ITMCTR2100005178
Not yet recruiting
Phase 1
Prospective randomized controlled clinical study of acupuncture in the treatment of restless legs syndrome after hemodialysis
Beijing Friendship Hospital Affiliated to Capital Medical University0 sitesTBD
Overview
- Phase
- Phase 1
- Intervention
- Not specified
- Conditions
- Not specified
- Sponsor
- Beijing Friendship Hospital Affiliated to Capital Medical University
- Status
- Not yet recruiting
- Last Updated
- 3 years ago
Overview
Brief Summary
No summary available.
Investigators
Eligibility Criteria
Inclusion Criteria
- •1\. Age between 18\-75 years old, male or female;
- •2\. Maintenance hemodialysis (regular dialysis, 3 times a week, at least 6 months);
- •3\. Meet the diagnostic criteria of RLS, and the severity rating scale \[IRLS] score \>\= 15;
- •4\. Body mass index 18\-40 kg/m2, hemoglobin \>\=9g/dL (\>\=4\.97 mmol/L), and ferritin concentration \>\=100 ng/m when enrolled.
- •5\. Voluntarily participate and sign the informed consent.
Exclusion Criteria
- •1\. Received acupuncture treatment in the past 2 weeks;
- •2\. Patients with clinically relevant heart and cerebrovascular diseases and blood system diseases who cannot tolerate acupuncture treatment;
- •3\. Taking drugs that may affect RLS (such as dopaminergic receptor agonists/antagonists, tricyclic antidepressants, lithium salts);
- •4\. Clinically relevant polyneuropathy or venous and arterial related diseases cause abnormal sensation in the lower extremities;
- •5\. Acute complications within 1 month, including acute infection, acute cardiovascular and cerebrovascular disease, active hepatitis, and connective tissue disease;
- •6\. Cancer radiotherapy and chemotherapy within 1 year;
- •7\. Pregnant or lactating women;
- •8\. Drug or alcohol abuse within 1 year;
- •9\. Patients with a history of severe nervous system and mental illness.
Outcomes
Primary Outcomes
Not specified
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