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Combination of Yishen Granule and Acupuncture for older adults with mild cognitive impairment: a randomized controlled trial

Combination of Yishen Granule and Acupuncture for older adults with mild cognitive impairment: a randomized controlled trial

Status
Active, not recruiting
Phases
Unknown
Study type
Interventional
Source
ChiCTR
Registry ID
ChiCTR-INR-17011569
Enrollment
Unknown
Registered
2017-06-05
Start date
2018-06-01
Completion date
Unknown
Last updated
2018-03-05

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 A:acupuncture+Yishen Granule
Group B:acupuncture+placebo
Group C:sham acupuncture+Yishen Granule

Sponsors

Shanghai Municipal Hospital of Traditional Chinese Medicine
Lead Sponsor

Eligibility

Sex/Gender
All
Age
65 Years to 85 Years

Inclusion criteria

Inclusion criteria: 1. Aged 65–85 years; 2. Complaint of allomnesia, which can be obtained from an informant who knows the patient well; 3. In addition to memory impairment, other cognitive functions are relatively intact or mildly impaired 4. The cognitive impairment is not severe enough to interfere with daily life; 5. Can't meet the diagnostic criteria for dementia; 6. Without other diseases which can cause brain disorder; 7. GDS score between 2-3, CDR score=0.5, MMSE score>24, DRS score>123, memory test score<1.5 SD according to the age and education matched control group; 8. Able to understand and complete the scale evaluations; 9. Sign the written informed consent form.

Exclusion criteria

Exclusion criteria: 1. Participants who are assessed as normal or dementia by the CDR (Clinical Dementia Rating); 2. Participants with a HAMD (Hamilton Depression Scale) score>8; 3. Participants with schizophrenia, Schizoaffective Disorder, primary affective disorder (including the history of affective disorder), or Participants with severe neural disorder (such as aphasia or agnosia); 4. Participants who were diagnosed as AD, central nervous system infections, post traumatic dementia, toxic encephalopathy, metabolic encephalopathy, Huntington's disease, multiple sclerosis or Parkinson's disease before memory decline, or Participants with untreated primary endocrine disease; 5. Participants with severe primary disease of the cardiovascular, hepatic, renal, or hematopoietic system; 6. Participants suffering from gastrointestinal diseases that affect drug absorption (such as severe dyspepsia, gastrointestinal obstruction or Gastric ulcer); 7. Participants who are allergic to the study granule; 8. Participants who have taken Western and/or Oriental medicine in the past 2 weeks to improve the cognitive function;

Design outcomes

Primary

MeasureTime frame
Montreal Cognitive Assessment;

Secondary

MeasureTime frame
Mini-Mental State Examination;event-related potential;

Countries

China

Contacts

Public ContactJian Xu

Shanghai Municipal Hospital of Traditional Chinese Medicine

0296@szy.sh.cn+86 13901781509

Outcome results

None listed

Source: ChiCTR (via WHO ICTRP) · Data processed: Feb 22, 2026