The Effects of an Aromatic Botanical Extract on Respiratory Health.

Overview

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 Type

  • Study Type: Interventional
  • Study Design
    • Allocation: Randomized
    • Intervention Model: Parallel Assignment
    • Primary Purpose: Supportive Care
    • Masking: Double (Participant, Care Provider)
  • Study Primary Completion Date: August 31, 2020

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.

Interventions

  • Dietary Supplement: Teramune Botanical Extract
    • Combination blend of aromatic plant extracts in an emulsifier carrier.
  • Other: Placebo
    • Emulsifier carrier without active supplement ingredients.

Arms, Groups and Cohorts

  • Experimental: Aromatic Extract
    • Participants receive the aromatic botanical extract orally every 4-6 waking hours for 3 days.
  • Placebo Comparator: Placebo
    • Participants receive the placebo matching the botanical extract orally every 4-6 waking hours for 3 days.

Clinical Trial Outcome Measures

Primary Measures

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

Participating in This Clinical Trial

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

Gender Eligibility: Female

self identify as female

Minimum Age: 18 Years

Maximum Age: 60 Years

Are Healthy Volunteers Accepted: Accepts Healthy Volunteers

Investigator Details

  • Lead Sponsor
    • Franklin School of Integrative Health Sciences
  • Provider of Information About this Clinical Study
    • Sponsor
  • Overall Official(s)
    • Jessie H Hawkins, PhD, Principal Investigator, Franklin School of Integrative Health Sciences
  • Overall Contact(s)
    • PI, 6152613116, info@fsihs.org

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