Dipyridamole for restless legs in people with uremia on hemodialysis

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

What this trial studies

This is a single-center, self-controlled interventional study in which all participants receive dipyridamole 50 mg three times daily for 12 weeks and outcomes are compared before and after treatment. About 80 maintenance hemodialysis patients with moderate-to-severe restless legs syndrome (IRLS score >15) were enrolled and had baseline clinical data and laboratory tests collected. Key outcomes include changes in IRLS, sleep quality (PSQI), depression and anxiety scales (HAM-D, HAM-A), KDQOL-36 quality of life scores, and laboratory markers such as serum iron, ferritin, PTH, hemoglobin, and dialysis adequacy. Adverse events including bleeding, nausea, headache, dizziness, diarrhea, insomnia, and fatigue were monitored throughout the treatment period.

Why it matters

Who can join: the full rules

Inclusion Criteria:

(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.

Exclusion Criteria:

(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.

Where it's running

• First Affiliated Hospital of Chongqing Medical University
  Chongqing, Chongqing Municipality, China Recruiting

Study contacts

• Study coordinator: yunfeng xia
• Email: yunfengxia0920@126.com
• Phone: 86-023-89012687

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How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.