Clinical trial NCT05783193: TGIR Randomized Placebo-controlled Healthy Subject Study
Official title: TGIR (Traditional Gastrointestinal Remedy) Randomized Placebo-controlled Healthy Subject Study
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: PHASE4
Conditions: Healthy
Lead sponsor: University of British Columbia
Sponsor class: OTHER
Collaborators: name: Resilience Biosciences Inc (RBI)
First posted: 2023-03-24
Enrollment: 24
Sex: ALL
Minimum age (years): 18
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: CROSSOVER
Intervention model description: Randomized, placebo-controlled, crossover trial with healthy volunteers to delineate additional information on a Health Canada-approved natural health product.
Primary purpose: OTHER

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).

Eligibility 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

Primary outcomes:
measure: Standardized heat sensitivity testing - Brief Thermal Sensitization (BTS)
timeFrame: 30-60min post-treatment
measure: Measure of reaction time - Psychomotor vigilance task (PVT)
timeFrame: 60min post-treatment
Secondary outcomes:
measure: Physiological monitoring - Heart rate
timeFrame: Recording every 30min over 4 hours post-treatment
measure: Physiological monitoring - Blood pressure
timeFrame: Recording every 30min over 4 hours post-treatment
Other outcomes:
Locations:
city: Vancouver
country: Canada
facility: Joseph & Rosalie Segal & Family Health Centre
state: British Columbia
Study officials:
affiliation: University of British Columbia
name: Pouya Rezazadeh-Azar, MD
role: PRINCIPAL_INVESTIGATOR
References: