Eligibility Module
The Eligibility Module contains detailed information about who can participate in the clinical trial. This includes eligibility criteria, age restrictions, gender requirements, healthy volunteer status, and study population descriptions, helping researchers understand who is eligible to participate in the study.
Eligibility Module path is as follows:
Study -> Protocol Section -> Eligibility Module
Eligibility Module
Ignite Creation Date:
2025-12-24 @ 4:02 PM
Ignite Modification Date:
2025-12-24 @ 4:02 PM
NCT ID:
NCT05232266
Eligibility Criteria:
Inclusion Criteria:
* Adults aged 18 years and above
* Self-reporting Stress
* Able to provide informed consent
* Agree not to change current diet and exercise program while enrolled in this trial
* Agree not to undertake another clinical trial while enrolled in this trial
Exclusion Criteria:
* Unstable or serious illness (e.g. Serious mood disorders, neurological disorders such as MS, kidney disease, liver disease, heart conditions, diabetes, thyroid gland dysfunction)\*
* Current malignancy (excluding BCC) or chemotherapy and radiotherapy treatment for malignancy within the previous 2 years
* Receiving/prescribed coumadin (Warfarin), heparin, dalteparin, enoxaparin or other anticoagulation therapy
* Receiving treatment for anxiety, or taking supplements# for anxiety or sleep conditions such as saffron, valerian, etc.
* Active smokers, nicotine use, alcohol or drug (prescription or illegal substances) abuse
* Chronic past and/or current alcohol use (\>14 alcoholic drinks week)
* Allergic to any of the ingredients in the active or placebo formula
* Known pregnant or lactating woman
* Any condition which in the opinion of the investigator makes the participant unsuitable for inclusion
* Participants who have participated in any other related clinical study during the past 1 month
* History of infection in the month prior to the study
* An unstable illness is any illness that is currently not being treated with a stable dose of medication or is fluctuating in severity. A serious illness is a condition that carries a risk of mortality, negatively impacts quality of life and daily function and/or is burdensome in symptoms and/or treatments.
* Potential participants that are taking supplements that would result in their exclusion must wait a 4-week washout period prior to commencing the study.
Healthy Volunteers:
True
Sex:
ALL
Minimum Age:
18 Years
Study:
NCT05232266
Study Brief:
Protocol Section:
NCT05232266