Study of the Anxiolytic Effects of Aframomum Seed Extract in Elderly People (NCT06463145) | Clinical Trial Compass
CompletedNot Applicable
Study of the Anxiolytic Effects of Aframomum Seed Extract in Elderly People
Spain37 participantsStarted 2023-03-01
Plain-language summary
The goal of this pilot clinical trial is to evaluate if one specific botanical extract from Grains of Paradise works to induce anxiolytic effect in adult people in stress or anxiety situations It will also learn about the extract's positive effects on sleep and mood. The main questions it aims to answer are:
Does botanical extract exert an anxiolytic effect on the participants under stress or anxiety circumstances? Does botanical extract promote positive effects on Mood and nocturnal sleep? Does botanical extract influence body parameters like Blood pressure, inflammatory indicators or stress hormones? Researchers will compare tree doses of botanical extract (50,100 or 150mg) to a placebo (a look-alike substance that contains no herbal product) to see if herbal extract support anxiolytic effect.
Participants will:
Take herbal extract or a placebo daily for 3 days. Visit the clinic two times: at the start of the study (day0) and to the end of the study (Day +2)for checkups and tests.
Keep a diary with questions about their activities, daily foods and physicals perceptions.
Who can participate
Age range
40 Years – 50 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:
* Male or female between 40 and 50 year of age;
* Healthy people with moderate anxiety: HAM-A score in a range between 18 and 24;
* Subject able and willing to participate to the study by complying with the protocol procedures as confirmed by his dated and signed informed consent form;
Exclusion Criteria:
* Score greater than 20 points on the Hamilton Depression Rating Scale (HDRS);
* Receiving medical treatment for anxiety, stress or depression;
* Drugs and alcohol dependence;
* Serious personality disorders that may interfere with participation in the study (psychosis, intense suicidal ideation, etc.);
* In the case of women, having the intention of becoming pregnant;
* Epileptic disorders;
* Liver disorders (cirrhosis, hepatitis, etc.);
* Professional athletes or those who frequently engage in extreme physical activities;
* Impossibility of completing the intervention period due to external factors;
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
Change in Hamilton Anxiety Rating Scale (HAM-A) score
Timeframe: At baseline (day 0) and after intake period (day 2+)