Healthy
Conditions
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).
Interventions
DRUGTGIR (Traditional Gastrointestinal Remedy)
TGIR botanical formulation
DRUGPlacebo
Placebo capsules
Sponsors
Resilience Biosciences Inc (RBI)
University of British Columbia
Study design
Allocation
RANDOMIZED
Intervention model
CROSSOVER
Primary purpose
OTHER
Masking
SINGLE (Subject)
Intervention model description
Randomized, placebo-controlled, crossover trial with healthy volunteers to delineate additional information on a Health Canada-approved natural health product.
Eligibility
Sex/Gender
ALL
Age
18 Years to 65 Years
Healthy volunteers
Yes
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| 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
| Measure | Time frame | Description |
|---|---|---|
| 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 |
Countries
Canada
Contacts
Primary ContactFiona Choi, PhD
Outcome results
None listed