CompletedNot Applicable

A Clinical Study to Evaluate the Efficacy of Dietary Supplement to Alleviate Stress Versus Placebo in Subjects with Mild to Moderate Levels of Stress

United Kingdom60 participantsStarted 2023-06-19

Plain-language summary

A single centre, double blind, placebo-controlled clinical study design in healthy subjects to evaluate the efficacy of dietary supplement to alleviate stress in subjects with mild to moderate stress

Who can participate

Age range

40 Years – 45 Years

Sex

ALL

See this in plain English?

AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

Inclusion criteria

. Must complete pre-study assessment questionnaire and have a minimum stress level score of ≥14.
. The subject is a healthy male or female 25-55 years of age at the time of informed consent.
. The subject must have a BMI of ≥18.5 and ≤30.0 kg/m2 and be willing to have their height and weight measured.
. No reported history of psychological or mental disorders.
. Free of anti-depressants/anti-anxiety/mood enhancing/recreational drugs (e.g., marijuana, THC, CBD) intake for at least 6 months prior to screening.
. Free of any 'over the counter' or prescribed medications except for female participants taking contraceptive pills.
. Agree to abstain from smoking, vaping, or using recreation drugs (e.g., marijuana, THC, CBD) during the study.
. Willing and able to give informed consent.

Exclusion criteria

. Resting systolic blood pressure above 140 mmHg or a diastolic blood pressure above 90 mmHg at baseline visit.
. Having taken pharmaceutical products within the last 3 months to help to relieve sleep disturbances or physiological stress.

Questions worth asking your doctor

Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.

1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?

Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.

Questions for the trial coordinator

The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.

1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?

A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.

What they're measuring

Assessment of anxiety using Hamilton Anxiety Rating Scale (HAM-A) scale

Timeframe: 30 days

Assessment of depression using Hamilton Depression Rating Scale (HDRS) scale

Timeframe: 30 days

Assessment of perception of stress in subjects that experience moderate levels of stress using Perceived Stress Scale (PSS)

Timeframe: 30 days

Trial details

NCT IDNCT06672965

SponsorPharmanex

Sponsor typeINDUSTRY

Study typeINTERVENTIONAL

Primary completion2023-07-20

View on ClinicalTrials.gov More Evaluations, Diagnostic Self trials

Who can participate

Age range

40 Years – 45 Years

Sex

ALL

See this in plain English?

AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

Inclusion criteria

. Must complete pre-study assessment questionnaire and have a minimum stress level score of ≥14.
. The subject is a healthy male or female 25-55 years of age at the time of informed consent.
. The subject must have a BMI of ≥18.5 and ≤30.0 kg/m2 and be willing to have their height and weight measured.
. No reported history of psychological or mental disorders.
. Free of anti-depressants/anti-anxiety/mood enhancing/recreational drugs (e.g., marijuana, THC, CBD) intake for at least 6 months prior to screening.
. Free of any 'over the counter' or prescribed medications except for female participants taking contraceptive pills.
. Agree to abstain from smoking, vaping, or using recreation drugs (e.g., marijuana, THC, CBD) during the study.
. Willing and able to give informed consent.

Exclusion criteria

. Resting systolic blood pressure above 140 mmHg or a diastolic blood pressure above 90 mmHg at baseline visit.
. Having taken pharmaceutical products within the last 3 months to help to relieve sleep disturbances or physiological stress.

What they're measuring

Assessment of anxiety using Hamilton Anxiety Rating Scale (HAM-A) scale

Timeframe: 30 days

Assessment of depression using Hamilton Depression Rating Scale (HDRS) scale

Timeframe: 30 days

Assessment of perception of stress in subjects that experience moderate levels of stress using Perceived Stress Scale (PSS)

Timeframe: 30 days