TGIR Randomized Placebo-controlled Healthy Subject Study

Phase 4

Recruiting

• Conditions: Healthy
• Interventions: Drug: Placebo; Drug: TGIR (Traditional Gastrointestinal Remedy)

• Registration Number: NCT05783193
• Lead Sponsor: University of British Columbia

Brief 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).

Study Timeline

• Status Verified: 2022-09
• Study Start: 2022-11-01
• Study First Submitted: 2023-03-13
• Study First Submitted QC: 2023-03-13
• Last Update Submitted: 2023-03-13
• Study First Posted: 2023-03-24
• Last Update Posted: 2023-03-24
• Primary Completion: 2023-12
• Study Completion: 2023-12

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 24

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: CROSSOVER

Arm && Interventions

Group	Intervention	Description
Control (Microcrystalline cellulose)	Placebo	Placebo control (2 capsules)
TGIR (Traditional Gastrointestinal Remedy)	TGIR (Traditional Gastrointestinal Remedy)	TGIR (500mg/capsule), 1.0g (2 capsules)

Primary Outcome Measures

Name	Time	Method
Standardized heat sensitivity testing - Brief Thermal Sensitization (BTS)	30-60min post-treatment	Participants rate the painfulness of the heat stimulation on a paper 100 mm Visual Analogue Scale anchored with the descriptors "no pain" (0 mm) and "worst pain imaginable" (100 mm).
Measure of reaction time - Psychomotor vigilance task (PVT)	60min post-treatment	PVT performance on a computer-based test measures lapses, defined as reaction times exceeding 500 msec or failure to react.

Secondary Outcome Measures

Name	Time	Method
Physiological monitoring - Heart rate	Recording every 30min over 4 hours post-treatment	Heart rate monitoring
Physiological monitoring - Blood pressure	Recording every 30min over 4 hours post-treatment	Blood pressure monitoring

Trial Locations

Locations (1)

Joseph & Rosalie Segal & Family Health Centre; 🇨🇦 Vancouver, British Columbia, Canada