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Efficacy and safety of electroacupuncture plus Suanzaoren decoction for insomnia following stroke: a randomized controlled trial

Efficacy and safety of electroacupuncture plus Suanzaoren decoction for insomnia following stroke: a randomized controlled trial

Status
Active, not recruiting
Phases
Early Phase 1
Study type
Interventional
Source
ChiCTR
Registry ID
ChiCTR2000031413
Enrollment
Unknown
Registered
2020-03-30
Start date
2020-04-10
Completion date
Unknown
Last updated
2020-04-06

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

insomnia following stroke

Interventions

Sponsors

Yichang Hospital of Traditional Chinese Medicine, Clinical Medical College of Traditional Chinese Medicine, China Three Gorges University
Lead Sponsor

Eligibility

Sex/Gender
All
Age
18 Years to 70 Years

Inclusion 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

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.

Design outcomes

Primary

MeasureTime frame
Pittsburgh Sleep Quality Index;Polysomnography;

Secondary

MeasureTime frame
Insomnia Severing Index;Hospital Anxiety and Depression Scale;National Institutes of Health Stroke Scale;Magnetic Resonance Imaging brain scanning;functional magnetic resonance imaging;nocturnal concentration of melatonin;

Countries

China

Contacts

Public ContactYang Songbai

Yichang Hospital of Traditional Chinese Medicine, Clinical Medical College of Traditional Chinese Medicine, China Three Gorges University

1581190770@qq.com+86 13972606779

Outcome results

None listed

Source: ChiCTR (via WHO ICTRP) · Data processed: Feb 14, 2026