TGIR Randomized Placebo-controlled Healthy Subject Study

• Status: Recruiting
• Trial end date: 2023-12-01
• Target enrollment: 0
• Participant gender: All

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.

• Phase: Phase 4
• Accepts Healthy Volunteers?: Accepts Healthy Volunteers

Details

• Lead Sponsor: University of British Columbia
• Collaborator: Resilience Biosciences Inc (RBI)

Criteria

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 Criteria:

• Participants who are pregnant, breastfeeding or planning to become pregnant during the course of the study

• History or current clinically significant hematological, renal, endocrine, pulmonary, gastrointestinal, cardiovascular, neurological, or psychiatric disease that may pose a significant safety risk or diminish a participant's ability to undergo all study procedures 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 as valerian, skullcap, hops, california poppy, passiflora, and cannabis during the study period