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| Name | Class |
|---|---|
| Resilience Biosciences Inc (RBI) | UNKNOWN |
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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.
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).
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| TGIR (Traditional Gastrointestinal Remedy) | Experimental | TGIR (500mg/capsule), 1.0g (2 capsules) |
|
| Control (Microcrystalline cellulose) | Placebo Comparator | Placebo control (2 capsules) |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| TGIR (Traditional Gastrointestinal Remedy) | Drug | TGIR botanical formulation |
|
| 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 |
| 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 |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Fiona Choi, PhD | Contact | 604-827-4364 | fionac@mail.ubc.ca |
| Name | Affiliation | Role |
|---|---|---|
| Pouya Rezazadeh-Azar, MD | University of British Columbia | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Joseph & Rosalie Segal & Family Health Centre | Recruiting | Vancouver | British Columbia | V5Z 1N1 | Canada |
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Randomized, placebo-controlled, crossover trial with healthy volunteers to delineate additional information on a Health Canada-approved natural health product.
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| Placebo | Drug | Placebo capsules |
|
| Recording every 30min over 4 hours post-treatment |