TGIR (Traditional Gastrointestinal Remedy) for Healthy Subjects

Joseph & Rosalie Segal & Family Health Centre, Vancouver, Canada
Healthy SubjectsTGIR (Traditional Gastrointestinal Remedy) - Drug
Eligibility
18 - 65
All Sexes
What conditions do you have?
Select

Study Summary

This trial tests a natural remedy to see if it has any side-effects or pain-relieving properties in healthy people.

Treatment Effectiveness

Phase-Based Effectiveness

3 of 3
Phase 4
This is further along than 93% of similar trials

Study Objectives

2 Primary · 2 Secondary · Reporting Duration: 30-60min post-treatment

30-60min post-treatment
Standardized heat sensitivity testing - Brief Thermal Sensitization (BTS)
60min post-treatment
Measure of reaction time - Psychomotor vigilance task (PVT)
Hour 4
Physiological monitoring - Blood pressure
Physiological monitoring - Heart rate

Trial Safety

Phase-Based Safety

3 of 3
This is further along than 85% of similar trials

Awards & Highlights

Drug Has Already Been Approved
The FDA has already approved this drug, and is just seeking more data.
Pivotal Trial
The final step before approval, pivotal trials feature drugs that have already shown basic safety & efficacy.

Trial Design

2 Treatment Groups

TGIR (Traditional Gastrointestinal Remedy)
1 of 2
Control (Microcrystalline cellulose)
1 of 2

Experimental Treatment

Non-Treatment Group

24 Total Participants · 2 Treatment Groups

Primary Treatment: TGIR (Traditional Gastrointestinal Remedy) · Has Placebo Group · Phase 4

TGIR (Traditional Gastrointestinal Remedy)
Drug
Experimental Group · 1 Intervention: TGIR (Traditional Gastrointestinal Remedy) · Intervention Types: Drug
Control (Microcrystalline cellulose)
Drug
PlaceboComparator Group · 1 Intervention: Placebo · Intervention Types: Drug

Trial Logistics

Trial Timeline

Screening: ~3 weeks
Treatment: Varies
Reporting: 30-60min post-treatment

Who is running the clinical trial?

University of British ColumbiaLead Sponsor
1,351 Previous Clinical Trials
1,564,565 Total Patients Enrolled
Resilience Biosciences Inc (RBI)UNKNOWN
Pouya Rezazadeh-Azar, MDPrincipal InvestigatorUniversity of British Columbia

Eligibility Criteria

Age 18 - 65 · All Participants · 2 Total Inclusion Criteria

Mark “Yes” if the following statements are true for you:
You report being in good health.
You do not have a diagnosis of chronic pain.

Who else is applying?

What state do they live in?
Washington100.0%
What site did they apply to?
Joseph & Rosalie Segal & Family Health Centre100.0%
What portion of applicants met pre-screening criteria?
Met criteria100.0%
How many prior treatments have patients received?
0100.0%

Frequently Asked Questions

Are there still spots available for participants in this experiment?

"Affirmative. Accessing the data on clinicaltrials.gov reveals that this medical trial is presently open for recruitment and was originally posted on November 1st 2022. The study has a current target of 24 patients from one site, with the most recent update occuring March 13th 2023." - Anonymous Online Contributor

Unverified Answer

Is it feasible to join this medical study?

"To qualify for this clinical trial, potential participants must lie within the age bracket of 18 and 65 years old with no existing medical conditions. 24 individuals in total will be accepted into the study." - Anonymous Online Contributor

Unverified Answer

Has TGIR been certified by the FDA?

"Based on the Phase 4 status of TGIR, our team concluded that this traditional gastrointestinal remedy was safe and assigned it a score of 3." - Anonymous Online Contributor

Unverified Answer

Is this research program open to octogenarians?

"Individuals aged 18-65 are suitable for this clinical trial, however there are separate trials available to those under the age of eighteen as well as those over 65. Specifically, 54 and 372 such studies respectively." - Anonymous Online Contributor

Unverified Answer

How many research participants are currently engaged in this investigation?

"Affirmative. According to the data hosted on clinicaltrials.gov, this medical trial is actively seeking participants - which was first published on November 1st 2022 and last edited March 13th 2023. 24 volunteers need to be recruited from a single centre for the study." - Anonymous Online Contributor

Unverified Answer
Please Note: These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.