A Self-Controlled Study on the Treatment of Restless Legs Syndrome in Uremia With Dipyridamole
试验速览
- 阶段
- 2 期
- 状态
- 招募中
- 发起方
- 入组人数
- 80
- 试验地点
- 1
- 主要终点
- International Restless Legs Syndrome Study Group rating scale
研究概览
简要总结
The purpose of this clinical trial is to determine whether dipyridamole can treat restless legs syndrome in patients with uremia. In addition, the safety of dipyridamole will also be evaluated. The main questions this study aims to answer include: Can dipyridamole improve the symptoms of restless legs syndrome in participants? Can dipyridamole improve participants' anxiety, depression, sleep quality, and quality of life? What adverse reactions might participants experience while taking dipyridamole? This study is a self-controlled trial in which all participants receive active drug treatment. Participants will take dipyridamole daily (50 mg per dose, three times a day) for 12 weeks. The efficacy of dipyridamole will be evaluated by comparing relevant scale scores and laboratory indicators before and after treatment. In addition, adverse reactions during the treatment follow-up will be monitored to assess the safety of dipyridamole in this patient population.
详细描述
This study is a self-controlled study in which all participants received active drug treatment for 6 months. The efficacy and safety of dipyridamole were evaluated by comparing changes in relevant scale scores before and after treatment. The study screened patients receiving maintenance hemodialysis at the Hemodialysis Center of the First Affiliated Hospital of Chongqing Medical University, with a baseline score of greater than 15 on the International Restless Legs Syndrome Rating Scale (IRLS). Approximately 80 patients met the inclusion criteria of the study and were willing to sign informed consent. General clinical data and pre-study laboratory parameters were collected, including age, sex, body mass index, serum iron, ferritin, serum parathyroid hormone, hemoglobin, albumin, dialysis adequacy, IRLS, Pittsburgh Sleep Quality Index, Hamilton Depression Rating Scale, Hamilton Anxiety Rating Scale, and KDQOLTM-36. All enrolled patients were instructed to take dipyridamole tablets orally at a dose of 50 mg three times daily for 12 weeks. During the study, the occurrence of drug-related adverse reactions such as nausea, headache, dizziness, diarrhea, insomnia, fatigue, and bleeding was also recorded. At the end of the treatment period, general clinical data, laboratory parameters, and relevant scale assessment results were collected again.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 75 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •(1) Maintenance hemodialysis for ≥3 months;(2) Age between 18-75 years;(3) Diagnosed with Restless Legs Syndrome (RLS) according to IRLSSG standards with a score >15;(4) Willing to cooperate with this study.
排除标准
- •(1). Patients with other cerebrovascular, muscular, and movement system diseases affecting the assessment of RLS;(2). Patients with active bleeding, such as gastrointestinal bleeding or intracerebral hemorrhage;(3). Patients who have been on dipyridamole for a long time;(4). Patients who have taken other medications that may affect RLS in the last 3 weeks, such as dopamine agonists/antagonists, tricyclic antidepressants, lithium, etc.;(5). Patients with a history of psychosis;(6). Pregnant or breastfeeding women;(7). Patients who are allergic or intolerant to dipyridamole;(8). Patients who cannot or are unwilling to cooperate with this study.
研究组 & 干预措施
Participants will: Take dipyridamole daily (50mg each time, three times a day) for 12 weeks
Participants will: Take dipyridamole daily (50mg each time, three times a day) for 12 weeks
干预措施: Dipyridamole 50mg tid (Drug)
结局指标
主要结局
International Restless Legs Syndrome Study Group rating scale
时间窗: From enrollment to the end of treatment at 12 weeks
The treatment effect on participants' restless legs syndrome is mainly assessed through their scores on the International Restless Legs Syndrome Study Group rating scale before and after treatment.
International Restless Legs Syndrome Study Group rating scale
时间窗: From enrollment to the end of treatment at 6 months
The treatment effect on participants' restless legs syndrome is mainly assessed through their scores on the International Restless Legs Syndrome Study Group rating scale before and after treatment.
次要结局
- Hamilton Depression Rating Scale(From enrollment to the end of treatment at 12 weeks)
- Hamilton Anxiety Scale(From enrollment to the end of treatment at 12 weeks)
- Pittsburgh Sleep Quality Index(From enrollment to the end of treatment at 12 weeks)
- KDQOL-36 Scale(From enrollment to the end of treatment at 12 weeks)
- Hamilton Depression Rating Scale(From enrollment to the end of treatment at 6 months)
- Hamilton Anxiety Scale(From enrollment to the end of treatment at 6 months)
- Pittsburgh Sleep Quality Index(From enrollment to the end of treatment at 6 months)
- KDQOL-36 Scale(From enrollment to the end of treatment at 6 months)
研究者
Yunfeng Xia
Chief Physician of Nephrology、Clinical Professor
First Affiliated Hospital of Chongqing Medical University