The Effects of an Aromatic Botanical Extract on Respiratory Health.

NCT ID: NCT04368169

Last Updated: 2021-02-26

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

71 participants

Study Classification

INTERVENTIONAL

Study Start Date

2020-04-27

Study Completion Date

2020-11-30

Brief Summary

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This study is a randomized, double blind, placebo controlled, intervention study evaluating the effect of an aromatic botanical extract on overall respiratory health among otherwise healthy adults.

Detailed Description

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After being informed about the study and providing informed consent, patients with respiratory complaints will be randomized into a double blind placebo controlled trial of the botanical extract.

Conditions

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Respiratory Health

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Participants are recruited through a single health practice and randomized through block randomization to one of 2 groups: botanical extract or inert control.
Primary Study Purpose

SUPPORTIVE_CARE

Blinding Strategy

DOUBLE

Participants Caregivers
Double Blind

Study Groups

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Aromatic Extract

Participants receive the aromatic botanical extract orally every 4-6 waking hours for 3 days.

Group Type EXPERIMENTAL

Teramune Botanical Extract

Intervention Type DIETARY_SUPPLEMENT

Combination blend of aromatic plant extracts in an emulsifier carrier.

Placebo

Participants receive the placebo matching the botanical extract orally every 4-6 waking hours for 3 days.

Group Type PLACEBO_COMPARATOR

Placebo

Intervention Type OTHER

Emulsifier carrier without active supplement ingredients.

Interventions

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Teramune Botanical Extract

Combination blend of aromatic plant extracts in an emulsifier carrier.

Intervention Type DIETARY_SUPPLEMENT

Placebo

Emulsifier carrier without active supplement ingredients.

Intervention Type OTHER

Eligibility Criteria

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Inclusion Criteria

* age: 18-60 years
* currently experiencing respiratory symptoms
* otherwise healthy

Exclusion Criteria

* underlying respiratory conditions
* pregnant, breastfeeding, or trying to conceive
* tobacco use in the home
* allergies to any of the ingredients
Minimum Eligible Age

18 Years

Maximum Eligible Age

60 Years

Eligible Sex

FEMALE

Accepts Healthy Volunteers

Yes

Sponsors

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Nutraceuticals Research Institute

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Jessie H Hawkins, PhD

Role: PRINCIPAL_INVESTIGATOR

Nutraceuticals Research Institute

Locations

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Franklin School of Integrative Health Sciences

Franklin, Tennessee, United States

Site Status

Countries

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United States

Other Identifiers

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20-4-9100

Identifier Type: -

Identifier Source: org_study_id

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