Efficacy and safety of Maekmoondong-tang for chronic dry cough: a study protocol for a randomized controlled trial

Table 1 Study process: treatment and outcome measurements

Activity	Screening	Visit 1	Visit 2	Visit 3	Follow up
Time schedule	-Week 1	Baseline	Week 2	Week 4	Week 6
Window visit		±3 days	±3 days	±3 days	±3 days
Informed consent	X
Demographics	X
Cough symptom check	X
Medical history	X
Smoking history	X
Medication history	X
Safety test	X	X		X
Chest X-ray	X
Pulmonary function test	X
Safety test	X
Methacholine bronchial challenge test^a	X
Nasal endoscopy^a	X
Distribute cough diary card	X	X	X	X
Randomization		X
Height/weight/body mass index		X
Vital sign		X
Cough diary score		X	X	X	X
Cough visual analogue score		X	X	X	X
Leicester cough ques-tionnaire Korean versi- on		X		X	X
Pattern identification for chronic cough question-naire		X		X
Cold-Heat pattern questionnaire		X		X
Yin deficiency scale		X		X
Hematological biomarker		X		X
Immunologic biomarkers		X		X
Investigational Produce		X	X
Compliance			X	X
Adverse events investi-gation			X	X
Concomitant therapy eva- luation	X	X	X	X

^aThe test will be performed as needed, according to the judgment of the investigator

ISSN: 2662-7671