Effect of a Botanical Ingredient in Healthy Subjects With Anxiety and Poor Sleep Quality (Q-Sleep)

Universidad Católica San Antonio de Murcia

Status: Completed

Conditions: Poor Quality Sleep

Treatments: Dietary Supplement: Control group; Dietary Supplement: Botanical ingredient

Study type: Interventional

Funder types: Other

Identifiers

NCT06154629

UCAMCFE-00034

Details and patient eligibility

About

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 botanical extract in reducing anxiety and improving sleep quality.

Full 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 product to be consumed is a botanical extract. Participants will consume the product for 90 days. They should consume one capsule one hour before going to sleep.

They will make a total of five visits to the research laboratory and the tests preestablished in the protocol will be performed. Subsequently, a statistical analysis will be performed with the variables measured in the study to obtain the results.

Enrollment: 79 patients

Sex: All

Ages: 18 to 65 years old

Volunteers: Accepts Healthy Volunteers

Inclusion criteria

• 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 criteria

• 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.

Trial design

Primary purpose: Other

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Quadruple Blind

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79 participants in 2 patient groups, including a placebo group

Botanical ingredient

Experimental group

Description:

Consumption for 90 days. Subjects should consume one capsule one hour before going to sleep

Treatment:

Dietary Supplement: Botanical ingredient

Control Group

Placebo Comparator group

Description:

Consumption for 90 days. Subjects should consume one capsule one hour before going to sleep

Treatment:

Dietary Supplement: Control group