250 Participants NeededMy employer runs this trial

Botanical Extract for Situational Anxiety

AS
Overseen ByAlethios Support
Age: 18 - 65
Sex: Any
Trial Phase: Academic
Sponsor: PLT Health Solutions

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial aims to determine if a botanical supplement can reduce anxiety during stressful situations. Participants will use both the supplement and a placebo to compare effects. The trial seeks individuals who experience stress or anxiety at least once a week. Participants must agree to avoid cannabis and certain calming supplements during the study. As an unphased trial, it offers participants the chance to contribute to early research on alternative anxiety treatments.

Do I have to stop taking my current medications?

You can continue taking your current medications as long as they are stable and not used to treat anxiety. You must also avoid using certain dietary supplements or herbal products like ashwagandha, L-theanine, or St. John's Wort during the study.

Is there any evidence suggesting that this trial's treatments are likely to be safe?

Research has shown that Sceletium tortuosum, or kanna, is generally safe for use. Studies have found that a standardized extract of this plant, used in dietary supplements, can reduce anxiety without major side effects. Most users report only mild to moderate side effects, if any.

Kanna has been safely included in various dietary supplements in the United States and Canada. Although the FDA has not approved it, current evidence suggests it aids in emotional balance and promotes calmness. The study uses a 25 mg dose, which other research has found effective in reducing anxiety.

While information on long-term use is limited, short-term use appears safe for most people. For those considering joining a trial, current findings suggest it is a low-risk option.12345

Why are researchers excited about this trial?

Unlike the standard treatments for situational anxiety, which often include medications like benzodiazepines or SSRIs, this botanical extract is derived from the Sceletium tortuosum plant. Researchers are excited because it offers a natural alternative with potentially fewer side effects. This extract is taken as needed, which could provide rapid relief without the long-term commitment required by many traditional medications. Additionally, the unique mechanism of action of this plant-based extract might offer a new way to manage anxiety symptoms.

What evidence suggests that this botanical extract is effective for situational anxiety?

Research has shown that Sceletium tortuosum, also known as Kanna, may help reduce anxiety. One study found it improved thinking skills and lowered anxiety in healthy older adults. Another study demonstrated that Sceletium tortuosum reduced anxiety in healthy individuals by altering brain wave patterns. This plant extract is also associated with improved mood and sleep. In this trial, participants will receive either a 25 mg dose of a standardized extract from the aerial parts of Sceletium tortuosum or a placebo. These findings suggest it might help manage symptoms of acute stress and anxiety in certain situations.25678

Who Is on the Research Team?

DS

Dawna Salter-Farfan, PhD, RD

Principal Investigator

PLT Health Solutions

Are You a Good Fit for This Trial?

This trial is for healthy adults aged 18-59 who experience situational anxiety or stress at least once a week, have moderate to high self-reported anxiety, can use digital surveys, are not using supplements or medications for anxiety, and agree to avoid cannabis and certain calming supplements during the study. Women of childbearing age must use birth control.

Inclusion Criteria

9. Subject agrees to abstain from cannabis use for the duration of the study period
I feel stressed or anxious at least once a week.
3. Score of ≥ 40 on a self-assessment of typical anxiety on a Visual Analog Scale where 0 represents "not stressed or anxious" and 100 represents "extremely stressed or anxious."
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Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Treatment Period 1

Participants self-identify episodes of acute stress or situational anxiety and rate feelings of anxiety over the next five hours after taking the study product assigned for Period 1

2 weeks
Decentralized, self-reported

Washout

Participants do not take any study product nor complete any surveys

1 week

Treatment Period 2

Participants self-identify episodes of acute stress or situational anxiety and rate feelings of anxiety over the next five hours after taking the study product assigned for Period 2

2 weeks
Decentralized, self-reported

Follow-up

Participants are monitored for adverse events and satisfaction with the treatment

4 weeks

What Are the Treatments Tested in This Trial?

Interventions

  • Botanical extract for anxiety

Trial Overview

The study compares a botanical supplement with a placebo capsule in reducing feelings of mild acute stress or situational anxiety. It uses a double-blind, crossover design where each participant tries both treatments at different times without knowing which one they receive first.

How Is the Trial Designed?

2

Treatment groups

Active Control

Placebo Group

Group I: Dietary SupplementActive Control1 Intervention
Group II: PlaceboPlacebo Group1 Intervention

Find a Clinic Near You

Who Is Running the Clinical Trial?

PLT Health Solutions

Lead Sponsor

Citations

Sceletium for Managing Anxiety, Depression and Cognitive ...

The results indicate that Zembrin® improves some aspects of cognitive function and decreases anxiety in healthy older adults [45]. In two small randomized, ...

A Chewable Cure “Kanna”: Biological and Pharmaceutical ...

The results showed significant comprehensive anti-inflammatory effects of Sceletium extracts ... The Effects of Sceletium tortuosum in the Chick Anxiety- ...

Herbal medicines and botanicals for managing insomnia ...

Sceletium Tortuosum (Zembrin®) ameliorates experimentally induced anxiety in healthy volunteers. Hum. Psychopharmacol. Clin. Exp., 35 (2020), pp. 1-7.

What Is Kanna — and Can It Really Reduce My Anxiety?

Kanna, a medicinal plant with a lengthy history of uses and benefits, including reduced anxiety, elevated mood, and better sleep and brain health.

Sceletium tortuosum: A review on its phytochemistry, ...

Of the 15 non-toxic extracts tested, the Sceletium tortuosum water extract exhibited the most promising anxiolytic activity.Conclusions The ...

Kanna: Uses and safety in dietary supplements

Sceletium tortuosum (Zembrin®) ameliorates experimentally induced anxiety in healthy volunteers. Human Psychopharmacology: Clinical and Experimental, 35(6) ...

Sceletium: Uses, Side Effects, Interactions, Pictures, ...

Note: The FDA has not reviewed sceletium for safety and effectiveness, and it is not approved by the FDA. Learn more about dietary supplements ...

Efficacy, Safety, Quality Control, Marketing and Regulatory ...

Here's a summary of the findings with highlighted doses of Zembrin®, a branded ST extract: Reduced Anxiety Response: A single 25 mg dose. ( ...