The Effects of an Aromatic Botanical Extract on Respiratory Health.

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.

Study Overview

• Status: Completed
• Conditions: Respiratory Health
• Intervention / Treatment: Dietary supplement: Teramune Botanical Extract; Other: Placebo

Detailed Description

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.

• Study Type: Interventional
• Enrollment (Actual): 71
• Phase: Not Applicable

Contacts and Locations

Study Locations

• United States
  • Tennessee
    • Franklin, Tennessee, United States, 37067
      • Franklin School of Integrative Health Sciences

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 60 years (Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: Female

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Supportive Care
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Double

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Aromatic Extract; Participants receive the aromatic botanical extract orally every 4-6 waking hours for 3 days.	Dietary supplement: Teramune Botanical Extract; Combination blend of aromatic plant extracts in an emulsifier carrier.
Placebo Comparator: Placebo; Participants receive the placebo matching the botanical extract orally every 4-6 waking hours for 3 days.	Other: Placebo; Emulsifier carrier without active supplement ingredients.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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

Collaborators and Investigators

• Sponsor: Franklin Health Research
• Investigators: Principal Investigator: Jessie H Hawkins, PhD, Franklin Health Research

Study record dates

Study Major Dates

• Study Start (Actual): April 27, 2020
• Primary Completion (Actual): September 30, 2020
• Study Completion (Actual): November 30, 2020

Study Registration Dates

• First Submitted: April 27, 2020
• First Submitted That Met QC Criteria: April 27, 2020
• First Posted (Actual): April 29, 2020

Study Record Updates

• Last Update Posted (Actual): February 26, 2021
• Last Update Submitted That Met QC Criteria: February 25, 2021
• Last Verified: February 1, 2021

More Information

Terms related to this study

• Other Study ID Numbers: 20-4-9100

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: No

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No