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

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

Status
Recruiting
Phases
Early Phase 1
Study type
Interventional
Source
ChiCTR
Registry ID
ChiCTR2000036807
Enrollment
Unknown
Registered
2020-08-25
Start date
2021-04-01
Completion date
Unknown
Last updated
2021-04-12

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

Conditions

mild cognitive impairment

Interventions

Sponsors

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

Eligibility

Sex/Gender
All
Age
60 Years to No maximum

Inclusion criteria

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

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Participants with a history of head trauma resulting in loss of consciousness; (5) Any participant on treatment were withdrawn from other clinical drug trials before the first study-drug administration were less than 4 weeks.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.

Design outcomes

Primary

MeasureTime frame
MoCA;MES;

Secondary

MeasureTime frame
FAQ;Record cognitive event-related potential ERP;Detection of homocysteine;

Countries

China

Contacts

Public ContactXu Jian

Shanghai Municipal Hospital of Traditional Chinese Medicine, Shanghai University of TCM

xujian0296@163.com+86 13901781509

Outcome results

None listed

Source: ChiCTR (via WHO ICTRP) · Data processed: Feb 11, 2026