TGIR Randomized Placebo-controlled Healthy Subject Study

Last updated: March 13, 2023
Sponsor: University of British Columbia
Overall Status: Active - Recruiting

Phase

4

Condition

N/A

Treatment

N/A

Clinical Study ID

NCT05783193
H21-03899
  • Ages 18-65
  • All Genders
  • Accepts Healthy Volunteers

Study Summary

The primary research objective of this study is to confirm the absence of side-effects and explore any analgesic properties of the botanical formulation TGIR (Traditional Gastrointestinal Remedy) in healthy participants.

Eligibility Criteria

Inclusion

Inclusion Criteria:

  • Self-reported to be in good health
  • Between the ages of 18 and 65
  • No chronic pain diagnosis
  • Willing and able to follow study protocol and schedule

Exclusion

Exclusion Criteria:

  • Participants who are pregnant, breastfeeding or planning to become pregnant during thecourse of the study
  • History or current clinically significant hematological, renal, endocrine, pulmonary,gastrointestinal, cardiovascular, neurological, or psychiatric disease that may pose asignificant safety risk or diminish a participant's ability to undergo all studyprocedures and assessments
  • Participants who have been diagnosed with a severe medical or psychiatric condition
  • Participants who are actively taking pain medication in the past 7 days
  • COVID-19 positive and/or showing symptoms of COVID-19
  • Concurrent use of other supplements containing sedative types of herbs, such asvalerian, skullcap, hops, california poppy, passiflora, and cannabis during the studyperiod

Study Design

Total Participants: 24
Study Start date:
November 01, 2022
Estimated Completion Date:
December 31, 2023

Study Description

This study is a randomized, placebo-controlled, crossover, clinical trial with 24 healthy volunteers. Participants will be randomized to receive each of the two treatments, TGIR (500mg/capsule, total 1.0g) followed by Placebo (2 matching capsules), or vice-versa, with a week between treatments. Participants will remain in the clinic for a 4-hr observation period each day for a total of 2 clinic visits. During the course of treatment, participants will receive physiological monitoring: heart rate and blood pressure. Any adverse events and side effects will be documented throughout the study, in addition to participant feedback and perceived effects. On each day of treatment (TGIR and placebo-control), participants will receive a standardized test of analgesia using Brief Thermal Sensitization (BTS) and measures of reaction time using a computer-based Psychomotor Vigilance Task (PVT).

Connect with a study center

  • Joseph & Rosalie Segal & Family Health Centre

    Vancouver, British Columbia V5Z 1N1
    Canada

    Active - Recruiting

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