NCT05783193

TGIR Randomized Placebo-controlled Healthy Subject Study

TGIR (Traditional Gastrointestinal Remedy) Randomized Placebo-controlled Healthy Subject Study

• Status: Unknown
• Phase: Phase 4
• Study type: Interventional
• Enrollment: 24 (estimated)
• Sponsor: University of British Columbia · Academic / Other
• Sex: All
• Age: 18 Years – 65 Years
• Healthy volunteers: Accepted

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.

Detailed 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).

Conditions

• Healthy

Interventions

Type	Name	Description
DRUG	TGIR (Traditional Gastrointestinal Remedy)	TGIR botanical formulation
DRUG	Placebo	Placebo capsules

Timeline

• Start date: 2022-11-01
• Primary completion: 2023-12-01
• Completion: 2023-12-01
• First posted: 2023-03-24
• Last updated: 2023-03-24

Locations

1 site across 1 country: Canada