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Table 2 Schedule of Activities that study subjects will go through from beginning to end

From: Randomized, placebo controlled, double blinded pilot superiority phase 2 trial to evaluate the effect of curcumin in moderate to severe asthmatics

Procedures

Screening

Day-7 to -1

Enrollment/baseline

Visit 1, Day 1

Study visit 2

Week 4

Study visit 3

Week 8

Study visit 4

Week 12

Follow up

Week 16

Informed consent

X

     

Demographics

X

     

Medical history

X

     

Randomization

 

X

    

Administer study intervention

 

X

 

Concomitant medication review

X

X

X

X

X

 

Physical exam (including height and weight)

X

X

  

X

 

Vital signs

X

X

  

X

 

ACT Scoring/ Questionnaire

 

X

X

X

X

 

Spirometry (FVC, FEV1)

 

X

X

X

X

 

Blood studies (eosinophils, IgE)

 

X

  

X

 

Exhaled nitric oxide

 

X

X

X

X

 

INR and PTT

 

X

    

Urine pregnancy test (if applicable)

 

X

X

X

X

 

Adverse event review and evaluation

 

X

X

X

X

X

Complete Forms

X

X

X

X

X

X

  1. ACT Asthma control test, FVC forced vital capacity, FEV1 forced expiratory volume in 1 s, IgE immunoglobulin E, INR international normalized ratio, PTT partial thromboplastin time