Resveratrol Trial for Relief of Pain in Pseudoachondroplasia
试验速览
- 阶段
- 2 期
- 状态
- 终止
- 入组人数
- 6
- 试验地点
- 1
- 主要终点
- Pain as Assessed by Numeric Pain Rating Scale
研究概览
简要总结
The purpose of this study is to determine if self-administered oral resveratrol can dampen joint pain for individuals with pseudoachondroplasia compared to placebo. Another goal of this study is to evaluate side effects in this population.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Crossover
- 主要目的
- Treatment
- 盲法
- Triple (Participant, Investigator, Outcomes Assessor)
入排标准
- 年龄范围
- 18 Years 至 70 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •The diagnosis of pseudoachondroplasia is based on clinical assessment either in person or by photographic review by skeletal dysplasia specialist (JTH),
- •Healthy beyond pseudoachondroplasia associated complications,
排除标准
- •Current use of resveratrol
- •Current use of blood thinners, lovastatin, ketoconazole, itraconazole, fexofenadine and triazolam.
- •Other non-pseudoachondroplasia related health conditions, e.g. cancers.
- •Pregnancy or breastfeeding. Women must use adequate contraception during the study.
- •Participation in another clinical study and/or using investigational agents.
- •Use of Non-steroid anti-inflammatory (NSAIDs) or aspirin.
- •Current use of Alfentanil, Cyclosporine, Dihydroergotamine, Dofetilide, Ergotamine, Fentanyl, Flibanserin, Oxycodone, Pimavanserin, Pimozide, Quinidine, Saquinavir, Sirolimus, Tacrolimus, Temsirolimus, Theophylline, Tizanidine, Thioridazine, Fosphenytoin, Phenytoin or Warfarin.
- •Baseline level of pain of 2 or higher on 10 point scale.
- •Platelet count below 50,000 per ul on baseline complete blood count (CBC).
研究组 & 干预措施
Resveratrol, Then Placebo
Participants first received Resveratrol 125 mg/day or 5 ml daily for 90 days. After a washout period of 30 days, they then received Placebo 5ml daily for 90 days.
干预措施: resveratrol (Drug)
Resveratrol, Then Placebo
Participants first received Resveratrol 125 mg/day or 5 ml daily for 90 days. After a washout period of 30 days, they then received Placebo 5ml daily for 90 days.
干预措施: Placebo (Drug)
Placebo, Then Resveratrol
Participants first received Placebo 5ml daily for 90 days. After a washout period of 30 days, they then received Resveratrol 125 mg/day or 5 ml daily for 90 days.
干预措施: resveratrol (Drug)
Placebo, Then Resveratrol
Participants first received Placebo 5ml daily for 90 days. After a washout period of 30 days, they then received Resveratrol 125 mg/day or 5 ml daily for 90 days.
干预措施: Placebo (Drug)
结局指标
主要结局
Pain as Assessed by Numeric Pain Rating Scale
时间窗: baseline, 30 days, 60 days, 90 days
total score 0-10 with higher scores indicating greater pain
次要结局
- Health Related Quality of Life Score (HRQoL) Assessed by 36-item Short Form Health Survey Short Form-36 (SF-36)(baseline, 30 days, 60 days, 90 days)
研究者
Karen Posey
Assoc. Professor
The University of Texas Health Science Center, Houston