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A randomized controlled trial for Tong-Du Yi-Nao An-Shen granule combined with acupuncture in the treatment of post-stroke insomnia with Qi-stagnation and blood stasis syndrome

A randomized controlled trial for Tong-Du Yi-Nao An-Shen granule combined with acupuncture in the treatment of post-stroke insomnia with Qi-stagnation and blood stasis syndrome

Status
Recruiting
Phases
Unknown
Study type
Interventional
Source
ChiCTR
Registry ID
ChiCTR1800020074
Enrollment
Unknown
Registered
2018-12-13
Start date
2018-12-24
Completion date
Unknown
Last updated
2018-12-18

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

Conditions

Post-stroke insomnia

Interventions

TCM group:Oral administration of 'Tong-Du Yi-Nao An-Shen granule'
Acupuncture group:Acupunture therapy
The combination acupuncture and TCM group:Oral administration of 'Tong-Du Yi-Nao An-Shen granule' and acupunture therapy

Sponsors

Beijing Shunyi Hospital of Traditional Chinese Medicine
Lead Sponsor

Eligibility

Sex/Gender
All

Inclusion criteria

Inclusion criteria: 1. diagnosed as post-stroke insomnia with Qi-stagnation and blood stasis syndrome; 2. aged between 18 and 75 years; 3. Pittsburgh sleep quality index is more than 7 scores; 4. sign the inform consent form.

Exclusion criteria

Exclusion criteria: 1. insomnia happened before ischemic stroke or secondary to others such as systemic disease,pain,fever,surgery,cough, and insomnia symptoms caused by change of life style or environmental interference; 2. patients with sever primary diseases of cardiovascular system, cerebrovascular system, liver, kidney and hematopoietic system; or affective disorders, anxiety disorder, schizophrenia and other sever mental disorders; 3. pregnant or lactating women; 4. alcohol and/or other psychotropic drug abuse or addict; 5. participate in other clinical trials affecting the result evaluation of this study; 6. Been psychiatric medication 2 weeks before recruitment of this study.

Design outcomes

Primary

MeasureTime frame
PSQI;

Secondary

MeasureTime frame
HAMD;HAMA;SS-QOL;

Countries

China

Contacts

Public ContactXuelei Jiao

Beijing Shunyi Hospital of Traditional Chinese Medicine

jxljxl1107@126.com+86 13811960300

Outcome results

None listed

Source: ChiCTR (via WHO ICTRP) · Data processed: Feb 4, 2026