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Completed

NCT Number: NCT06749288

Radicle Revive 24: A Study of Health and Wellness Products on Menopausal Health and Related Health Outcomes

A randomized, double-blind, placebo-controlled, direct-to-consumer trial assessing the impact of health and wellness products on hormonal health and associated health outcomes in women with menopausal health issues

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Key information

Conditions

Menopause Anxiety Anxiety Disorders Behavior Behavioral Symptoms Cognitive Function Depression Fatigue Libido Mental Disorders Nervous System Diseases Parasomnias Pathological Conditions, Signs and Symptoms Signs and Symptoms Sleep Disturbance Sleep Wake Disorders

Age range

21 year–105 year

Sex eligibility

Female

Study type

Interventional

Phase

Not applicable

Primary location

Radicle Science, Inc

Del Mar, California, 92014, United States

About this study

This is a randomized, double-blind, placebo-controlled study conducted with adult participants, residing in the United States.

Eligible participants (1) are females, (2) have menopausal health issues for 3 months or longer, (3) have the opportunity to improve by at least 30%, and (4) express acceptance in taking study products and not knowing the formulation identities until the end of the study.

Participants that report a known cardiac dysfunction, liver or kidney disease may be excluded. Participants that report a known contraindication or with well-established, significant safety concerns due to illness will be excluded. Heavy drinkers and women who are pregnant or breastfeeding will be excluded. Participants that report taking medications with a known contraindication or with well-established, significant safety concerns will be excluded.

Self-reported data are collected electronically from eligible participants for 7 weeks. Participant reports of health indicators will be collected at 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.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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 MAO

Treatment and study plan

Radicle Revive Placebo Control Form 4.1

Dietary Supplement

Participants will use their Placebo Control Form 1 as directed for a period of 6 weeks.

Radicle Revive Active Study Product 4.1 Usage

Dietary Supplement

Participants will use their Radicle Revive Active Study Product 1.1 as directed for a period of 6 weeks.

Primary outcomes

  1. Change in feelings of anxiety

    Time frame: 6 weeks

    Mean difference in anxiety score as assessed by PROMIS Anxiety 4A (scale 4-20; with higher scores corresponding to more severe anxiety)

  2. Change in feelings of anxiety

    Time frame: 6 weeks

    Mean difference in anxiety score as assessed by PROMIS Anxiety 8A (scale 8-40; with higher scores corresponding to more severe anxiety)

  3. Change in feelings of depression

    Time frame: 6 weeks

    Mean difference in depression score as assessed by PROMIS Depression 4A (scale 4-20; with higher scores corresponding to more severe depression)

  4. Change in cognitive function

    Time frame: 6 weeks

    Mean difference in cognitive function score as assessed by PROMIS Cognitive Function 4A (scale 4-20; with lower scores corresponding to better cognitive function)

  5. Change in cognitive function

    Time frame: 6 weeks

    Mean difference in cognitive function score as assessed by PROMIS Cognitive Function 8A (scale 8-40; with lower scores corresponding to better cognitive function)

  6. Change in sleep disturbance

    Time frame: 6 weeks

    Mean difference in sleep disturbance score as assessed by PROMIS Sleep Disturbance 4A (scale 4-20; with higher scores corresponding to more severe sleep disturbance)

  7. Change in sleep disturbance

    Time frame: 6 weeks

    Mean difference in sleep disturbance score as assessed by PROMIS Sleep Disturbance 8A (scale 8-40; with higher scores corresponding to more severe sleep disturbance)

  8. Change in fatigue

    Time frame: 6 weeks

    Mean difference in fatigue score as assessed by PROMIS Fatigue 4A (scale 4-20; with higher scores corresponding to more severe fatigue)

  9. Change in feelings of depression

    Time frame: 6 weeks

    Mean difference in depression score as assessed by PROMIS Depression 8A (scale 8-40; with higher scores corresponding to more severe depression)

  10. Change in fatigue

    Time frame: 6 weeks

    Mean difference in fatigue score as assessed by PROMIS Fatigue 8A (scale 8-40; with higher scores corresponding to more severe fatigue)

  11. Change in Pain Interference

    Time frame: 6 weeks

    Mean difference in pain interference score as assessed by PROMIS Pain Interference 6A (scale 6-30; with higher scores corresponding to more severe pain interference)

