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Table 2 Timeline for a randomized trial evaluating fire needle therapy for blood stasis syndrome of plaque psoriasis

From: Efficacy and safety of fire needle therapy for blood stasis syndrome of plaque psoriasis: protocol for a randomized, single-blind, multicenter clinical trial

 

Research cycle

Screening period

Baseline period

Treatment period

Early termination

Follow-up period

Time point

Week 1

Week 0

Week 1

Week 2

Week 3

Week 4

Week 6

Week 8

Enrollment

Inclusion/exclusion criteria

●

●

       

Informed consent

●

        

Demographic characteristics

●

        

Medical history

●

        

Registration

●

        

Randomization

 

●

       

Photographs of skin lesions

 

●

●

●

●

●

●

●

●

Interventions

Basic therapy + fire needle therapy

 

★-------------------------------------------------------------------★

  

Basic therapy + fire needle control therapy

 

☆-------------------------------------------------------------------☆

  

Assessment

PASI

●

●

●

●

●

●

●

●

●

BSA

●

●

●

●

●

●

●

●

●

PGA

●

●

●

●

●

●

●

●

●

DLQI

 

●

●

●

●

●

●

  

PRQoL

 

●

●

●

●

●

●

  

VAS

 

●

●

●

●

●

●

●

●

TCM symptom

 

●

●

●

●

●

●

  

Recurrence rate

       

●

●

Safety

Vital signs

●

●

●

●

●

●

●

●

●

Blood routine

●

    

●

●

  

Blood biochemistry

●

    

●

●

  

Urine routine

●

    

●

●

  

Concomitant medication

●

●

●

●

●

●

●

  

Pregnancy test

●

        

Physical examination

●

    

●

●

●

●

Adverse events

 

●

●

●

●

●

●

●

●

Serious adverse events

●

●

●

●

●

●

●

●

●

  1. PASI Psoriasis Area and Severity Index, BSA body surface area, PGA Physician Global Assessment, DLQI Dermatology Life Quality Index, PRQoL patient-reported quality of life, VAS visual analog scale, TCM traditional Chinese medicine
  2. ★: Fire needle therapy group
  3. ☆: Fire needle control therapy group
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Trials

ISSN: 1745-6215