Acupuncture Combined With Nimodipine for Prevention of Post-stroke Dementia

Post-stroke Dementia Clinical Trial

Official title:

Acupuncture Combined With Nimodipine for Prevention of Post-stroke Dementia:a Randomized Controlled Trial

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT06007573
• Other study ID #: 2021-zj-21
• Status: Completed
• Phase: N/A
• Start date: February 1, 2021
• Est. completion date: August 15, 2023

Study information

• Verified date: August 2023
• Source: The Second Affiliated Hospital of Anhui University of Traditional Chinese Medicine
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

To observe the clinical efficacy of TCM acupuncture combined with western medicine nimodipine for prevention of post-stroke dementia by comparing with clinical conventional treatment methods.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 40
• Est. completion date: August 15, 2023
• Est. primary completion date: August 1, 2023
• Accepts healthy volunteers: No
• Gender: All
• Age group: 40 Years to 85 Years

Eligibility

Inclusion Criteria:

1. Definite ischemic stroke or hemorrhagic stroke confirmed by head CT / MRI examination

2. Memory or cognitive and executive dysfunction. Cognitive dysfunction will be determined after the mini mental state evaluation (MMSE) score

3. Age limited to 40-85 years, irrespective of gender

4. Stable condition, clear consciousness, no aphasia, oral medication available

5. No major comorbidity, no major depression

6. Consent and signed patient informed consent

Exclusion Criteria:

1. Had serious medical conditions, such as heart, liver, kidney, or endocrine disease

2. Aphasia or hearing impairment

3. Participants in other clinical trials

4. Patients currently on medication to improve cognitive function

Related Conditions & MeSH terms

• Dementia
• Post-stroke Dementia
• Stroke

Intervention

Drug:
• The control group received oral nimodipine tablets
The control group received oral nimodipine tablets

Locations

Country	Name	City	State
China	The Second Affiliated Hospital of Anhui University of Chinese Medicine	Hefei	Anhui

Sponsors (2)

Lead Sponsor	Collaborator
Yuzhen Pan	Department of acupuncture and massage, Nanling Hospital of traditional Chinese Medicine, Nanling County, Wuhu City, Anhui Province

Country where clinical trial is conducted

China, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Response Rate		24 weeks
Secondary	Hasegawa Dementia Scale		24 weeks
Secondary	Montreal Cognitive Assessment		24 weeks