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A randomized, blind and controlled study of tonifying kidney, invigorating spleen and reducing phlegm in the treatment of amnestic mild cognitive impairment

A randomized, blind and controlled study of tonifying kidney, invigorating spleen and reducing phlegm in the treatment of amnestic mild cognitive impairment

Status
Recruiting
Phases
Phase 1
Study type
Interventional
Source
ITMCTR
Registry ID
ITMCTR2100005393
Enrollment
Unknown
Registered
2021-12-11
Start date
2021-12-15
Completion date
Unknown
Last updated
2023-02-20

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

Conditions

Mild cognitive ment

Interventions

Control group:Placebo
Treatment Group:Chinese medicine granule

Sponsors

Beijing Friendship Hospital, Capital Medical University
Lead Sponsor

Eligibility

Sex/Gender
All
Age
18 Years to 85 Years

Inclusion criteria

Inclusion criteria: (1) Meet the diagnostic criteria of mild cognitive impairment in this study; (2) The chief complaint was memory loss, which was confirmed by the surrounding people; (3) Aged between 45 and 85; (4) The MMSE ranged from 24 to 30 points; (5) age-inconsistent objective memory decreased, and delayed recall score of logical story recall was 1.5 SD (SD) to 2SD (SD) smaller than that of age or education matched group. (6) The ability of daily living is basically normal, and the severity of dementia is not up to the diagnostic criteria; (7) Heginsky ischemia Scale (HIS) score was 7 or less; (8) Hamilton Depression Scale (HAMD) score of 12 or below; (9) The standard of TCM syndrome diagnosis is pES-11, namely, at least one of the three syndromes of kidney eficiency, spleen deficiency and phlegm turbidity =7 points; (10) Have a certain degree of education, can read simple articles, write simple sentences; (11) Adequate hearing and vision assessment; (12) Subjects and caregivers are willing to sign informed consent.

Exclusion criteria

Exclusion criteria: (1) The presence of any neurological disease causing dementia, such as Parkinson's disease, multisystem atrophy, progressive supranuclear palsy, Huntington's disease, vascular dementia, normal pressure hydrocephalus, brain tumors, epilepsy, cerebral edema after cerebral hemorrhage before absorption or subarachnoid hemorrhage in the acute phase, chronic subdural hematoma and multiple sclerosis, A history of severe head trauma with persistent neurological deficits or known brain structural abnormalities; (2) The presence of clinically uncontrolled cardiovascular and cerebrovascular diseases, abnormal liver and kidney metabolism diseases, peptic ulcer active stage; (3) Depressive state (HAMD>7), or other mental disorders; (4) thyroid dysfunction, significant Vb12 or folic acid deficiency; (5) had taken antipsychotic drugs within 72 hours before the neuropsychological assessment; (6) Had taken sympathomimetic drugs, antihistamines, antianxiety drugs and diazepam within 48 hours before the neuropsychological assessment; (7) History of alcohol addiction and abuse; (8) Those who have serious neurological defects and cannot complete relevant examinations, such as convenient hand hemiplegia, various aphasia, audio-visual impairment, etc.

Design outcomes

Primary

MeasureTime frame
PES-1;ADAS-Cog;MMSE;

Contacts

Public Contactwudongyue
wudongyue62@163.com13811048577

Outcome results

None listed

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