Effect of a Botanical Ingredient in Healthy Subjects With Anxiety and Poor Sleep Quality (NCT06154629) | Clinical Trial Compass
CompletedNot Applicable
Effect of a Botanical Ingredient in Healthy Subjects With Anxiety and Poor Sleep Quality
Spain79 participantsStarted 2023-09-15
Plain-language 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 botanical extract in reducing anxiety and improving sleep quality.
Who can participate
Age range
18 Years – 65 Years
Sex
ALL
See this in plain English?
AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
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.
Questions worth asking your doctor
Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.
1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?
Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.
Questions for the trial coordinator
The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.
1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?
A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.
What they're measuring
1
Variation in sleep quality from baseline at 12 weeks.
Timeframe: The evolution of sleep quality after consumption during 12 weeks will be measured.