Health TrialsbyHealthPanel

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

ConditionRestless Leg Syndrome Due to Uraemia
Trial statusRecruiting
Trial phasePhase 2, Phase 3
Trial typeInterventional
Biological sexAll
Age18-75
SponsorYunfeng Xia

About this trial

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.

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

None

Disqualifiers

None

Trial design

Design model

Single group

Treatments tested in this trial

  • Dipyridamole 50mg tid

    Drug

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

Treatment groups

80 Participants
are divided into 1 treatment group
Group A: Participants will: Take dipyridamole daily (50mg each time, three times a day) for 12 weeksExperimental treatment 1 intervention

Trial outcomes

Primary outcomes

1

International Restless Legs Syndrome Study Group rating scale

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.

Time frame
From enrollment to the end of treatment at 12 weeks

Secondary outcomes

1

Hamilton Depression Rating Scale

The changes in participants' depressive symptoms were assessed using the Hamilton Depression Rating Scale before and after they received treatment.

Time frame
From enrollment to the end of treatment at 12 weeks
2

Hamilton Anxiety Scale

The changes in participants' anxiety levels were assessed using the Hamilton Anxiety Scale before and after they received treatment.

Time frame
From enrollment to the end of treatment at 12 weeks
3

Pittsburgh Sleep Quality Index

The changes in participants' sleep quality were assessed using the Pittsburgh Sleep Quality Index before and after they received treatment.

Time frame
From enrollment to the end of treatment at 12 weeks
4

KDQOL-36 Scale

Changes in participants' quality of life were assessed using the KDQOL-36 Scale before and after they received treatment.

Time frame
From enrollment to the end of treatment at 12 weeks

Other outcomes

Sponsors and contacts

Click on the lead sponsor to view all of their trials.

Yunfeng Xia

Lead sponsor

First Affiliated Hospital of Chongqing Medical University

Sponsor institution

Source ClinicalTrials.gov
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