NCT04368169

Brief Summary

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
71

participants targeted

Target at P50-P75 for not_applicable

Timeline
Completed

Started Apr 2020

Shorter than P25 for not_applicable

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

April 27, 2020

Completed
Same day until next milestone

Study Start

First participant enrolled

April 27, 2020

Completed
2 days until next milestone

First Posted

Study publicly available on registry

April 29, 2020

Completed
5 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

September 30, 2020

Completed
2 months until next milestone

Study Completion

Last participant's last visit for all outcomes

November 30, 2020

Completed
Last Updated

February 26, 2021

Status Verified

February 1, 2021

Enrollment Period

5 months

First QC Date

April 27, 2020

Last Update Submit

February 25, 2021

Conditions

Respiratory Health

Outcome Measures

Primary Outcomes (1)

  • Change from baseline on the 44-part Wisconsin Upper Respiratory Symptom Survey (WURSS-44) at day 3.

    The Wisconsin Upper Respiratory Symptom Survey (WURSS-44) is a validated, self reported instrument assessing overall respiratory health. Possible scores range from 0 to 308 with lower scores indicating fewer respiratory complaints.

    Baseline and Day 3

Study Arms (2)

Aromatic Extract

EXPERIMENTAL

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

Dietary Supplement: Teramune Botanical Extract

Placebo

PLACEBO COMPARATOR

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

Other: Placebo

Interventions

Teramune Botanical ExtractDIETARY_SUPPLEMENT

Combination blend of aromatic plant extracts in an emulsifier carrier.

Aromatic Extract
PlaceboOTHER

Emulsifier carrier without active supplement ingredients.

Placebo

Eligibility Criteria

Age18 Years - 60 Years
Sexfemale(Gender-based eligibility)
Gender Eligibility Detailsself identify as female
Healthy VolunteersYes
Age GroupsAdult (18-64)

You may qualify if:

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

You may not qualify if:

  • underlying respiratory conditions
  • pregnant, breastfeeding, or trying to conceive
  • tobacco use in the home
  • allergies to any of the ingredients

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Franklin School of Integrative Health Sciences

Franklin, Tennessee, 37067, United States

Location

Study Officials

  • Jessie H Hawkins, PhD

    Nutraceuticals Research Institute

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
DOUBLE
Who Masked
PARTICIPANT, CARE PROVIDER
Masking Details
Double Blind
Purpose
SUPPORTIVE CARE
Intervention Model
PARALLEL
Model Details: Participants are recruited through a single health practice and randomized through block randomization to one of 2 groups: botanical extract or inert control.
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

April 27, 2020

First Posted

April 29, 2020

Study Start

April 27, 2020

Primary Completion

September 30, 2020

Study Completion

November 30, 2020

Last Updated

February 26, 2021

Record last verified: 2021-02

Data Sharing

IPD Sharing
Will not share

Locations

US(1)