing the impact of health and wellness products on pain and other health outcomes
Read the detailed 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
- Conditions
- Pain, Nociceptive Pain, Neuropathic Pain
- Being tested
- Relief Study Product Usage
- Medical subject headings
- Pain, Nociceptive Pain, Neuralgia
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Relief Study Product UsageDietary supplement
Participants instructed to use study product daily as directed for a period of 4 weeks
| Study group | Role | What they receive |
|---|---|---|
| Control 1 | Placebo comparator | Relief Product Form 1 - control Receives: Dietary Supplement: Relief Study Product Usage |
| Active Product 1.1 | Experimental | Relief Product Form 1 - active product 1 Receives: Dietary Supplement: Relief Study Product Usage |
What is being measured
The primary outcome is the main question the study is designed to answer.
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]
Measured: 4 weeks
Secondary outcomes (9)
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]
Measured: 4 weeks
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]
Measured: 4 weeks
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']
Measured: 4 weeks
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]
Measured: 4 weeks
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]
Measured: 4 weeks
Minimal clinically important difference (MCID) in pain interference
Likelihood of experiencing MCID in pain interference score as assessed by PROMIS Pain Interference 6A
Measured: 4 weeks
Minimal clinically important difference (MCID) in neuropathic pain
Likelihood of experiencing MCID in neuropathic pain score as assessed by PROMIS Neuropathic Pain 5A
Measured: 4 weeks
Minimal clinically important difference (MCID) in nociceptive pain
Likelihood of experiencing MCID in nociceptive pain score as assessed by PROMIS Nociceptive Pain 5A
Measured: 4 weeks
Minimal clinically important difference (MCID) in pain intensity
Likelihood of experiencing MCID in pain intensity score as assessed by PROMIS Pain Intensity 1A
Measured: 4 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted21 Oct 2022
- Study start22 Nov 2022
- Primary completion23 Dec 2022
- Study completion24 May 2023
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for PainStudies of the same condition, open and under way.
- More trials run by Radicle ScienceThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- Participants will be stratified based on gender at birth then randomized to one of the study arms
- Masking
- Double blind
- Who is masked
- Participant, Investigator
- Enrolment
- 457 participants (actual)
Sponsor and investigators
- Lead sponsor
- Radicle Science
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Emily K. Pauli, PharmD, Principal investigator, Radicle Science Inc.
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05589935
- Sponsor's protocol ID
- RADX-22D05
- Status last verified
- Nov 2023
- First submitted
- 18 Oct 2022
- Last updated
- 22 Nov 2023
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: Data will not be shared with researchers outside of Radicle Collaborators on this study.
Study at a glance
From the registry record, last updated by the sponsor on 22 Nov 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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
- ClinicalTrials.gov ID
- NCT05589935
- Acronym / sponsor ID
- RADX-22D05
- Conditions
- Pain, Nociceptive Pain, Neuropathic Pain
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 457 participants (actual)
- Lead sponsor
- Radicle ScienceIndustry (pharma, biotech, devices)
- Study start
- 22 Nov 2022 (actual)
- Primary completion
- 23 Dec 2022 (actual)
- Study completion
- 24 May 2023 (actual)
- First posted
- 21 Oct 2022 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
A randomized, blinded, placebo-controlled study assessing the impact of health and wellness products on pain and other health outcomes
Detailed 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
Study design
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, investigator)
- Number of arms
- 2
- Model description
- Participants will be stratified based on gender at birth then randomized to one of the study arms
| Arm | Type | Receives |
|---|---|---|
| Control 1 | Placebo comparator | Dietary Supplement: Relief Study Product UsageRelief Product Form 1 - control |
| Active Product 1.1 | Experimental | Dietary Supplement: Relief Study Product UsageRelief Product Form 1 - active product 1 |
Who may qualify
- Ages
- 21 to 105 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- 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
Key exclusion criteria (8 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Relief Study Product UsageParticipants instructed to use study product daily as directed for a period of 4 weeks | Dietary supplement | Active Product 1.1, Control 1 |
Primary outcome
Change in pain interference
Time frame: 4 weeks
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]
9 secondary outcomes
Change in neuropathic pain
Time frame: 4 weeks
Change in nociceptive pain
Time frame: 4 weeks
Change in pain intensity
Time frame: 4 weeks
Change in feelings of anxiety
Time frame: 4 weeks
Change in sleep disturbance
Time frame: 4 weeks
Minimal clinically important difference (MCID) in pain interference
Time frame: 4 weeks
Minimal clinically important difference (MCID) in neuropathic pain
Time frame: 4 weeks
Minimal clinically important difference (MCID) in nociceptive pain
Time frame: 4 weeks
Minimal clinically important difference (MCID) in pain intensity
Time frame: 4 weeks
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 22 Nov 2023.
- Radicle Science, IncLink provided by the sponsor.
- Individual participant dataSharing planned: No. Data will not be shared with researchers outside of Radicle Collaborators on this study.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Emily K. Pauli, PharmD principal investigator
Radicle Science Inc.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Relief Study Product Usage in people with Pain and Nociceptive Pain, run by Radicle Science at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 8 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 22 Nov 2023. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change in pain interference (time frame: 4 weeks). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 22 Nov 2023.