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A randomized controlled, double-blind trial of butylphthalide soft capsules for improving aphasia after cerebral infarction

A randomized controlled, double-blind trial of butylphthalide soft capsules for improving aphasia after cerebral infarction

Status
Recruiting
Phases
Phase 4
Study type
Interventional
Source
ChiCTR
Registry ID
ChiCTR2000040730
Enrollment
Unknown
Registered
2020-12-08
Start date
2020-12-31
Completion date
Unknown
Last updated
2021-05-17

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

Conditions

Aphasia after cerebral infarction

Interventions

Control group:double-blind treatment with placebo
Experimental group:double-blind treatment withbutylphthalide soft capsules

Sponsors

The Second Hospital of Hebei Medical University
Lead Sponsor

Eligibility

Sex/Gender
All

Inclusion criteria

Inclusion criteria: 1) Cerebral infarction diagnosis meets the diagnostic criteria drawn up by the 4th National Cerebrovascular Disease Academic Conference (1996) and is confirmed by brain CT or MRI; 2) Aged >=18 years old; 3) Within 14+/-2 days of the first stroke; 4) Aphasia index score of the Western Aphasia Test Kit<93.8; 5) Those who are conscious and able to cooperate; 6) Primary school education and above; 7) Mother tongue is Chinese; 8) The hand is judged as the right hand; 9) No clear history of cognitive impairment or mental illness before the onset; 10) No serious heart, liver, kidney and other medical and surgical diseases; 11) No other diseases that may seriously affect language function; 12) Those who have no stents, steel nails and other metals in the body, who are not claustrophobic, can complete 1.5T and have MRI scan; 13) Before the start of the study, the patient himself or his legal representative had signed the "Informed Consent".

Exclusion criteria

Exclusion criteria: 1) Cannot communicate in Mandarin or Hebei local dialect; 2) Family history of neurological diseases or hereditary neurological diseases in previous or current patients; 3) Incorporating people with severe cognitive impairment or mental impairment other than language function; 4) Combined with severe hearing or visual impairment; 5) Patients with mental illnesses such as anxiety, depression, split personality, and claustrophobia; 6) People addicted to alcohol or other substances; 7) Intracranial hemorrhagic diseases seen by head CT/MRI: cerebral hemorrhage, subarachnoid hemorrhage (except pseudo subarachnoid hemorrhage), etc., or diseases with hemorrhagic tendency; 8) Patients with iatrogenic stroke caused by interventional diagnosis and treatment of vascular diseases; 9) Complicated with malignant tumor or undergoing anti-tumor treatment; 10) Those who have a history of allergies to celery or Enbipu; 11) Patients during pregnancy, breastfeeding, or who are likely to become pregnant or planning to become pregnant; 12) Participated in other interventional clinical research within 3 months before the date of obtaining informed consent, or is participating in other interventional clinical research; 13) People with severe liver and kidney dysfunction, cardiac dysfunction, peripheral blood disease, or other serious systemic diseases in the past; 14) Patients considered by the researcher to be unsuitable to participate in clinical research.

Design outcomes

Primary

MeasureTime frame
western aphasia battery--Aphasia Quotient;

Countries

China

Contacts

Public ContactXiaoyun Liu

The Second Hospital of Hebei Medical University

audrey-l@163.com+86 13191887318

Outcome results

None listed

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