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Clinical Trial Protocol for the Behavioral and Imaging Study of the Compound Congrong Yizhi Capsule Intervenes in Mild Cognitive Impairment

Clinical Trial Protocol for the Behavioral and Imaging Study of the Compound Congrong Yizhi Capsule Intervenes in Mild Cognitive Impairment

Status
Active, not recruiting
Phases
Phase 2
Study type
Interventional
Source
ChiCTR
Registry ID
ChiCTR-TRC-12003073
Enrollment
Unknown
Registered
2012-11-05
Start date
2012-11-01
Completion date
Unknown
Last updated
2017-04-18

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

Conditions

Mild cognitive impairment

Interventions

Group B (Control Group):Placebo
Group A(Drug Group):Compound Congrong Yizhi Capsule

Sponsors

Dongfang Hospital
Lead Sponsor

Eligibility

Sex/Gender
All
Age
50 Years to 80 Years

Inclusion criteria

Inclusion criteria: (The following 5 items are required to comply with): (1) Cognitive decline: chief complaint or an insider reports that subject has cognitive impairment problem, and objective examination provides evidence of cognitive impairment; or(and) the objective examination confirmed cognitive function of subject declined over the past; (2) Daily basic living ability must be normal, permits minor damage in the ability of using complex tools; (3) Without dementia; (4) Aged 50 to 80 years; (5) The patient or their legal guardians signed the informed consent.

Exclusion criteria

Exclusion criteria: (Subjects would be exclusive when complied any of the item following) (1) Transient ischemic attack (TIA); (2) Cerebral hemorrhage or subarachnoid hemorrhage; (3) Check confirmed that the stroke was caused by brain tumors,brain trauma and blood diseases; (4) Cerebral embolism caused by atrial fibrillation with rheumatic heart disease, coronary hear t disease or any other heart diseases; (5) Bone and joint diseases and some other serious diseases which were associated with liver, kidney, hematopoietic system and endocrine system etc.; (6) Bone and joint diseases and some other serious diseases which were associated with liver, kidney, hematopoietic system and endocrine system etc.; (7) Mental disorders or severe dementia; (8) Patients can not be performed with MRI which has accepted pacemaker surgery, coronary intervention surgery or coronary artery bypass surgery; (9) Patients can not be performed with MRI which has a magnetic implant inside.

Design outcomes

Primary

MeasureTime frame
Mini-Mental State Examination (MMSE);

Secondary

MeasureTime frame
Auditory Verbal Learning Test;Montreal cognitive assessment(MoCA);Symbol Digit Modalities Test (SDMT);Boston Naming Test;Digit Span;Clock Drawing Test;Stroop test;Trail Making Test;Activities of Daily Living(ADL);

Countries

China

Contacts

Public ContactZHANG Zhan-Jun
zhang_rzs@bnu.edu.cn+86 010 58802005

Outcome results

None listed

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