Clinical study of Huatuo Zaizao pills on nervous dysfunction after cerebral microvascular disease

Phase 4

Recruiting

• Conditions: cerebral microvascular disease

• Registration Number: ITMCTR2100004350
• Lead Sponsor: Beijing Friendship Hospital, Capital Medical University

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Last Update Posted: 20 February 2023

Recruitment & Eligibility

• Status: Recruiting
• Sex: All
• Target Recruitment: Not specified

Inclusion Criteria

Inclusion criteria for cerebral microvascular disease:
(1) Conforming to the imaging diagnosis of cerebral microvascular disease, including lacunar cerebral infarction (LI), leukoencephalopathy (WML) and cerebral microhemorrhage (CMB).
(2) For mild cognitive impairment, refer to rock-Wood diagnostic criteria for vascular cognitive impairment or the diagnostic criteria for vascular dementia jointly established by the National Institute of Neurological Diseases and Stroke and the International Society for Neuroscience Research and Education (NINDS-AIREN).
(3) Ages 40-80 years old.
(4) No heart, liver and kidney dysfunction.
(5) Those who have signed informed consent forms with the patients and their family members,and have been examined and approved by the medical Ethics Committee of the hospital;
Cognitive impairment (MCI) group: combined with mild cognitive impairment on the basis of the above criteria.
Vascular Parkinson's disease (PD) group:combined with extrapyramidal symptoms on the basis of the above criteria,which is considered to be related to cerebral microvascular disease.

Exclusion Criteria

(1) Previous history of chronic pain;
(2) Patients with cerebral hemorrhage or hemorrhagic cerebral infarction;
(3) Patients with various types of dementia;
(4) Pregnant or lactating women;
(5) Having a history of drug allergy or multiple food allergies;
(6) Patients with concurrent primary diseases such as endocrine system and severe heart, liver, kidney and hematopoietic system.
(7) Combined psychiatric or mood disorders (Hamilton anxiety > 9, Depression > 13).
(8) Participate in other drug clinical trials at the same time.

Study & Design

• Study Type: Interventional study
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Pain scores;MOCA;UPDRS score;h-CRP;ADL;NSE;MMSE;Hcy;