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. 2019 May 30;20:310. doi: 10.1186/s13063-019-3446-9

Table 2.

The items from the World Health Organization Trial Registration Data Set

Data category Information
Primary registry and trial identifying number CRIS KCT0002896
Date of registration in primary registry 25 May 2018
Sponsor KIOM
Contact for public/scientific queries JHL, KMD, Ph.D (omdjun@kiom.re.kr)
Public title None
Scientific title Neurocircuitry of Acupuncture Effect on Cognitive Improvement in Patients with Mild Cognitive Impairment Using Magnetic Resonance Imaging: A Study Protocol for a Randomized Controlled Trial
Countries of recruitment Republic of Korea
Health condition(s) or problem(s) studied MCI
Intervention(s) Active comparator: acupuncture
Sham comparator: non-penetrating sham acupuncture
Key inclusion and exclusion criteria Ages eligible for study: 50–70 years; sexes eligible for study: both; accepts healthy volunteers: no
Inclusion criteria: diagnosis of MCI, MoCA-K < 23, CDR score of 0.5, GDS grade 2–3
Exclusion criteria: diagnosis of dementia, neurological disorders, mental disorders
Study type Interventional
Allocation: randomized; intervention model: parallel assignment; blinding: subject-assessor blinding
Primary purpose: treatment
Date of first enrolment 18 July 2018
Target sample size 50
Recruitment status Recruiting
Primary outcome(s) DST
Key secondary outcomes DSST, MoCA-K

CRIS Clinical Research Information Service, DSST Digit Symbol Substitution Test, DST Digit Span Test, MCI mild cognitive impairment, MoCA-K Korean version of Montreal Cognitive Assessment, KIOM Korean Institute of Oriental Medicine