  12. Change in pain intensity

    Time frame: 6 weeks

    Mean difference in pain intensity score as assessed by PROMIS Pain Intensity 3A (scale 3-15; with higher scores corresponding to more severe pain intensity)

  13. Change in interest in sexual activity

    Time frame: 6 weeks

    Mean difference in interest in sexual activity score as assessed by PROMIS Sexual Function and Satisfaction v2.0 (scale 2-10; with lower scores corresponding to less interest in sexual activity)

Secondary outcomes

  1. Change in other menopausal health issues

    Time frame: 6 weeks

    Other menopausal health issues assessed by Radicle General Menopausal Health Issues (Point range: 10 - 48; where higher is more severe menopausal health issues)

  2. Minimal clinically important difference (MCID) in feelings of anxiety

    Time frame: 6 weeks

    Likelihood of achieving a MCID in anxiety, as measured by PROMIS Anxiety 4a (4-20; where lower scores indicate less anxiety).

  3. Minimal clinically important difference (MCID) in feelings of anxiety

    Time frame: 6 weeks

    Likelihood of achieving a MCID in anxiety, as measured by PROMIS Anxiety 8a (8-40; where lower scores indicate less anxiety).

  4. Minimal clinically important difference (MCID) in feelings of depression

    Time frame: 6 weeks

    Likelihood of achieving a MCID in depression , as measured by PROMIS Depression 4a (4-20; where lower scores indicate less depression).

  5. Minimal clinically important difference (MCID) in feelings of depression

    Time frame: 6 weeks

    Likelihood of achieving a MCID in depression , as measured by PROMIS Depression 8a (8-40; where lower scores indicate less depression).

  6. Minimal clinically important difference (MCID) in cognitive function

    Time frame: 6 weeks

    Likelihood of achieving a MCID in cognitive function , as measured by PROMIS cognitive function 4a (4-20; where lower scores indicate poorer cognitive function).

  7. Minimal clinically important difference (MCID) in cognitive function

    Time frame: 6 weeks

    Likelihood of achieving a MCID in cognitive function , as measured by PROMIS cognitive function 8a (8-40; where lower scores indicate poorer cognitive function).

  8. Minimal clinically important difference (MCID) in sleep disturbance

    Time frame: 6 weeks

    Likelihood of achieving a MCID in sleep disturbance , as measured by PROMIS Sleep Disturbance 4a (4-20; where lower scores indicate less sleep disturbance).

  9. Minimal clinically important difference (MCID) in sleep disturbance

    Time frame: 6 weeks

    Likelihood of achieving a MCID in sleep disturbance , as measured by PROMIS Sleep Disturbance 8a (8-40; where lower scores indicate less sleep disturbance).

  10. Minimal clinically important difference (MCID) in fatigue

    Time frame: 6 weeks

    Likelihood of achieving a MCID in fatigue, as measured by PROMIS Fatigue 4a (4-20; where lower scores indicate less fatigue).

  11. Minimal clinically important difference (MCID) in fatigue

    Time frame: 6 weeks

    Likelihood of achieving a MCID in fatigue, as measured by PROMIS Fatigue 8a (8-40; where lower scores indicate less fatigue).

  12. Minimal clinically important difference (MCID) in pain interference

    Time frame: 6 weeks

    Likelihood of achieving a MCID in pain interference, as measured by PROMIS Pain interference (6-30; where lower scores indicate less pain interference).

  13. Minimal clinically important difference (MCID) in pain intensity

    Time frame: 6 weeks

    Likelihood of achieving a MCID in pain intensity, as measured by PROMIS Pain intensity (3-15; where lower scores indicate less pain intensity).

  14. Minimal clinically important difference (MCID) in interest in sexual function

    Time frame: 6 weeks

    Likelihood of achieving a MCID in interest in sexual activity, as measured by PROMIS Sexual Function and Satisfaction v2.0 (scale 2-10; with lower scores corresponding to less interest in sexual activity)

Sponsors and collaborators

Lead sponsor

Radicle Science

Industry

Registry information

Official study title

Radicle Revive™ 24: A Randomized, Double-Blind, Placebo-Controlled, Direct-to-Consumer Trial Assessing the Impact of Health and Wellness Products on Hormonal Health and Associated Health Outcomes in Women With Menopausal Health Issues

Important dates

Study start
2025
Primary completion
2025
Study completion
2025
First posted
Dec 27, 2024
Registry last updated
Jul 4, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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