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Radicle Calm 1: A Study of Health and Wellness Products on Feelings of Anxiety, Stress and Other Health Outcomes

Primary Purpose

Anxiety, Stress

Status

Completed

Phase

Not Applicable

Locations

United States

Study Type

Interventional

Intervention

Radicle Calm Study Placebo Control 1

Radicle Calm Study Placebo Control 2

Radicle Calm Study Active Product 1.1

Radicle Calm Study Active Product 2.1

Radicle Calm Study Active Product 2.2

About this trial

This is an interventional other trial for Anxiety

Eligibility Criteria

21 Years - 105 Years (Adult, Older Adult)All SexesAccepts Healthy Volunteers

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 feelings of anxiety or stress as a primary issue (desire to reduce anxiety or less stress)
Selects feelings of anxiety/stress, looking to improve their feelings of anxiety/stress, 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:

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

Sites / Locations

Radicle Science, Inc

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm 4

Arm 5

Arm Type

Placebo Comparator

Experimental

Arm Label

Placebo Control 1

Placebo Control 2

Active Product 1.1

Active Product 2.1

Active Product 2.2

Arm Description

Calm Product Form 1 - control

Calm Product Form 2 - control

Calm Product Form 1 - active product 1

Calm Product Form 2 - active product 1

Calm Product Form 2 - active product 2

Outcomes

Primary Outcome Measures

Change in feelings of anxiety

Mean difference in feelings of anxiety score as assessed by Patient Reported Outcome Measurement System (PROMIS) Anxiety 8A (scale 8-40; where lower scores correspond to less feelings of anxiety)

Secondary Outcome Measures

Minimal clinically important difference (MCID) in anxiety

Likelihood of experiencing a MCID in anxiety score as assessed by PROMIS Anxiety 8A

Change in stress

Mean difference in stress score as assessed by PROMIS Stress 8A (scale 8-40; where lower scores correspond to less stress)

Minimal clinically important difference (MCID) in stress

Likelihood of experiencing a MCID in stress score as assessed by PROMIS Stress 8A

Change in sleep disturbance

Mean difference in sleep disturbance score as assessed by PROMIS Sleep 4A (scale 4-20; where lower scores correspond to better sleep quality/less sleep disturbance)

Change in cognitive function

Mean difference in cognitive function score as assessed by PROMIS Cognition Function 4A (scale 4-20; where lower scores correspond to poorer cognitive function)

Full Information

NCT ID

NCT05589948

First Posted

October 18, 2022

Last Updated

October 23, 2023

Sponsor

Radicle Science

1. Study Identification

Unique Protocol Identification Number

NCT05589948

Brief Title

Radicle Calm 1: A Study of Health and Wellness Products on Feelings of Anxiety, Stress and Other Health Outcomes

Official Title

Radicle™ Calm 1: A Randomized, Blinded, Placebo-Controlled Direct-to-Consumer Study of Health and Wellness Products on Feelings of Anxiety, Stress and Other Health Outcomes

Study Type

Interventional

2. Study Status

Record Verification Date

October 2023

Overall Recruitment Status

Completed

Study Start Date

October 10, 2022 (Actual)

Primary Completion Date

May 3, 2023 (Actual)

Study Completion Date

August 15, 2023 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Sponsor

Name of the Sponsor

Radicle Science

4. Oversight

Studies a U.S. FDA-regulated Drug Product

Studies a U.S. FDA-regulated Device Product

Data Monitoring Committee

5. Study Description

Brief Summary

A randomized, blinded, placebo-controlled, direct-to-consumer study assessing the impact of health and wellness products on feelings of anxiety, stress 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 feelings of anxiety and/or stress, (2) indicate an interest in taking a health and wellness product to potentially improve their anxiety and/or stress, 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 are pregnant, trying to become pregnant, or breastfeeding will be excluded. Those taking certain medications will be excluded. Self-reported data will be 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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Anxiety, Stress

7. Study Design

Primary Purpose

Other

Study Phase

Not Applicable

Interventional Study Model

Parallel Assignment

Model Description

Participants will be stratified based on gender at birth then randomized to one of the study arms

Masking

ParticipantInvestigator

Masking Description

Participants will be blinded to the product they receive.

