Ignite Creation Date:
2024-07-17 @ 11:20 AM
Last Modification Date:
2024-10-26 @ 3:32 PM
Study NCT ID:
NCT06463145
Status:
COMPLETED
Last Update Posted:
2024-07-01
First Post:
2024-06-12
Brief Title:
Study of the Anxiolytic Effects of Aframomum Seed Extract in Elderly People
Sponsor:
Nektium Pharma SL
Organization:
Nektium Pharma SL
Study Overview
Official Title:
Effects of a Plant Extract Modulating the Endocannabinoid System and Its Anxiolytic Capacity on Elderly People in Situations of Stress or Anxiety
Status:
COMPLETED
Status Verified Date:
2024-06
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief 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 extracts 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 50100 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 2for checkups and tests
Keep a diary with questions about their activities daily foods and physicals perceptions
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 50100 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 2for checkups and tests
Keep a diary with questions about their activities daily foods and physicals perceptions
Detailed Description:
The present randomized double-blind placebo-controlled crossover trial aims to evaluate the effects of standardized aframomum melegueta seed extract AME supplementation on anxiety mood and sleep quality in healthy men and women experiencing anxious situations A total of 37 participants were randomly assigned to either AME-first groups or placebo-first group participants were taken 50 100 or 150 mg of either AME or matched placebo peels daily for three days This period is followed by a 1 week washout period at the beginning of which all participants will stop the assigned intervention After this washout the participants will start their crossover intervention All Participants were instructed to follow a standardized training program throughout the study including washout periods to maintain uniformity in physical activity and reduce the effect that exercise can have on stress management The effects of supplement AME doses compared with a placebo were evaluated using measures to assess anxiety The Hamilton Anxiety Scale HAM-A mood Adapted Profile Mood State POMS sleep quality Sleep Evaluation Questionnaire LSEQ and Pittsburgh Sleep Quality Index PSQI In addition some physiological Blood pressure and heart rate variability biochemical minerals hepatic enzymes and inflammatory biomarkers and hematological variables Complete cell count were determined Testing was completed at the beginning Day0 and at the end Day2 of the supplementation periods with the extract and placebo products to assess acute effects following 3 days of daily use
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None