Acupuncture Combined With Nimodipine for Prevention of Post-stroke Dementia

• Sponsor: Yuzhen Pan (Other)
• Overall Status: Completed
• CT.gov ID: NCT06007573
• Collaborator: Department of acupuncture and massage, Nanling Hospital of traditional Chinese Medicine, Nanling County, Wuhu City, Anhui Province (Other)
• Enrollment: 40
• Location: 1
• Arms: 2
• Actual Duration (Months): 30.4
• Patients Per Site Per Month: 1.3

Study Details

Study Description

Brief 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.

Condition or Disease	Intervention/Treatment	Phase
Post-stroke Dementia	Drug: The control group received oral nimodipine tablets	N/A

Study Design

• Study Type: Interventional
• Actual Enrollment: 40 participants
• Allocation: Randomized
• Intervention Model: Parallel Assignment
• Masking: Single (Outcomes Assessor)
• Primary Purpose: Prevention
• Official Title: Acupuncture Combined With Nimodipine for Prevention of Post-stroke Dementia:a Randomized Controlled Trial
• Actual Study Start Date: Feb 1, 2021
• Actual Primary Completion Date: Aug 1, 2023
• Actual Study Completion Date: Aug 15, 2023

Arms and Interventions

Arm	Intervention/Treatment
Experimental: treatment group On the basis of the control group treatment, the treatment group also adopted the acupuncture treatment	Drug: The control group received oral nimodipine tablets; The control group received oral nimodipine tablets
Other: control group The control group received oral nimodipine tablets	Drug: The control group received oral nimodipine tablets; The control group received oral nimodipine tablets

Outcome Measures

Primary Outcome Measures

1. Response Rate [24 weeks]

Secondary Outcome Measures

1. Hasegawa Dementia Scale [24 weeks]

2. Montreal Cognitive Assessment [24 weeks]

Eligibility Criteria

Criteria

• Ages Eligible for Study: 40 Years to 85 Years
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: No

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

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	The Second Affiliated Hospital of Anhui University of Chinese Medicine	Hefei	Anhui	China	230031

Sponsors and Collaborators

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

Investigators

None specified.

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

• Responsible Party: Yuzhen Pan, DOCTOR, The Second Affiliated Hospital of Anhui University of Traditional Chinese Medicine
• ClinicalTrials.gov Identifier: NCT06007573
• Other Study ID Numbers: 2021-zj-21
• First Posted: Aug 23, 2023
• Last Update Posted: Aug 23, 2023
• Last Verified: Aug 1, 2023

• Individual Participant Data (IPD) Sharing Statement: No
• Plan to Share IPD: No
• Studies a U.S. FDA-regulated Drug Product: No
• Studies a U.S. FDA-regulated Device Product: No
• Keywords provided by Yuzhen Pan, DOCTOR, The Second Affiliated Hospital of Anhui University of Traditional Chinese Medicine: randomized controlled trial; post-stroke dementia; Acupuncture; nimodipine
• Additional relevant MeSH terms: Stroke; Dementia; Nimodipine

Study Results

No Results Posted as of Aug 23, 2023