None listed
Conditions
Interventions
Drug : 1 mL of H. placenta or placebo will be injected twice a week into acupoints (GV20, bilateral ST36, CV12) for 8 weeks.
Sponsors
Kyung Hee University
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: 1) Male or female adult aged 50 to 80. 2) A person diagnosed with mild neurocognitive impairment based on DSM-5. 3) A person who can undergo neuropsychological tests and complete questionnaires. 4) A person who agrees to participate in the trial after receiving explanations regarding the purpose and procedures involved in the clinical trial and has signed the informed consent form by oneself or one’s legal representative. 5) A person with a score of 0.5 on the CDR.
Exclusion criteria
Exclusion criteria: 1) A person with a cranial lesion or brain injury that can cause cognitive decline. 2) A person with a history of cerebral hemorrhage or cerebral infarction. 3) A person with brain diseases such as Parkinson’s disease, epilepsy, and brain cancer. 4) A person with a present illness or past history of a major psychiatric disorder such as schizophrenia, delusional disorder, depressive disorder, bipolar disorder, or alcohol or substance abuse disorder as diagnosed using DSM-5. 5) A person who has participated in other clinical trials within the last one month. 6) A person who had acupuncture treatment for cognitive impairment within the last four weeks. 7) A person who is currently taking medication related to dementia (If the person is diagnosed with MCI and is taking dementia-related drugs, he/she may participate in the clinical trial after the wash-out period of 15 days). 8) A person with a severely destabilizing general medical condition (a doctor in charge will judge the enrollment based on the results of laboratory tests, vital signs, etc.). 9) A person with a clinically serious liver disease or with serum aspartate transaminase and alanine transaminase levels exceeding twice the upper limit of reference value. 10) A person with chronic renal failure or with serum blood urea nitrogen and creatinine levels exceeding 1.5 times the upper limit of reference value. 11) Pregnant woman, lactating woman, or woman of childbearing potential who do not use appropriate methods of contraception. 12) A person who researchers judge to be inappropriate for participation in this clinical trial. 13) A person who is hypersensitive to H. placenta and other drugs. 14) A person with moderate complications other than those involving the heart, liver, and kidney. 15) A person with psychogenic diseases.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Difference in mean change of MoCA-K scores between intervention group and control group | — |
Secondary
| Measure | Time frame |
|---|---|
| Differences in mean change of MMSE-DS, K-DRS, CDR, GDS, K-BDI-II, STAI, STAXI, ISI, EQ-5D, EQ-VAS, and GQOL-D scores between intervention group and control group;Direction of intra-group change of mean of K-DRS, MMSE-DS, MoCA-K, CDR, GDS, K-BDI-II, STAI, STAXI, ISI, EQ-5D, EQ-VAS, and GQOL-D scores in pre- and post-treatment evaluation | — |
Countries
Korea, Republic of
Contacts
Public ContactYunna Kim
Kyung Hee University Oriental Medical Center
Outcome results
None listed