The Effects of an Aromatic Botanical Extract on Respiratory Health.

• Sponsor: Franklin Health Research (Other)
• Overall Status: Completed
• CT.gov ID: NCT04368169
• Collaborator: (none)
• Enrollment: 71
• Location: 1
• Arms: 2
• Actual Duration (Months): 7.1
• Patients Per Site Per Month: 10

Study Details

Study Description

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.

Condition or Disease	Intervention/Treatment	Phase
Respiratory Health	Dietary Supplement: Teramune Botanical Extract; Other: Placebo	N/A

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 Design

• Study Type: Interventional
• Actual Enrollment: 71 participants
• Allocation: Randomized
• Intervention Model: Parallel Assignment
• Intervention Model Description: Participants are recruited through a single health practice and randomized through block randomization to one of 2 groups: botanical extract or inert control.Participants are recruited through a single health practice and randomized through block randomization to one of 2 groups: botanical extract or inert control.
• Masking: Double (Participant, Care Provider)
• Masking Description: Double Blind
• Primary Purpose: Supportive Care
• Official Title: The Effects of an Aromatic Botanical Extract on Respiratory Health.
• Actual Study Start Date: Apr 27, 2020
• Actual Primary Completion Date: Sep 30, 2020
• Actual Study Completion Date: Nov 30, 2020

Arms and Interventions

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.

Outcome Measures

Primary Outcome Measures

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

Eligibility Criteria

Criteria

• Ages Eligible for Study: 18 Years to 60 Years
• Sexes Eligible for Study: Female
• Accepts Healthy Volunteers: Yes

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

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Franklin School of Integrative Health Sciences	Franklin	Tennessee	United States	37067

Sponsors and Collaborators

• Franklin Health Research

Investigators

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

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

• Responsible Party: Franklin Health Research
• ClinicalTrials.gov Identifier: NCT04368169
• Other Study ID Numbers: 20-4-9100
• First Posted: Apr 29, 2020
• Last Update Posted: Feb 26, 2021
• Last Verified: Feb 1, 2021

• Individual Participant Data (IPD) Sharing Statement: No
• Plan to Share IPD: No
• Studies a U.S. FDA-regulated Drug Product: No
• Studies a U.S. FDA-regulated Device Product: No

Study Results

No Results Posted as of Feb 26, 2021