Radicle Relaxation™ CIX: A Study Assessing the Impact of Health and Wellness Products on Stress and Related Health Outcomes

NCT07835997 | Not Yet Recruiting

• 1 other identifier: RADX_P_2608_CIX
• Study Type: interventional
• Target: 550
• Locations: 1 country
• Sites: 1

Brief Summary

Radicle Relaxation™ CIX: A randomized, double-blind, placebo-controlled study assessing the impact of health and wellness products on stress and related health outcomes

Conditions

Stress

Outcome Measures

Primary Outcomes (1)

• Change in feelings of stress

  Change in feelings of stress: Difference between rates of change over time in feelings of stress score as assessed Perceived Stress Scale 10 (PSS-10) (scale 1-5; where lower scores correspond to less stress)

  9 weeks

Secondary Outcomes (3)

• Change in feelings of anxiety

  9 weeks

• Change in sleep

  9 weeks

• Change in mood (emotional distress-depression)

  9 weeks

Other Outcomes (4)

• Minimal clinically important difference (MCID) in feelings of stress

  9 weeks

• Minimal clinically important difference in feelings of anxiety

  9 weeks

• Minimal clinically important difference (MCID) in sleep

  9 weeks

Study Arms (2)

Active Relaxation Product 1

EXPERIMENTAL

Active Relaxation Product 1

Dietary Supplement: Active Relaxation Product 1

Placebo Relaxation Control

PLACEBO COMPARATOR

Placebo Relaxation Control

Dietary Supplement: Placebo Relaxation Control

Interventions

Placebo Relaxation Control DIETARY_SUPPLEMENT

Participants will use their Placebo Relaxation Control as directed for a period of 8 weeks

Placebo Relaxation Control

Active Relaxation Product 1 DIETARY_SUPPLEMENT

Participants will use their Active Relaxation Product 1 as directed for a period of 8 weeks

Active Relaxation Product 1

Eligibility Criteria

• Age: 21 Years - 105 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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
• Lack of reliable daily access to the internet
• Participants residing in the states of New York, New Jersey, or Rhode Island are eligible to enroll in the main study and will complete all primary study activities. However, these participants are not eligible to participate in the biomarker collection. This restriction is due to state regulatory requirements governing direct-to-consumer at-home laboratory specimen collection and processing that cannot be accommodated within the fully decentralized design of the biomarker collection. No alternative collection pathway is available under the current protocol.
• To ensure compliance, state-of-residence logic is built into the enrollment platform. Participants who indicate a residential address in New York, New Jersey, or Rhode Island will not be presented with the biomarker collection consent or any associated study materials. This automated screening ensures that ineligible participants are not inadvertently enrolled in the collection. These participants will otherwise proceed through full main study enrollment and participation without interruption.

Sponsors & Collaborators

• Radicle Science: lead

Study Sites (1)

Radicle Science, Inc

Del Mar, California, 92014, United States

Location

Related Links

• Related Info

Study Officials

• Susan Hewlings

  Radicle Science

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Study Manager

CONTACT

858-779-0086; studymgmt@radiclescience.com

Susan Hewlings

CONTACT

760-281-3898; susan.hewlings@radiclescience.com

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, INVESTIGATOR
• Masking Details: The investigator is blinded to the participants' assigned study products. Participants are blinded to the study product they received.
• Purpose: OTHER
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Model Details: Eligible participants who complete all required enrollment steps will be stratified using a sequential randomization model designed to support balanced allocation across study product groups. Stratification will be based on sex at birth (Female or Non-Female), age (21-44, 45-64, or 65+), biospecimen collection (Yes or No), and health outcome score, with categories and thresholds determined according to the applicable scoring guidelines. Participants will then be randomized sequentially based on all stratification factors collectively to promote an even distribution of participant characteristics across the study product groups. Following randomization, participants will receive their assigned study product along with an insert containing additional information regarding product use and study procedures.

Study Record Dates

• First Submitted: September 17, 2026
• First Posted: September 23, 2026
• Study Start: September 17, 2026
• Primary Completion (Estimated): September 17, 2027
• Study Completion (Estimated): September 17, 2027
• Last Updated: September 23, 2026

Record last verified: 2026-09

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)