Efficacy and safety of Yi Shen Fang granules in elderly people with MCI: a multicentre, randomized, double-blind, parallel-group, controlled trial

Phase 1

Recruiting

Conditions: mild cognitive impairment

Registration Number: ITMCTR2000003954

Lead Sponsor: Shanghai Municipal Hospital of Traditional Chinese Medicine,Shanghai University of TCM

Brief Summary: Not available

Detailed Description: Not available

Recruitment & Eligibility

Status: Recruiting

Sex: All

Target Recruitment: Not specified

Inclusion Criteria

1. Male and female participants aged >= 60 years;
2. Clear consciousness, normal hearing and visual abilities are maintained, and have the ability to participate in the neuropsychological activity test;
3. Participants meet diagnostic criteria for MCI in ICD-10 and should meet the following items at the same time:
1) The patient or insider subjectively feels that there is a decline in cognitive function;
2) Impaired cognitive function in objective examination;
3) The daily life function is basically normal;
4. It does not meet the diagnostic criteria of Dementia; The total score of Clinical Dementia Rating Scale (CDR) Chinese version was 0.0 to 0.5;
5. The total score of Montreal Cognitive Assessment (MoCA) Beijing version is below 26 (years of education < 12 years, MOCA score < 25);
6. Participants agree to sign the informed consent form and volunteer for this study.

Exclusion Criteria

(1) Participants with a history of mental disorders such as dissociative disorder, obsessive-compulsive disorder, personality disorder, schizophrenia, bipolar disorder, severe depression disorder, anxiety disorder are excluded;
(2) Participants with a history of drug or alcohol dependence or drug allergies are excluded in this study;
(3) Participants were taking antipsychotic medication or medications that affect cognition;
(4) Participants with a history of head trauma resulting in loss of consciousness;
(5) Any participant on treatment were withdrawn from other clinical drug trials before the first study-drug administration were less than 4 weeks.
(6) Participants with serious gastrointestinal diseases (such as indigestion, gastrointestinal obstruction, gastroduodenal ulceration) and serious secondary diseases that affect drug absorption;
(7) Participants comprised hepatic and renal dysfunctionsevere neurological diseasescardiovascular and cerebrovascular diseases complication as well as a history of other autoimmune diseases and any other contraindication;
(8) Participants with scores of the 30-item version of the Geriatric Depression Scale (GDS-30) higher than 20.
(9) The Hamilton Anxiety Rating Scale (HAMA14-item version) score of >= 21 points.