Evaluations, Diagnostic SelfNCT06672965
A Clinical Study to Evaluate the Efficacy of Dietary Supplement to Alleviate Stress Versus Placebo in Subjects with Mild to Moderate Levels of Stress
A study testing anti-stress supplement in people with Evaluations, Diagnostic Self, run by Pharmanex at 1 site in United Kingdom.
Trial 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 Read more about this study
- Who is it for?
- Ages 40 to 45 yearsHealthy volunteers can take part
- Conditions the study is for
- Evaluations, Diagnostic Self
- What is being tested?
- anti-stress supplement
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 60 participants
- Where
- 1 siteUnited Kingdom
- Study dates
- 19 Jun 2023to 30 Jul 2023
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 40 to 45 years
- All sexes
- Healthy volunteers accepted
- Adult
Who may be able to join
- 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.
Who cannot join
- 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.
- Having taken dietary supplements within the last 3 months to help relieve sleep disturbances or physiological stress.
- Having taken anti-depressants/anti-anxiety/mood enhancing/ recreational drugs (e.g., marijuana) within 6 months prior to screening.
- Having smoked, vaped, or used recreational drugs (e.g., marijuana, THC, CBD) within the last 6 months prior to screening.
- Having any known chronic skin conditions that may be exacerbated with using a topical product.
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- Pregnant, planning to become pregnant or nursing.
- Any known allergy or intolerance to any of the ingredients contained in supplements or topical product.
- Individuals with sunburn, moderate to pronounced suntan, uneven skin tones, tattoos, scars or other disfiguration, dilated vessels or other conditions on the test area that might influence the test results.
- Any disease or condition of the skin that the examining investigator deems inappropriate for participation, including rosacea, eczema, and atopic dermatitis.
- Individuals currently taking certain medications which in the opinion of the investigators may interfere with the Study. This would include but not be limited to routine high dosage use of anti-inflammatory drugs (aspirin, ibuprofen, corticosteroids) immunosuppressive drugs or antihistamine medications (steroid nose drops and/or eye drops are permitted), and insulin, antihypertensive drugs, antibiotics, or other topical drugs at the test sites.
- Individuals who have routinely used an alpha-hydroxy-acid (AHA) or a betahydroxy-acid (BHA) containing product within two weeks or Retin-A®, Retin-A Micro®, Renovar®, Differin®, Avita®, Tazorac®, or Soriatane® within one month of the Study start or have taken Accutane® within one year of the Study start.
- Individuals who have used Retinol in the last six months.
- Individuals with inflammatory acne lesions (i.e., papules, pustules, cysts, nodules) at the test site.
- Individuals with known allergies to skin treatment products or cosmetics, toiletries, and/or topical.
- Individuals taking high dose biotin (i.e., >5 mg / > 5000 μg per day).
- Individuals who work night shifts.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: 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
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
- Conditions
- Evaluations, Diagnostic Self
- Being tested
- anti-stress supplement, Placebo
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
anti-stress supplementDietary supplement
The anti-stress supplement was developed to provide relief from anxiety and depression levels.Subjects were given 60 capsules of calming supplement (30-day supply) and instructed to take two capsules each day orally with water.
PlaceboDietary supplement
Subjects were given 60 capsules of placebo (30-day supply) and instructed to take two capsules each day orally with water.
| Study group | Role | What they receive |
|---|---|---|
| Placebo | Placebo comparator | Placebo was prepared as a capsule composed of excipients only (stearic acid and natural caramel color to match the mg weight of the combination supplement capsule). Take two (2) capsules daily with water. Receives: Dietary Supplement: Placebo |
| Calming supplement | Active comparator | The combination supplement was prepared to deliver 600 mg of Lemon Balm extract, 100 mg of Magnolia Bark extract (containing 40 mg of honokiol) and 200 mg L-theanine daily in 2 capsules with water. Receives: Dietary Supplement: anti-stress supplement |
What is being measured
The primary outcome is the main question the study is designed to answer.
Assessment of anxiety using Hamilton Anxiety Rating Scale (HAM-A) scale
Hamilton Anxiety Rating Scale (HAM-A) (1) was assessed using a questionnaire and scored on a scale of 0 to 4, with 0 (no presence of anxiety) to 4 (severe anxiety). (1) Hamilton, M. The assessment of anxiety states by rating. Br. J. Med. Psychol. 1959, 32, 50-55.
Measured: 30 days
Assessment of depression using Hamilton Depression Rating Scale (HDRS) scale
Hamilton Depression Rating Scale (HDRS) (1) was assessed using a questionnaire and scored using a scale of 0 to 20, with 0-7 (within normal range or remission) while a score of 20 (indicating moderate depression.
(1) Hamilton, M. A rating scale of depression. J. Neurol. Neurosurg. Psychiatry, 1960, 23, 56-62.
Measured: 30 days
Assessment of perception of stress in subjects that experience moderate levels of stress using Perceived Stress Scale (PSS)
Perceived stress was assessed with Perceived Stress Scale (PSS) using a validated questionnaire on a score of 0 to 40, with 0 (no stress) and 20 or above (higher perceived stress) at day 1, day 7 and at day 30.
