Ignite Creation Date:
2025-12-25 @ 1:14 AM
Ignite Modification Date:
2025-12-25 @ 11:24 PM
Study NCT ID:
NCT05783193
Status:
UNKNOWN
Last Update Posted:
2023-03-24
First Post:
2023-03-13
Is NOT Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
TGIR Randomized Placebo-controlled Healthy Subject Study
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}}, 'protocolSection': {'designModule': {'phases': ['PHASE4'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'SINGLE', 'whoMasked': ['PARTICIPANT']}, 'primaryPurpose': 'OTHER', 'interventionModel': 'CROSSOVER', 'interventionModelDescription': 'Randomized, placebo-controlled, crossover trial with healthy volunteers to delineate additional information on a Health Canada-approved natural health product.'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 24}}, 'statusModule': {'overallStatus': 'UNKNOWN', 'lastKnownStatus': 'RECRUITING', 'startDateStruct': {'date': '2022-11-01', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2022-09', 'completionDateStruct': {'date': '2023-12', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2023-03-13', 'studyFirstSubmitDate': '2023-03-13', 'studyFirstSubmitQcDate': '2023-03-13', 'lastUpdatePostDateStruct': {'date': '2023-03-24', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2023-03-24', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2023-12', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Standardized heat sensitivity testing - Brief Thermal Sensitization (BTS)', 'timeFrame': '30-60min post-treatment', 'description': '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': 'Measure of reaction time - Psychomotor vigilance task (PVT)', 'timeFrame': '60min post-treatment', 'description': 'PVT performance on a computer-based test measures lapses, defined as reaction times exceeding 500 msec or failure to react.'}], 'secondaryOutcomes': [{'measure': 'Physiological monitoring - Heart rate', 'timeFrame': 'Recording every 30min over 4 hours post-treatment', 'description': 'Heart rate monitoring'}, {'measure': 'Physiological monitoring - Blood pressure', 'timeFrame': 'Recording every 30min over 4 hours post-treatment', 'description': 'Blood pressure monitoring'}]}, 'oversightModule': {'oversightHasDmc': True, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'conditions': ['Healthy']}, 'descriptionModule': {'briefSummary': '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.', 'detailedDescription': '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).'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '65 Years', 'minimumAge': '18 Years', 'healthyVolunteers': True, 'eligibilityCriteria': "Inclusion Criteria:\n\n* Self-reported to be in good health\n* Between the ages of 18 and 65\n* No chronic pain diagnosis\n* Willing and able to follow study protocol and schedule\n\nExclusion Criteria:\n\n* Participants who are pregnant, breastfeeding or planning to become pregnant during the course of the study\n* 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\n* Participants who have been diagnosed with a severe medical or psychiatric condition\n* Participants who are actively taking pain medication in the past 7 days\n* COVID-19 positive and/or showing symptoms of COVID-19\n* Concurrent use of other supplements containing sedative types of herbs, such as valerian, skullcap, hops, california poppy, passiflora, and cannabis during the study period"}, 'identificationModule': {'nctId': 'NCT05783193', 'briefTitle': 'TGIR Randomized Placebo-controlled Healthy Subject Study', 'organization': {'class': 'OTHER', 'fullName': 'University of British Columbia'}, 'officialTitle': 'TGIR (Traditional Gastrointestinal Remedy) Randomized Placebo-controlled Healthy Subject Study', 'orgStudyIdInfo': {'id': 'H21-03899'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'TGIR (Traditional Gastrointestinal Remedy)', 'description': 'TGIR (500mg/capsule), 1.0g (2 capsules)', 'interventionNames': ['Drug: TGIR (Traditional Gastrointestinal Remedy)']}, {'type': 'PLACEBO_COMPARATOR', 'label': 'Control (Microcrystalline cellulose)', 'description': 'Placebo control (2 capsules)', 'interventionNames': ['Drug: Placebo']}], 'interventions': [{'name': 'TGIR (Traditional Gastrointestinal Remedy)', 'type': 'DRUG', 'description': 'TGIR botanical formulation', 'armGroupLabels': ['TGIR (Traditional Gastrointestinal Remedy)']}, {'name': 'Placebo', 'type': 'DRUG', 'description': 'Placebo capsules', 'armGroupLabels': ['Control (Microcrystalline cellulose)']}]}, 'contactsLocationsModule': {'locations': [{'zip': 'V5Z 1N1', 'city': 'Vancouver', 'state': 'British Columbia', 'status': 'RECRUITING', 'country': 'Canada', 'contacts': [{'name': 'Fiona Choi, PhD', 'role': 'CONTACT', 'email': 'fionac@mail.ubc.ca', 'phone': '604-827-4364'}], 'facility': 'Joseph & Rosalie Segal & Family Health Centre', 'geoPoint': {'lat': 49.24966, 'lon': -123.11934}}], 'centralContacts': [{'name': 'Fiona Choi, PhD', 'role': 'CONTACT', 'email': 'fionac@mail.ubc.ca', 'phone': '604-827-4364'}], 'overallOfficials': [{'name': 'Pouya Rezazadeh-Azar, MD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'University of British Columbia'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'University of British Columbia', 'class': 'OTHER'}, 'collaborators': [{'name': 'Resilience Biosciences Inc (RBI)', 'class': 'UNKNOWN'}], 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Medical Manager', 'investigatorFullName': 'Pouya Azar', 'investigatorAffiliation': 'University of British Columbia'}}}}