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Study on intervention effect of BY-HEALTH (R) phosphatidylserine ginkgo biloba leaf soft capsule on the elderly with mild cognitive impairment

Study on intervention effect of BY-HEALTH (R) phosphatidylserine ginkgo biloba leaf soft capsule on the elderly with mild cognitive impairment

Status
Active, not recruiting
Phases
Unknown
Study type
Interventional
Source
ChiCTR
Registry ID
ChiCTR2200058031
Enrollment
Unknown
Registered
2022-03-27
Start date
2022-04-15
Completion date
Unknown
Last updated
2023-11-27

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

Conditions

Mild Cognitive Impairment (MCI)

Interventions

Experimental group:Phosphatidylserine Ginkgo Biloba Soft Capsules (2 capsules/day), orally, for 12 months
Control group:Placebo (2 capsules/day), orally, for 12 months

Sponsors

School of Public Health, Tianjin Medical University
Lead Sponsor

Eligibility

Sex/Gender
All
Age
65 Years to No maximum

Inclusion criteria

Inclusion criteria: 1. Elderly people aged 65 and above in the community; 2. Chief complaint of memory loss for more than 6 months; 3. The score of cognitive ability measured by the Chinese version of MMSE was lower than the standard boundary score of the group according to age and education level; 4. Decreased life and social functions: daily living ability scale score <=18 points; 5. Incapacitated persons who do not meet the diagnostic criteria for dementia, mental illness, brain injury, and other neuropsychiatric states.

Exclusion criteria

Exclusion criteria: 1. Neurological examination showed obvious signs of focal central nervous disorder such as hemiplegia, partial sensory disorder, aphasia, cerebrovascular history (including hemorrhagic and ischemic), internal brain trauma or fracture; 2. Internal diseases such as asthmatic bronchitis, severe hypertension, angina pectoris and severe infection; 3. Patients with obvious depression, anxiety and other mental disorders and history of other endocrine system diseases (such as hyperthyroidism, hypothyroidism, systemic lupus erythematosus, rheumatoid arthritis, etc.); 4. Newly discovered, advanced or advanced tumors; 5. Visual or auditory impairments or verbal communication difficulties that significantly affect cognitive function tests; 6. History of alcohol dependence and abuse of other psychoactive substances (e.g. antipsychotics, benzodiazepines, etc.), or use of drugs that affect cognitive function.

Design outcomes

Primary

MeasureTime frame
Cognitive function (full intelligence quotient);Serum neurotransmitter;alpha-linolenic acid;

Secondary

MeasureTime frame
DHA;EPA;Folate;Related gene expression;Homocysteine;

Countries

China

Contacts

Public ContactHuang Guowei
huangguowei@tmu.edu.cn+86 13752069951

Outcome results

None listed

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