Common Cold
Conditions
Keywords
Eungyosan, Samsoeum
Brief summary
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.
Detailed description
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.
Interventions
DRUGEungyosan
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.
DRUGSamsoeum
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.
DRUGPlacebo
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.
Sponsors
Korean Medicine Hospital of Pusan National University
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
TRIPLE (Subject, Investigator, Outcomes Assessor)
Eligibility
Sex/Gender
ALL
Age
19 Years to 60 Years
Healthy volunteers
No
Inclusion criteria
1. Male and female aged between 19 and 60 years as of the screening date 2. Onset of cold symptoms within 48 hours before screening 3. Those who have one or more of the symptoms and related symptoms of runny nose and sore throat (Related symptoms: nasal congestion, sneezing, sore throat, cough, sore throat, headache, chest tightness, fatigue) 4. Those who demonstrate understanding of the study details and have willingness to participate as evidenced by voluntary written informed consent 5. Those who can be followed up during the clinical trial 6. Those who do not meet the
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| The chance in total WURSS-21-K(Wisconsin Upper Respiratory Symptom Survey-21 Korean version) score | 6 days (Data collected at different times can be used as a reference) | 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. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| The change in WURSS-21-K(Wisconsin Upper Respiratory Symptom Survey-21 Korean version) symptom score | 6 days (Data collected at different times can be used as a reference) | 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. |
| The change in WURSS-21-K(Wisconsin Upper Respiratory Symptom Survey-21 Korean version quality of life score | 6 days (Data collected at different times can be used as a reference) | 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. |
| The duration of cold symptoms | up to 11 days | The duration of cold symptoms |
| The change in the VAS(Visual Analogue Scale) | 6 days (Data collected at different times can be used as a reference) | 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. |
Countries
South Korea
Contacts
Primary ContactJun-Yong Choi, PhD
Backup ContactMinna Hong, KMD
Outcome results
None listed