TGIR Randomized Placebo-controlled Healthy Subject Study

Sponsor

University of British Columbia (Other)

Overall Status

Recruiting

CT.gov ID

NCT05783193

Collaborator

Resilience Biosciences Inc (RBI) (Other)

Enrollment

Location

Arms

Anticipated Duration (Months)

1.8

Patients Per Site Per Month

Study Details

Study Description

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.

Condition or Disease	Intervention/Treatment	Phase
Healthy	Drug: TGIR (Traditional Gastrointestinal Remedy) Drug: Placebo	Phase 4

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 Design

Study Type:

Interventional

Anticipated Enrollment :

24 participants

Allocation:

Randomized

Intervention Model:

Crossover Assignment

Intervention Model Description:

Randomized, placebo-controlled, crossover trial with healthy volunteers to delineate additional information on a Health Canada-approved natural health product.Randomized, placebo-controlled, crossover trial with healthy volunteers to delineate additional information on a Health Canada-approved natural health product.

Masking:

Single (Participant)

Primary Purpose:

Other

Official Title:

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

Actual Study Start Date :

Nov 1, 2022

Anticipated Primary Completion Date :

Dec 1, 2023

Anticipated Study Completion Date :

Dec 1, 2023

Arms and Interventions

Arm	Intervention/Treatment
Experimental: TGIR (Traditional Gastrointestinal Remedy) TGIR (500mg/capsule), 1.0g (2 capsules)	Drug: TGIR (Traditional Gastrointestinal Remedy) TGIR botanical formulation
Placebo Comparator: Control (Microcrystalline cellulose) Placebo control (2 capsules)	Drug: Placebo Placebo capsules

Arm

Intervention/Treatment

Experimental: TGIR (Traditional Gastrointestinal Remedy)

TGIR (500mg/capsule), 1.0g (2 capsules)

Drug: TGIR (Traditional Gastrointestinal Remedy)

TGIR botanical formulation

Placebo Comparator: Control (Microcrystalline cellulose)

Placebo control (2 capsules)

Drug: Placebo

Placebo capsules

Outcome Measures

Primary Outcome Measures

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

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

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years to 65 Years

Sexes Eligible for Study:

All

Accepts 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

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Joseph & Rosalie Segal & Family Health Centre	Vancouver	British Columbia	Canada	V5Z 1N1

Sponsors and Collaborators

University of British Columbia
Resilience Biosciences Inc (RBI)

Investigators

Principal Investigator: Pouya Rezazadeh-Azar, MD, University of British Columbia

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

Responsible Party:

Pouya Azar, Medical Manager, University of British Columbia

ClinicalTrials.gov Identifier:

NCT05783193

Other Study ID Numbers:

H21-03899

First Posted:

Mar 24, 2023

Last Update Posted:

Mar 24, 2023

Last Verified:

Sep 1, 2022

Individual Participant Data (IPD) Sharing Statement:

Plan to Share IPD:

Studies a U.S. FDA-regulated Drug Product:

Studies a U.S. FDA-regulated Device Product:

Study Results

No Results Posted as of Mar 24, 2023