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Table 1 Schedule of enrolment, interventions, and assessments

From: Efficacy and safety of Yi Shen Fang granules in elderly people with MCI: study protocol for a multicentre, randomized, double-blind, parallel-group, controlled trial

 

STUDY PERIOD

STUDY PROCEDURE

Enrolment

Allocation

Post-allocation

Follow-up

TIMEPOINT

-1-week

0-week

4-week

8-week

12-week

24-week

ENROLMENT

 Eligibility screen

 × 

     

 Informed consent

 × 

     

 Allocation

 

 × 

    

INTERVENTIONS

 Intervention group

  

 × 

 × 

  

 Control group

  

 × 

 × 

  

ASSESSMENTSa

 HAMA

 × 

     

 GDS

 × 

     

 CDR

 × 

     

 MoCA

 × 

 × 

 × 

 × 

 × 

 × 

 MES

 × 

 × 

 × 

 × 

 × 

 × 

 FAQ

 × 

 × 

 × 

 × 

 × 

 × 

 TCM symptom scale

 × 

 × 

 × 

 × 

 × 

 × 

 ERP

 

 × 

 

 × 

  

 HCY

 

 × 

 

 × 

  

SAFETY ASSESSMENTS

 Laboratory testsb

 × 

  

 × 

  

Adverse events

  

 × 

 × 

 × 

 × 

  1. aAssessments: HAMA Hamilton Anxiety Scale, GDS Geriatric Depression Scale, CDR Clinical Dementia Rating Scale, MoCA Montreal Cognitive Assessment Score, MES Memory and Executive Screening, FAQ Functional Assessment Questionnaire, TCM Symptom Scale Traditional Chinese Medicine Symptom Scale, ERP event-related-potentials, HCY homocysteine
  2. bLaboratory tests: routine blood, hepatic (ALT alanine aminotransferase, AST aspartate aminotransferase) and renal (BUN blood urea nitrogen, Cr creatinine) functions, urine, faecal and electrocardiogram
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BMC Complementary Medicine and Therapies

ISSN: 2662-7671

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