TGIR Randomized Placebo-controlled Healthy Subject Study

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

UNKNOWN

Clinical Phase

PHASE4

Total Enrollment

24 participants

Study Classification

INTERVENTIONAL

Study Start Date

2022-11-01

Study Completion Date

2023-12-31

Brief Summary

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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.

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Detailed Description

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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).

Conditions

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Healthy

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

CROSSOVER

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

Primary Study Purpose

OTHER

Blinding Strategy

SINGLE

Participants

Study Groups

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TGIR (Traditional Gastrointestinal Remedy)

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

Group Type EXPERIMENTAL

TGIR (Traditional Gastrointestinal Remedy)

Intervention Type DRUG

TGIR botanical formulation

Control (Microcrystalline cellulose)

Placebo control (2 capsules)

Group Type PLACEBO_COMPARATOR

Placebo

Intervention Type DRUG

Placebo capsules

Interventions

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TGIR (Traditional Gastrointestinal Remedy)

TGIR botanical formulation

Intervention Type DRUG

Placebo

Placebo capsules

Intervention Type DRUG

Eligibility Criteria

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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

Minimum Eligible Age

18 Years

Maximum Eligible Age

65 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes