Ketum and Pain Tolerence
试验速览
- 阶段
- 不适用
- 入组人数
- 20
- 试验地点
- 1
- 主要终点
- Pain tolerance
研究概览
简要总结
The study aim is to evaluate potential analgesic properties of ketum using the cold pressor task.
详细描述
Participants in the proposed study will be individuals who report consuming ketum more than once a day, daily for the past 12 months. The study is a placebo-controlled, double-blind within-subject repeated mesaures design. Participants will ingest a sequence of ketum and placebo drinks prepared by pharmacologists at USM Centre for Drug Research and their pain tolerance will be measured by the cold pressor task after ingesting ketum or placebo.
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
- Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
盲法说明
Ketum and placebo drinks will be matched for taste and appearence. Each study participant will receive a sequence of ketum and placebo drinks in random order.
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
- •Individuals who report drinking ketum decoction more than once a day, daily for the past 12 months.
排除标准
- •(1) tested positive for illicit drug use including morphine, cannabis, methamphetamine, amphetamine, methadone, benzodiazepine and ketamine; (2) have current or previous history of psychological or neurological problems (self-report); (3) have current or previous alcohol use history (self-report); (4) HIV infections; (5) history of chronic liver disease (e.g. cirrhosis, hepatitis A, B, C, etc.) 6) non-alcoholic fatty liver disease; (7) history of coronary heart disease and diabetes; (8) existing chronic pain condition and (9) history of psychiatric disorders. Exclusion criteria for female particiapns: (1) pregnancy, (2) nursing.
研究组 & 干预措施
Placebo
Each participant will consume a sequence of active ketum or placebo drinks. Pain tolerance will be measured using the cold pressor task after consuming each drink.
干预措施: Placebo (Drug)
Ketum
Each participant will consume a sequence of active ketum or placebo drinks. Pain tolerance will be measured using the cold pressor task after consuming each drink.
干预措施: Ketum (Drug)
结局指标
主要结局
Pain tolerance
时间窗: 3 hours
The duration (seconds) participants can keep their hands immersed in the water bath
次要结局
未报告次要终点
研究者
Vicknasingam B Kasinather
Professor
Universiti Sains Malaysia