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Clinical Observation of Shangxia Liangji Dan for the Treatment of Post-Stroke Insomnia (Heart-Kidney Non-Interaction Type) in Ischemic Stroke Patients

A Clinical Observation on the Treatment of Post-Stroke Insomnia (Heart-Kidney Disharmony Type) with Shangxia Liangji Dan

Status
Active, not recruiting
Phases
Unknown
Study type
Interventional
Source
ITMCTR
Registry ID
ITMCTR2026000703
Enrollment
Unknown
Registered
2026-03-24
Start date
2026-03-03
Completion date
Unknown
Last updated
2026-03-30

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

Conditions

Insomnia after ischemic stroke

Interventions

Control Group:Eszopiclone tablets 1 mg orally once daily before bedtime for seven consecutive days.
Treatment group:Shangxia Liangji Dan decoction, twice daily at 400 ml, for seven consecutive days.

Sponsors

Nanhu University Affiliated Nanhu Hospital
Lead Sponsor

Eligibility

Sex/Gender
All
Age
40 Years to 80 Years

Inclusion criteria

Inclusion criteria: (1) Meets the diagnostic criteria for cerebral infarction and insomnia in modern medicine; (2) Meets the diagnostic criteria for stroke and insomnia in traditional Chinese medicine; (3) Meets the criteria for the syndrome of insufficient communication between the heart and kidney in post-stroke insomnia; (4) Has stable and safe vital signs, with no severe diseases such as heart or liver conditions; (5) Is conscious, cooperative during physical examination, with no severe cognitive impairment or inability to cooperate; (6) Had no pathological manifestations such as insomnia before stroke, current insomnia duration =6 months, with a Pittsburgh Sleep Quality Index (PSQI) score >7; (7) Is aged between 40 and 80 years; (8) Has signed the informed consent and is able to cooperate with the treatment.

Exclusion criteria

Exclusion criteria: (1) Those who do not meet the previously described clinical case diagnostic criteria and inclusion criteria; (2) Excluding those with insomnia caused by diseases other than stroke; (3) Excluding those in pregnancy or lactation period; (4) Excluding those with allergic reactions or allergic constitution to the investigational drug.

Design outcomes

Primary

MeasureTime frame
Traditional Chinese Medicine Syndrome Scoring Scale;

Secondary

MeasureTime frame
Clinical Symptoms;

Countries

China

Contacts

Public ContactOuyang Bo

Hunan Province, Hengyang City, Zhuhui District, South Dongfeng Road, Nan Hua University Affiliated Nan Hua Hospital

2094251232@qq.com19918679315

Outcome results

None listed

Source: ITMCTR (via WHO ICTRP) · Data processed: Apr 4, 2026