HealthyPhase 4NCT05783193
TGIR Randomized Placebo-controlled Healthy Subject Study
A Phase 4 study testing TGIR (Traditional Gastrointestinal Remedy) in people with Healthy, run by University of British Columbia at 1 site in Canada.
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. Read more about this study
- Who is it for?
- Ages 18 to 65 yearsHealthy volunteers can take part
- Conditions the study is for
- Healthy
- What is being tested?
- TGIR (Traditional Gastrointestinal Remedy)
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 24 participants
- Where
- 1 siteCanada
- Study dates
- 1 Nov 2022to Dec 2023
- Phase
- Phase 4
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 65 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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 locations and contacts
1 site in 1 country.
Canada1 site, 1 recruiting
- Recruiting
Joseph & Rosalie Segal & Family Health Centre
Vancouver, British Columbia, V5Z 1N1
Fiona Choi, PhD, 604-827-4364, fionac@mail.ubc.ca
About this study
Official title: TGIR (Traditional Gastrointestinal Remedy) Randomized Placebo-controlled Healthy Subject Study
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.
Read the detailed 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).
- Conditions
- Healthy
- Being tested
- TGIR (Traditional Gastrointestinal Remedy), Placebo
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
TGIR (Traditional Gastrointestinal Remedy)Drug
TGIR botanical formulation
PlaceboDrug
Placebo capsules
| Study group | Role | What they receive |
|---|---|---|
| TGIR (Traditional Gastrointestinal Remedy) | Experimental | TGIR (500mg/capsule), 1.0g (2 capsules) Receives: Drug: TGIR (Traditional Gastrointestinal Remedy) |
| Control (Microcrystalline cellulose) | Placebo comparator | Placebo control (2 capsules) Receives: Drug: Placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
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).
Measured: 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.
Measured: 60min post-treatment
Secondary outcomes (2)
Physiological monitoring - Heart rate
Heart rate monitoring
Measured: Recording every 30min over 4 hours post-treatment
Physiological monitoring - Blood pressure
Blood pressure monitoring
Measured: Recording every 30min over 4 hours post-treatment
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted24 Mar 2023
- Study start1 Nov 2022
- Primary completionDec 2023 (estimated)
- Study completionDec 2023 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for HealthyStudies of the same condition, open and under way.
- More trials run by University of British ColumbiaThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 4
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Crossover
- Model description
- Randomized, placebo-controlled, crossover trial with healthy volunteers to delineate additional information on a Health Canada-approved natural health product.
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 24 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University of British Columbia
- Sponsor type
- University, hospital or other
- Collaborators
- Resilience Biosciences Inc (RBI)
- Responsible party
- Principal investigator, Pouya Azar, University of British Columbia
- Investigators
- Pouya Rezazadeh-Azar, MD, Principal investigator, University of British Columbia
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05783193
- Sponsor's protocol ID
- H21-03899
- Status last verified
- Sep 2022
- First submitted
- 13 Mar 2023
- Last updated
- 24 Mar 2023
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 24 Mar 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- TGIR (Traditional Gastrointestinal Remedy) Randomized Placebo-controlled Healthy Subject Study
- ClinicalTrials.gov ID
- NCT05783193
- Acronym / sponsor ID
- H21-03899
- Conditions
- Healthy
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 24 participants (estimated)
- Lead sponsor
- University of British ColumbiaUniversity, hospital or other
- Collaborators
- Resilience Biosciences Inc (RBI)
- Study start
- 1 Nov 2022 (actual)
- Primary completion
- Dec 2023 (estimated)
- Study completion
- Dec 2023 (estimated)
- First posted
- 24 Mar 2023 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Detailed 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).
Study design
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Single blind (participant)
- Number of arms
- 2
- Model description
- Randomized, placebo-controlled, crossover trial with healthy volunteers to delineate additional information on a Health Canada-approved natural health product.
| Arm | Type | Receives |
|---|---|---|
| TGIR (Traditional Gastrointestinal Remedy) | Experimental | Drug: TGIR (Traditional Gastrointestinal Remedy)TGIR (500mg/capsule), 1.0g (2 capsules) |
| Control (Microcrystalline cellulose) | Placebo comparator | Drug: PlaceboPlacebo control (2 capsules) |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- 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
Key exclusion criteria (6 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| TGIR (Traditional Gastrointestinal Remedy)TGIR botanical formulation | Drug | TGIR (Traditional Gastrointestinal Remedy) |
| PlaceboPlacebo capsules | Drug | Control (Microcrystalline cellulose) |
Primary outcome
Standardized heat sensitivity testing - Brief Thermal Sensitization (BTS)
Time frame: 30-60min post-treatment
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).
Measure of reaction time - Psychomotor vigilance task (PVT)
Time frame: 60min post-treatment
PVT performance on a computer-based test measures lapses, defined as reaction times exceeding 500 msec or failure to react.
2 secondary outcomes
Physiological monitoring - Heart rate
Time frame: Recording every 30min over 4 hours post-treatment
Physiological monitoring - Blood pressure
Time frame: Recording every 30min over 4 hours post-treatment
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 24 Mar 2023.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Pouya Rezazadeh-Azar, MD principal investigator
University of British Columbia
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 4 study testing TGIR (Traditional Gastrointestinal Remedy) in people with Healthy, run by University of British Columbia at 1 site in Canada.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 6 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 24 Mar 2023. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Canada. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Fiona Choi, PhD (604-827-4364, fionac@mail.ubc.ca), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Standardized heat sensitivity testing - Brief Thermal Sensitization (BTS) (time frame: 30-60min post-treatment). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 24 Mar 2023.