The Effects of an Aromatic Botanical Extract on Respiratory Health.

Respiratory Health Clinical Trial

Official title:

The Effects of an Aromatic Botanical Extract on Respiratory Health.

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT04368169
• Other study ID #: 20-4-9100
• Status: Completed
• Phase: N/A
• Start date: April 27, 2020
• Est. completion date: November 30, 2020

Study information

• Verified date: February 2021
• Source: Franklin School of Integrative Health Sciences
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 71
• Est. completion date: November 30, 2020
• Est. primary completion date: September 30, 2020
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Female
• Age group: 18 Years to 60 Years

Eligibility

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

Related Conditions & MeSH terms

• Respiratory Health

Intervention

Dietary Supplement:
• Teramune Botanical Extract
Combination blend of aromatic plant extracts in an emulsifier carrier.

Other:
• Placebo
Emulsifier carrier without active supplement ingredients.

Locations

Country	Name	City	State
United States	Franklin School of Integrative Health Sciences	Franklin	Tennessee

Sponsors (1)

Lead Sponsor	Collaborator
Franklin School of Integrative Health Sciences

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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