TGIR Randomized Placebo-controlled Healthy Subject Study

Healthy Clinical Trial

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT05783193
• Other study ID #: H21-03899
• Status: Recruiting
• Phase: Phase 4
• Start date: November 1, 2022
• Est. completion date: December 2023

Study information

• Verified date: September 2022
• Source: University of British Columbia
• Contact: Fiona Choi, PhD
• Phone: 604-827-4364
• Email: fionac[@]mail.ubc.ca
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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).

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 24
• Est. completion date: December 2023
• Est. primary completion date: December 2023
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years to 65 Years

Eligibility

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

Related Conditions & MeSH terms

• Healthy

Intervention

Drug:
• TGIR (Traditional Gastrointestinal Remedy)
TGIR botanical formulation
• Placebo
Placebo capsules

Locations

Country	Name	City	State
Canada	Joseph & Rosalie Segal & Family Health Centre	Vancouver	British Columbia

Sponsors (2)

Lead Sponsor	Collaborator
University of British Columbia	Resilience Biosciences Inc (RBI)

Country where clinical trial is conducted

Canada, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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
Primary	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	Physiological monitoring - Heart rate	Heart rate monitoring	Recording every 30min over 4 hours post-treatment
Secondary	Physiological monitoring - Blood pressure	Blood pressure monitoring	Recording every 30min over 4 hours post-treatment