The investigators intend to conduct a multicenter clinical trial to verify the effectiveness and safety of the administration of 'Eungyosan(EGS)' and 'Samsoeum(SSE)' in cold patients.
375 participants with symptoms of the common cold within 48 h will be recruited for this randomized, placebo-controlled trial. Subjects who will participate in the study will be divided into three groups, 'Eungyosan' group(EGS), 'Samsoeum' group(SSE) and placebo group according to the randomization number. Each group of subjects will take the drugs(EGS or SSE or placebo) 3 times a day up to 8 days. The severity of illness will be assessed by Wisconsin Upper Respiratory Symptom Survey-21 Korean version (WURSS-21-K) and the VAS(visual analog scale) every 8days. Also, the duration of the common cold will be checked to evaluate the effectiveness.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
TRIPLE
Enrollment
375
This drug is a commercially available drug, manufactured according to the Preparation of granules, General rule of formulation, Korean Pharmacopoeia. Dosage is 1 packet, 2.3g, 3 times daily, 6.9g total daily dose. The total duration of administration is up to 8 days.
This drug is a commercially available drug, manufactured according to MFDS regulations and the Preparation of granules, General rule of formulation, Korean Pharmacopoeia. 3.37g of a packet, 3 times a day, the total daily dose is 10.11g. Total duration of administration is up to 8 days.
It is composed of lactose carb, corn starch, caramel pigment, and ginseng flavor powder. It is brown granule and made to be recognized as Korean medicine. Take a total of 9.0g, 3.0g each, three times a day. The total duration of administration is up to 8 days.
Korean Medicine Hospital, Pusan National University
Yangsan, Gyeongsangnam-do, South Korea
Semyung University Korean Medicine Hospital
Jecheon, North Chungcheong, South Korea
Korean Medicine Hospital of Daejeon University
Daejeon, South Korea
KyungHee University Medical Center
Seoul, South Korea
The chance in total WURSS-21-K(Wisconsin Upper Respiratory Symptom Survey-21 Korean version) score
The investigators will assess the primary outcome through the change in total score(symptom score sum quality of life score) of Wisconsin Upper Respiratory Symptom Survey-21 Korean version (WURSS-21-K) 6 days after baseline. WURSS-21, which consists of questionnaires regarding gross severity, symptoms, quality of life, and improvement of illness. All items rank on a seven-point scale(1=very mild and 7=severe), where a higher score means higher severity. The symptom score is from 0(Do not have this symptom) to 70, and quality of life score is from 0(Not at all) to 56. Therefore, the total score ranges from 0 to 126.
Time frame: 6 days (Data collected at different times can be used as a reference)
The change in WURSS-21-K(Wisconsin Upper Respiratory Symptom Survey-21 Korean version) symptom score
The investigators will assess the secondary outcome through the change in symptom score of Wisconsin Upper Respiratory Symptom Survey-21 Korean version (WURSS-21-K) 6 days after baseline. All items of symptom score rank on a seven-point scale(1=very mild and 7=severe), where a higher score means higher severity. The symptom score ranges from 0(Do not have this symptom) to 70.
Time frame: 6 days (Data collected at different times can be used as a reference)
The change in WURSS-21-K(Wisconsin Upper Respiratory Symptom Survey-21 Korean version quality of life score
The investigators will assess the secondary outcome through the change in quality of life score of Wisconsin Upper Respiratory Symptom Survey-21 Korean version (WURSS-21-K) 6 days after baseline. All items of quality of life score rank on a seven-point scale(1=very mildly and 7=severely), where a higher score means higher severity. The quality of life score ranges from 0(Not at all) to 56.
Time frame: 6 days (Data collected at different times can be used as a reference)
The duration of cold symptoms
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The duration of cold symptoms
Time frame: up to 11 days
The change in the VAS(Visual Analogue Scale)
The investigators will assess the secondary outcome through the change in the VAS(Visual analog scale) 6 days after baseline, using EuroQol-visual analog scales(EQ-VAS). The EQ-VAS is a vertical visual analog scale that takes values between 100 (best imaginable health) and 0 (worst imaginable health), on which participants provide a global assessment of their health.
Time frame: 6 days (Data collected at different times can be used as a reference)