Randomized controlled trial of Hominis placenta pharmacopuncture on mild cognitive impairment
- Conditions
- Diseases of the nervous system
- Registration Number
- KCT0005368
- Lead Sponsor
- Kyung Hee University
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- ot yet recruiting
- Sex
- All
- Target Recruitment
- 30
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.
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.
Study & Design
- Study Type
- Interventional Study
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method Difference in mean change of MoCA-K scores between intervention group and control group
- Secondary Outcome Measures
Name Time Method 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