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 @ 3:06 PM
Ignite Modification Date:
2025-12-24 @ 3:06 PM
NCT ID:
NCT05023759
Eligibility Criteria:
Inclusion Criteria:
* Age between 21 and 85 years old.
* Research participants of both sexes.
* Good health conditions and without conditions that characterize them as belonging to the risk groups associated with adverse reactions to the product ingredients.
* Research participants with the potential to become pregnant may be included in the study as long as they are sexually abstinent or using a contraceptive method considered effective.
* Signature of the Free and Informed Consent Form.
Exclusion Criteria:
* Initiation of or changes in use of medication or therapies in the past 2 weeks of start of study.
* Pregnancy or breastfeeding.
* History of hepatic compromise with transaminases of 2 times the upper limit of normal or cirrhosis.
* Diagnosis of Bi-Polar disorder, Schizophrenia or Suicidal Ideation.
* Current use of recreational marijuana, medical marijuana, or other CBD formulations.
* History of any substance or alcohol abuse.
* Current use of High Dose or Extended-Release Narcotics.
* Patients diagnosed with sleep apnea.
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
21 Years
Maximum Age:
85 Years
Study:
NCT05023759
Study Brief:
Protocol Section:
NCT05023759