TGIR Randomized Placebo-controlled Healthy Subject Study

NCT05783193 | Unknown Phase 4 DMC

• 1 other identifier: H21-03899
• Study Type: interventional
• Target: 24
• Locations: 1 country
• Sites: 1

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.

Conditions

Healthy

Outcome Measures

Primary Outcomes (2)

• 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

Secondary Outcomes (2)

• Physiological monitoring - Heart rate

  Recording every 30min over 4 hours post-treatment

• Physiological monitoring - Blood pressure

  Recording every 30min over 4 hours post-treatment

Study Arms (2)

TGIR (Traditional Gastrointestinal Remedy)

EXPERIMENTAL

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

Drug: TGIR (Traditional Gastrointestinal Remedy)

Control (Microcrystalline cellulose)

PLACEBO COMPARATOR

Placebo control (2 capsules)

Drug: Placebo

Interventions

TGIR (Traditional Gastrointestinal Remedy) DRUG

TGIR botanical formulation

TGIR (Traditional Gastrointestinal Remedy)

Placebo DRUG

Placebo capsules

Control (Microcrystalline cellulose)

Eligibility Criteria

• Age: 18 Years - 65 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• University of British Columbia: lead
• Resilience Biosciences Inc (RBI): collaborator

Study Sites (1)

Joseph & Rosalie Segal & Family Health Centre

Vancouver, British Columbia, V5Z 1N1, Canada

RECRUITING

Study Officials

• Pouya Rezazadeh-Azar, MD

  University of British Columbia

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Fiona Choi, PhD

CONTACT

604-827-4364; fionac@mail.ubc.ca

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: PARTICIPANT
• Purpose: OTHER
• Intervention Model: CROSSOVER
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Medical Manager

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

Study Record Dates

• First Submitted: March 13, 2023
• First Posted: March 24, 2023
• Study Start: November 1, 2022
• Primary Completion: December 1, 2023
• Study Completion: December 1, 2023
• Last Updated: March 24, 2023

Record last verified: 2022-09

Data Sharing

• IPD Sharing: Will not share

Locations

CA (1)