Allocation

Randomized

Enrollment

1211 (Actual)

8. Arms, Groups, and Interventions

Arm Title

Placebo Control 1

Arm Type

Placebo Comparator

Arm Description

Calm Product Form 1 - control

Arm Title

Placebo Control 2

Arm Type

Placebo Comparator

Arm Description

Calm Product Form 2 - control

Arm Title

Active Product 1.1

Arm Type

Experimental

Arm Description

Calm Product Form 1 - active product 1

Arm Title

Active Product 2.1

Arm Type

Experimental

Arm Description

Calm Product Form 2 - active product 1

Arm Title

Active Product 2.2

Arm Type

Experimental

Arm Description

Calm Product Form 2 - active product 2

Intervention Type

Dietary Supplement

Intervention Name(s)

Radicle Calm Study Placebo Control 1

Intervention Description

Participants will use their Radicle Calm Placebo Control Product 1 as directed for a period of 4 weeks.

Intervention Type

Dietary Supplement

Intervention Name(s)

Radicle Calm Study Placebo Control 2

Intervention Description

Participants will use their Radicle Calm Placebo Control Product 2 as directed for a period of 4 weeks.

Intervention Type

Dietary Supplement

Intervention Name(s)

Radicle Calm Study Active Product 1.1

Intervention Description

Participants will use their Radicle Calm Active Product 1.1 as directed for a period of 4 weeks.

Intervention Type

Dietary Supplement

Intervention Name(s)

Radicle Calm Study Active Product 2.1

Intervention Description

Participants will use their Radicle Calm Active Product 2.1 as directed for a period of 4 weeks.

Intervention Type

Dietary Supplement

Intervention Name(s)

Radicle Calm Study Active Product 2.2

Intervention Description

Participants will use their Radicle Calm Active Product 2.2 as directed for a period of 4 weeks.

Primary Outcome Measure Information:

Title

Change in feelings of anxiety

Description

Mean difference in feelings of anxiety score as assessed by Patient Reported Outcome Measurement System (PROMIS) Anxiety 8A (scale 8-40; where lower scores correspond to less feelings of anxiety)

Time Frame

4 weeks

Secondary Outcome Measure Information:

Title

Minimal clinically important difference (MCID) in anxiety

Description

Likelihood of experiencing a MCID in anxiety score as assessed by PROMIS Anxiety 8A

Time Frame

4 weeks

Title

Change in stress

Description

Mean difference in stress score as assessed by PROMIS Stress 8A (scale 8-40; where lower scores correspond to less stress)

Time Frame

4 weeks

Title

Minimal clinically important difference (MCID) in stress

Description

Likelihood of experiencing a MCID in stress score as assessed by PROMIS Stress 8A

Time Frame

4 weeks

Title

Change in sleep disturbance

Description

Mean difference in sleep disturbance score as assessed by PROMIS Sleep 4A (scale 4-20; where lower scores correspond to better sleep quality/less sleep disturbance)

Time Frame

4 weeks

Title

Change in cognitive function

Description

Mean difference in cognitive function score as assessed by PROMIS Cognition Function 4A (scale 4-20; where lower scores correspond to poorer cognitive function)

Time Frame

4 weeks

Other Pre-specified Outcome Measures:

Title

Change in mood (emotional distress)

Description

Mean difference in mood score as assessed by PROMIS Emotional Distress-Depression 4A (scale 4-20; where lower scores correspond to lower levels of emotional distress)

Time Frame

4 weeks

Title

Change in libido

Description

Mean difference in libido score as assessed by PROMIS Sexual Interest 2.0 (scale 4-20; where lower scores correspond to less interest in sexual activity)

Time Frame

4 weeks

10. Eligibility

Sex

All

Minimum Age & Unit of Time

21 Years

Maximum Age & Unit of Time

105 Years

Accepts Healthy Volunteers

Eligibility Criteria

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 feelings of anxiety or stress as a primary issue (desire to reduce anxiety or less stress) Selects feelings of anxiety/stress, looking to improve their feelings of anxiety/stress, 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: 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 (monoamine oxidase inhibitors) Reports current or recent (within 3 months) use of chemotherapy, immunotherapy, or oral anti-infectives (antibiotics, antifungals, antivirals) to treat an acute infection

Overall Study Officials:

First Name & Middle Initial & Last Name & Degree

Emily K. Pauli, PharmD

Organizational Affiliation

Radicle Science, Inc

Official's Role

Principal Investigator

Facility Information:

Facility Name

Radicle Science, Inc

City

Del Mar

State/Province

California

ZIP/Postal Code

92014

Country

United States

12. IPD Sharing Statement

Plan to Share IPD

IPD Sharing Plan Description

Data will not be shared with researchers outside of Radicle Collaborators on this study.

Links:

URL

http://radiclescience.com

Description

Radicle Science, Inc

Learn more about this trial

Radicle Calm 1: A Study of Health and Wellness Products on Feelings of Anxiety, Stress and Other Health Outcomes

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