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:
2025-12-25 @ 3:37 AM
Ignite Modification Date:
2025-12-25 @ 3:37 AM
NCT ID:
NCT01299402
Eligibility Criteria:
Inclusion Criteria:
* Healthy men and women between the ages of 21-65.
* No concerns that would confound the study as determined by study physicians.
* Women must not be pregnant or become pregnant for the duration of the study.
Exclusion Criteria:
* The subject has a history of hypersensitivity to any of the compounds used in the study
* The subject is pregnant or breast feeding. Note: If the potential subject is a post-menarche female, a urine pregnancy test must be performed within 24 hours prior to study drug administration and confirmed negative in order for the potential subject to eb enrolled.
* History of Psychiatric Illness or Chronic Stress or Anxiety
* Hypertension, cardiovascular disease, liver, hypokalemia, or kidney disease or other health concerns that the study physician feels may confound study results
* Individuals who are cognitively impaired or who are not able to give informed consent
* Any routine prescription medication that the study physician feels may cause drug interaction with Soulera or alter the prescription medications' activity
* Previous participation in a clinical research trial within 30 days prior to randomization
* The subject has an ongoing abuse of illicit substances, alcohol, or actively smoking marijuana
* The subject uses or has used in the past 30 days any steroid formulation, be it topical like face cream, ocular as in an eye drop, nasal as in a spray, injection or pill.
* The subject is a current smoker or uses tobacco products such as chewing tobacco.
* The subject is actively engaging in the use of Herbal Medicine, Traditional Chinese Medicine, Ancient Indian Medicine, Yoga, or Ayurveda
* The subject is a night-shift worker and therefore presumably has an altered cortisol diurnal rhythm and is also unable to comply with the required cortisol collection times of the study
Healthy Volunteers:
True
Sex:
ALL
Minimum Age:
21 Years
Maximum Age:
65 Years
Study:
NCT01299402
Study Brief:
Protocol Section:
NCT01299402