TGIR Randomized Placebo-controlled Healthy Subject Study

Study Overview
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Brief Summary
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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
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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).

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

Conditions
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Healthy

Intervention / Treatment
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* Drug: TGIR (Traditional Gastrointestinal Remedy)
* Drug: Placebo


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 65 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Other
Allocation: Randomized
Intervention Model: Crossover Assignment
Interventional Model Description: Randomized, placebo-controlled, crossover trial with healthy volunteers to delineate additional information on a Health Canada-approved natural health product.
Masking: Single


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: TGIR (Traditional Gastrointestinal Remedy)<br>TGIR (500mg/capsule), 1.0g (2 capsules) | Drug: TGIR (Traditional Gastrointestinal Remedy)<br>* TGIR botanical formulation<br>|
| Placebo Comparator: Control (Microcrystalline cellulose)<br>Placebo control (2 capsules) | Drug: Placebo<br>* Placebo capsules<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Standardized heat sensitivity testing - Brief Thermal Sensitization (BTS) | 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). | 30-60min post-treatment | 
| Measure of reaction time - Psychomotor vigilance task (PVT) | PVT performance on a computer-based test measures lapses, defined as reaction times exceeding 500 msec or failure to react. | 60min post-treatment | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Physiological monitoring - Heart rate | Heart rate monitoring | Recording every 30min over 4 hours post-treatment | 
| Physiological monitoring - Blood pressure | Blood pressure monitoring | Recording every 30min over 4 hours post-treatment |