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Study of the Anxiolytic Effects of Aframomum Seed Extract in Elderly People

NCT06463145 · Status: COMPLETED · Phase: NA · Type: INTERVENTIONAL · Enrollment: 37

Last updated 2024-07-01

No results posted yet for this study

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.

Conditions

  • Situational Anxiety

Interventions

DIETARY_SUPPLEMENT

Vanizem

Aframomum melegueta seed extract standardized to 10% of total Vanilloid and at least 1.5% of 6-paradol

DIETARY_SUPPLEMENT

Placebo

Food grade Maltodextrin 12

Sponsors & Collaborators

  • Kinetic performance

    collaborator UNKNOWN

  • Nektium Pharma SL

    lead INDUSTRY

Principal Investigators

  • Laura López-Rios, PhD · Nektium Pharma SL

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
QUADRUPLE
Model
CROSSOVER

Eligibility

Min Age
40 Years
Max Age
50 Years
Sex
ALL
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2023-03-01
Primary Completion
2023-04-12
Completion
2023-05-20

Countries

  • Spain

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT06463145 on ClinicalTrials.gov