Efficacy and safety of electroacupuncture plus Suanzaoren decoction for insomnia following stroke: a randomized controlled trial
- Conditions
- insomnia following stroke
- Registration Number
- ITMCTR2000003167
- Lead Sponsor
- Yichang Hospital of Traditional Chinese Medicine, Clinical Medical College of Traditional Chinese Medicine, China Three Gorges University
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Pending
- Sex
- All
- Target Recruitment
- Not specified
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.
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.
Study & Design
- Study Type
- Interventional study
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method
- Secondary Outcome Measures
Name Time Method