ITMCTR2000003167
Not yet recruiting
Phase 1
Efficacy and safety of electroacupuncture plus Suanzaoren decoction for insomnia following stroke: a randomized controlled trial
Yichang Hospital of Traditional Chinese Medicine, Clinical Medical College of Traditional Chinese Medicine, China Three Gorges University0 sitesTBD
Conditionsinsomnia following stroke
Overview
- Phase
- Phase 1
- Intervention
- Not specified
- Conditions
- insomnia following stroke
- Sponsor
- Yichang Hospital of Traditional Chinese Medicine, Clinical Medical College of Traditional Chinese Medicine, China Three Gorges University
- Status
- Not yet recruiting
- Last Updated
- 3 years ago
Overview
Brief Summary
No summary available.
Investigators
Eligibility Criteria
Inclusion Criteria
- •1\. Aged 18–70 years, either sex;
- •2\. Unilateral hemispheric stroke;
- •3\. Fulfilling the diagnostic criteria of insomnia according to Diagnostic and Statistical Manual of Mental Disorders, Fifth Edition;
- •4\. Right handedness.
Exclusion Criteria
- •1\. Insomnia before stroke or caused by poor sleeping conditions;
- •2\. Diagnoses of other sleep disorders such as narcolepsy, obstructive sleep apnoea syndrome or rest\-less legs syndrome;
- •3\. Neurological or psychiatric diseases;
- •4\. Patients associated with severe diabetes, hypertension, severe liver, kidney or thyroid dysfunction, and severe cardiac insufficiency;
- •5\. Inability to read, understand and complete the forms or use the rating scales;
- •6\. The presence of implants that could interfere with EA or a history of hypersensitivity to EA;
- •7\. Having received Traditional Chinese Medicine in the past 1 months;
- •8\. Having participated in other trials;
- •9\. Taking sleep\-affecting diet or medication;
- •10\. Pregnant or preparing for pregnancy.
Outcomes
Primary Outcomes
Not specified
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