TGIR Randomized Placebo-controlled Healthy Subject Study

University of British Columbia

Status and phase: Enrolling; Phase 4

Conditions: Healthy

Treatments: Drug: TGIR (Traditional Gastrointestinal Remedy); Drug: Placebo

Study type: Interventional

Funder types: Other

Identifiers

NCT05783193

H21-03899

Details and patient eligibility

About

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.

Full 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).

Enrollment: 24 estimated patients

Sex: All

Ages: 18 to 65 years old

Volunteers: Accepts Healthy Volunteers

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

Trial design

Primary purpose: Other

Allocation: Randomized

Interventional model: Crossover Assignment

Masking: Single Blind

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24 participants in 2 patient groups, including a placebo group

TGIR (Traditional Gastrointestinal Remedy)

Experimental group

Description:

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

Treatment:

Drug: TGIR (Traditional Gastrointestinal Remedy)

Control (Microcrystalline cellulose)

Placebo Comparator group

Description:

Placebo control (2 capsules)

Treatment:

Drug: Placebo