Cognitive improvement effects of Tian Wang Bu Xin Dan (Cheonwangbosimdan) in patients with mild cognitive impairment: protocol for a randomized placebo-controlled pilot clinical trial
Bibliographic record
Abstract
BACKGROUND: It is important to develop effective treatments to prevent the progress of mild cognitive impairment to Alzheimer's disease. Cheonwangbosimdan has been widely prescribed for palpitation, anxiety, insomnia, and memory decline. We aimed to obtain clinical trial data concerning the safety and efficacy of Cheonwangbosimdan for mild cognitive impairment. METHODS: This clinical trial would be a single-center, double-blinded, parallel-arm, prospective, randomized controlled trial. Forty-eight participants with mild cognitive impairment would be randomly allocated evenly to the placebo or Cheonwangbosimdan groups. Participants will be educated on self-management and exercise at baseline and will receive the trial medication (Cheonwangbosimdan group, Cheonwangbosimdan; placebo group, placebo) once daily for 24 weeks. Primary outcome would include the changes in the Montreal Cognitive Assessment scale scores at the end of the intervention. Secondary outcomes would include the changes in the Montreal Cognitive Assessment scale scores at 12 weeks following the first intervention and changes in the scores of the Alzheimer's Disease Assessment Scale-cognitive subscale-3, the European Quality of Life Five Dimension Five Level scale, Korean Instrumental Activities of Daily Living, Korean Activities of Daily Living, and Geriatric Depression Scale at 12 and 24 weeks following the first intervention. DISCUSSION: The results of our trial would provide clinical trial data concerning the usefulness, safety, and efficacy of Cheonwangbosimdan in the management of mild cognitive impairment. TRIAL REGISTRATION: Clinical Research Information Service (Date: November 26, 2021; Registration No. KCT0006787; https://cris.nih.go.kr/cris/search/detailSearch.do?search_lang=E&search_page=M&pageSize=10&page=undefined&seq=20869&status=5&seq_group=20869).
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How this classification was reachedexpand
Full frame machine prediction
Teacher imitationNot calibrated prevalence, not ground truth. Human validation pending. The Gemma side is a direct model label for every work in the frame, read from the title-only record. The Codex side is a classifier learned from the 10,348 direct Codex labels and calibrated to design-weighted sample rates; fields without enough sample support carry no Codex call. Candidate is the union of the two sides; consensus is their intersection. These outputs are machine_predicted_unvalidated and are not human labels.
Distilled classifier scores by category (both heads)
| Category | Codex | Gemma |
|---|---|---|
| Metaresearch | 0.020 | 0.015 |
| Meta-epidemiology (narrow) | 0.006 | 0.003 |
| Meta-epidemiology (broad) | 0.011 | 0.005 |
| Bibliometrics | 0.002 | 0.002 |
| Science and technology studies | 0.004 | 0.004 |
| Scholarly communication | 0.003 | 0.003 |
| Open science | 0.004 | 0.002 |
| Research integrity | 0.007 | 0.007 |
| Insufficient payload (model declined to judge) | 0.041 | 0.007 |
Machine scores (provisional)
The two teacher heads of the student model, read on this work. A score orders the frame for review; it never asserts a category, and the validation status ships verbatim with every row.
Baseline scores from an immature model (maturity gate not passed, 7 training rounds). Scores rank; they never assert a category.
score_only:v0-immature-baseline · verbatim from the scoring run: score_only means the number may rank works, and no category label ships from itClassification
machine, unvalidatedMachine predicted; a candidate call from one source (direct Gemma or distilled Codex), not a consensus.
How this classification was reached, model by model and score by score, is at the end of the page under "How this classification was reached".