Status:
COMPLETED
Effect of a Botanical Ingredient in Healthy Subjects With Anxiety and Poor Sleep Quality
Lead Sponsor:
Universidad Católica San Antonio de Murcia
Conditions:
Poor Quality Sleep
Eligibility:
All Genders
18-65 years
Phase:
NA
Brief Summary
Randomized, controlled, double-blind, single-center clinical trial with two parallel arms depending on the product consumed (experimental product and placebo product) to analyze the efficacy of a bota...
Detailed Description
Subjects who meet the selection criteria will be randomly assigned to each of the study groups (investigational product dose or placebo, depending on the group to which they have been assigned). The ...
Eligibility Criteria
Inclusion
- Healthy adults.
- Moderate levels of anxiety by STAI.
- Low sleep quality by PSQI.
- Volunteers able to understand the clinical study and willing to comply with its procedures and requirements.
Exclusion
- Serious or terminal illness.
- Subjects with body mass index above 32 kg/m2. Pregnant or lactating women.
- Participation in another study involving blood draws or dietary intervention.
- Organic dementias such as Alzheimer's, Huntington's disease, Parkinson's and senile dementia.
- Hypersensitivity to the components of the formula.
- Use of medications that alter cognitive functions or sleep, such as barbiturates, anticonvulsants, benzodiazepines, antidepressants, neuroleptics, alcohol and illicit drugs.
- Subjects with known allergy to some of the study components.
- Inability to understand the informed consent.
Key Trial Info
Start Date :
September 15 2023
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
January 29 2024
Estimated Enrollment :
79 Patients enrolled
Trial Details
Trial ID
NCT06154629
Start Date
September 15 2023
End Date
January 29 2024
Last Update
February 16 2024
Active Locations (1)
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1
Catholic University of Murcia
Murcia, Spain, 30107