TGIR (Traditional Gastrointestinal Remedy) Randomized Placebo-controlled Healthy Subject Study
试验速览
- 阶段
- 4 期
- 状态
- 招募中
- 入组人数
- 24
- 试验地点
- 1
- 主要终点
- Standardized heat sensitivity testing - Brief Thermal Sensitization (BTS)
研究概览
简要总结
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.
详细描述
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).
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Crossover
- 主要目的
- Other
- 盲法
- Single (Participant)
入排标准
- 年龄范围
- 18 Years 至 65 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •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
排除标准
- •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
研究组 & 干预措施
TGIR (Traditional Gastrointestinal Remedy)
TGIR (500mg/capsule), 1.0g (2 capsules)
干预措施: TGIR (Traditional Gastrointestinal Remedy) (Drug)
Control (Microcrystalline cellulose)
Placebo control (2 capsules)
干预措施: Placebo (Drug)
结局指标
主要结局
Standardized heat sensitivity testing - Brief Thermal Sensitization (BTS)
时间窗: 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)
时间窗: 60min post-treatment
PVT performance on a computer-based test measures lapses, defined as reaction times exceeding 500 msec or failure to react.
次要结局
- Physiological monitoring - Heart rate(Recording every 30min over 4 hours post-treatment)
- Physiological monitoring - Blood pressure(Recording every 30min over 4 hours post-treatment)
研究者
Pouya Azar
Medical Manager
University of British Columbia