Measured: 30 days
Secondary outcomes (2)
Assessment of mood using Profile of Mood States (POMS) scale
Assessment of Profile of Mood States (POMS) was measured on a 5 point scale of 0 to 5, with 0 (not at all moody) to 4 (extremely moody),
Measured: 30 days
Assessment of sleep using Restorative Sleep Questionnaire, Weekly (RSQ-W) version scale
Restorative Sleep Questionnaire, Weekly (RSQ-W) is a nine-item survey that measures how restful a person feels after sleeping for the past week. The RSQ-W scale scores range from 0-100, with higher scores indicating more restorative sleep. To convert the average score to a 0-100 scale, use the formula: RSQ-W Total Score = {RSQ-W Average Score Across Completed Items - 1.0}*25.
Measured: 30 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted4 Nov 2024
- Study start19 Jun 2023
- Primary completion20 Jul 2023
- Study completion30 Jul 2023
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Evaluations, Diagnostic SelfStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind
- Who is masked
- Participant, Investigator, Outcomes assessor
- Enrolment
- 60 participants (actual)
Sponsor and investigators
- Lead sponsor
- Pharmanex
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06672965
- Sponsor's protocol ID
- RIGCLI22M
- Status last verified
- Sep 2024
- First submitted
- 21 Oct 2024
- Last updated
- 4 Nov 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 4 Nov 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- 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
- ClinicalTrials.gov ID
- NCT06672965
- Acronym / sponsor ID
- RIGCLI22M
- Conditions
- Evaluations, Diagnostic Self
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 60 participants (actual)
- Lead sponsor
- PharmanexIndustry (pharma, biotech, devices)
- Study start
- 19 Jun 2023 (actual)
- Primary completion
- 20 Jul 2023 (actual)
- Study completion
- 30 Jul 2023 (actual)
- First posted
- 4 Nov 2024 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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
Study design
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind (participant, investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Placebo | Placebo comparator | Dietary Supplement: PlaceboPlacebo was prepared as a capsule composed of excipients only (stearic acid and natural caramel color to match the mg weight of the combination supplement capsule). Take two (2) capsules daily with water. |
| Calming supplement | Active comparator | Dietary Supplement: anti-stress supplementThe combination supplement was prepared to deliver 600 mg of Lemon Balm extract, 100 mg of Magnolia Bark extract (containing 40 mg of honokiol) and 200 mg L-theanine daily in 2 capsules with water. |
Who may qualify
- Ages
- 40 to 45 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (8 listed)
- 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.
Key exclusion criteria (17 listed)
- 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.
- Having taken dietary supplements within the last 3 months to help relieve sleep disturbances or physiological stress.
- Having taken anti-depressants/anti-anxiety/mood enhancing/ recreational drugs (e.g., marijuana) within 6 months prior to screening.
- Having smoked, vaped, or used recreational drugs (e.g., marijuana, THC, CBD) within the last 6 months prior to screening.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| anti-stress supplementThe anti-stress supplement was developed to provide relief from anxiety and depression levels.Subjects were given 60 capsules of calming supplement (30-day supply) and instructed to take two capsules each day orally with water. | Dietary supplement | Calming supplement |
| PlaceboSubjects were given 60 capsules of placebo (30-day supply) and instructed to take two capsules each day orally with water. | Dietary supplement | Placebo |
Primary outcome
Assessment of anxiety using Hamilton Anxiety Rating Scale (HAM-A) scale
Time frame: 30 days
Hamilton Anxiety Rating Scale (HAM-A) (1) was assessed using a questionnaire and scored on a scale of 0 to 4, with 0 (no presence of anxiety) to 4 (severe anxiety). (1) Hamilton, M. The assessment of anxiety states by rating. Br. J. Med. Psychol. 1959, 32, 50-55.
Assessment of depression using Hamilton Depression Rating Scale (HDRS) scale
Time frame: 30 days
Hamilton Depression Rating Scale (HDRS) (1) was assessed using a questionnaire and scored using a scale of 0 to 20, with 0-7 (within normal range or remission) while a score of 20 (indicating moderate depression. (1) Hamilton, M. A rating scale of depression. J. Neurol. Neurosurg. Psychiatry, 1960, 23, 56-62.
Assessment of perception of stress in subjects that experience moderate levels of stress using Perceived Stress Scale (PSS)
Time frame: 30 days
Perceived stress was assessed with Perceived Stress Scale (PSS) using a validated questionnaire on a score of 0 to 40, with 0 (no stress) and 20 or above (higher perceived stress) at day 1, day 7 and at day 30.
2 secondary outcomes
Assessment of mood using Profile of Mood States (POMS) scale
Time frame: 30 days
Assessment of sleep using Restorative Sleep Questionnaire, Weekly (RSQ-W) version scale
Time frame: 30 days
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 4 Nov 2024.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing anti-stress supplement in people with Evaluations, Diagnostic Self, run by Pharmanex at 1 site in United Kingdom.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 8 inclusion and 17 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 4 Nov 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United Kingdom. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Assessment of anxiety using Hamilton Anxiety Rating Scale (HAM-A) scale (time frame: 30 days). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 4 Nov 2024.