Wellness Products for Anxiety

Overseen By Study Manager

Age: 18+

Sex: Any

Trial Phase: Academic

Sponsor: Radicle Science

Must not be taking: Anticoagulants, Antidepressants, Antipsychotics, others

Disqualifiers: Pregnancy, Heavy drinking, Cardiac dysfunction, others

Compensation: Varies

Number of Visits: Unknown

Duration: 6 weeks

502 Participants Needed

Trial Summary

Will I have to stop taking my current medications?

The trial requires that you stop taking certain medications that could interact with the study products. These include blood thinners, blood pressure medications, anxiety and depression medications, and others. If you're on any of these, you may need to stop them to participate.

What data supports the effectiveness of the drug Calm Active Study Product 1.1 for anxiety?

Research shows that an extract of Withania somnifera, a component similar to those in Calm Active Study Product 1.1, significantly reduced anxiety symptoms in patients compared to a placebo, with 88.2% of patients showing improvement. ^{1 2 3 4 5}

Is the treatment generally safe for humans?

Research suggests that kava, a component of the treatment, is generally safe for short-term use at recommended doses, with most side effects being mild and reversible. However, there have been reports of serious side effects, including liver damage, so further research is needed to fully understand the risks. ^{6 7 8 9 10}

How does the Calm Active Study Product 1.1 treatment for anxiety differ from other treatments?

The Calm Active Study Product 1.1 is unique because it is part of a clinical trial that includes a placebo control, which helps determine its effectiveness compared to no active treatment. Unlike other treatments that may use herbal extracts like kava or valerian, this study focuses on the placebo effect, which has shown significant reductions in anxiety symptoms in some trials. ^{1 2 7 11 12}

What is the purpose of this trial?

A randomized, double-blind, placebo-controlled study assessing the impact of health and wellness products on feelings of anxiety and related health outcomes

Research Team

Emily K. Pauli, PharmD

Principal Investigator

Radicle Science, Inc

Eligibility Criteria

Adults over 21 in the US who want to reduce anxiety and can improve their health by at least 20%. Must be willing to take an unknown product (active or placebo) and have internet access. Excludes those with major recent illnesses, heavy drinkers, certain chronic diseases, pregnant/breastfeeding women, other trial participants, and those on conflicting medications.

Inclusion Criteria

I want to feel less anxious.

Has the opportunity for at least 20% improvement in their primary health outcome

Resides in the United States

Exclusion Criteria

I've had a major illness or surgery recently that could affect my safety in the trial.

Unable to provide a valid US shipping address and mobile phone number

Reports being a heavy drinker (defined as drinking 3 or more alcoholic beverages per day)

Timeline

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Treatment

Participants receive the study product or placebo for 6 weeks, with self-reported data collected electronically

6 weeks

All assessments are electronic; no in-person visits

Follow-up

Participants are monitored for safety and effectiveness after treatment

4 weeks

Treatment Details

Interventions

• Calm Active Study Product 1.1
• Placebo Control Form 1

Trial Overview The study is testing a 'Calm Active Study Product' against a placebo to see if it helps with anxiety. Participants won't know which one they're taking. It's randomized (assigned by chance) and double-blind (neither researchers nor participants know who's getting what).

Participant Groups

Group I: Active Product 6.1.1 Experimental Treatment 1 Intervention

Calm Product 6.1 - active product 1

Group II: Active Product 1.1 Experimental Treatment 1 Intervention

Calm Product Form 1 - active product 1

Group III: Placebo Control 1 Placebo Group 1 Intervention

Calm Product Form 1 - control

Group IV: Placebo Control 6.1.0 Placebo Group 1 Intervention

Calm Product 6.1 - control

Who Is Running the Clinical Trial?

Radicle Science

Lead Sponsor

Trials

24

Recruited

46,200+

Findings from Research

In a double-blind, placebo-controlled study involving 39 patients with anxiety disorders, the ethanolic extract of Aswagandha showed significant efficacy, with 88.2% of patients in the treatment group meeting response criteria at 6 weeks compared to 50% in the placebo group.

The extract was well-tolerated, with no significant increase in adverse effects compared to the placebo, suggesting it is a safe option for anxiety treatment and warrants further research.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

A double-blind, placebo-controlled evaluation of the anxiolytic efficacy ff an ethanolic extract of withania somnifera. Andrade, C., Aswath, A., Chaturvedi, SK., et al.[2022]

Kava extracts are generally well tolerated and associated with rare, mild, and reversible adverse events when used as a short-term treatment for anxiety, based on a systematic review of clinical evidence.

However, serious adverse events, including liver damage and neurological complications, have been reported, indicating the need for further research to better understand the risks associated with kava use.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

A systematic review of the safety of kava extract in the treatment of anxiety. Stevinson, C., Huntley, A., Ernst, E.[2018]

In a review of 99 randomized controlled trials on cognitive behavioral therapy for insomnia (CBTI), only 32.3% addressed adverse events, highlighting a significant gap in monitoring during psychological treatment compared to pharmacotherapy.

Only 7.1% of the studies met all criteria for adequate reporting of adverse events, indicating a need for improved standards in documenting potential negative effects of CBTI to ensure patient safety and treatment efficacy.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Reporting of adverse events in cognitive behavioural therapy for insomnia: A systematic examination of randomised controlled trials. Condon, HE., Maurer, LF., Kyle, SD.[2021]

References

1. India pubmed.ncbi.nlm.nih.gov

A double-blind, placebo-controlled evaluation of the anxiolytic efficacy ff an ethanolic extract of withania somnifera. [2022]

2. United States pubmed.ncbi.nlm.nih.gov

Characteristics of placebo response during long-term treatment of panic disorder. [2013]

3. Germany pubmed.ncbi.nlm.nih.gov

Can an inert sleeping pill affect sleep? Effects on polysomnographic, behavioral and subjective measures. [2018]

4. United States pubmed.ncbi.nlm.nih.gov

Complementary and alternative treatments for late-life depression, anxiety, and sleep disturbance: a review of randomized controlled trials. [2019]

5. England pubmed.ncbi.nlm.nih.gov

Role of placebo effects in pain and neuropsychiatric disorders. [2019]

6. Netherlands pubmed.ncbi.nlm.nih.gov

Clinical efficacy of kava extract WS 1490 in sleep disturbances associated with anxiety disorders. Results of a multicenter, randomized, placebo-controlled, double-blind clinical trial. [2019]

7. United States pubmed.ncbi.nlm.nih.gov

An internet-based randomized, placebo-controlled trial of kava and valerian for anxiety and insomnia. [2022]

8. New Zealand pubmed.ncbi.nlm.nih.gov

A systematic review of the safety of kava extract in the treatment of anxiety. [2018]

9. India pubmed.ncbi.nlm.nih.gov

Background noise in healthy volunteers--a consideration in adverse drug reaction studies. [2013]

10. England pubmed.ncbi.nlm.nih.gov

Reporting of adverse events in cognitive behavioural therapy for insomnia: A systematic examination of randomised controlled trials. [2021]

11. England pubmed.ncbi.nlm.nih.gov

Double-blind placebo controlled trial of the anxiolytic effects of a standardized Echinacea extract. [2020]

12. Germany pubmed.ncbi.nlm.nih.gov

Efficacy of a special Kava extract (Piper methysticum) in patients with states of anxiety, tension and excitedness of non-mental origin - A double-blind placebo-controlled study of four weeks treatment. [2012]