A Self-Controlled Study on the Treatment of Restless Legs Syndrome in Uremia With Dipyridamole

Обзор

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.

Подробное описание

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.

Вмешательства

• Препарат Dipyridamole 50mg tid
  Participants will take dipyridamole daily (50mg each time, three times a day) for 12 weeks

Первичные конечные точки

• International Restless Legs Syndrome Study Group rating scale [Срок оценки: From enrollment to the end of treatment at 12 weeks]

Вторичные конечные точки (4)

• Hamilton Depression Rating Scale [Срок оценки: From enrollment to the end of treatment at 12 weeks]
• Hamilton Anxiety Scale [Срок оценки: From enrollment to the end of treatment at 12 weeks]
• Pittsburgh Sleep Quality Index [Срок оценки: From enrollment to the end of treatment at 12 weeks]
• KDQOL-36 Scale [Срок оценки: From enrollment to the end of treatment at 12 weeks]

Критерии участия

Критерии включения

(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.

Критерии исключения

(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.

Критерии приведены из реестра в оригинале (на английском). Окончательную оценку соответствия проводит исследовательский центр.

Здоровые добровольцы: Нет

Дизайн исследования

Распределение

Не применимо

Модель

Одна группа

Маскирование

Открытое

Основная цель

Лечение

Центры проведения

Китай · 1 центр

• First Affiliated Hospital of Chongqing Medical University — Чунцин

Идентификаторы

NCT: NCT07199504 · 2025-451-02 · CYYY-SSCX202522

Первоисточники (государственные реестры)

• ClinicalTrials.gov (NIH, США)

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