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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Eungyosan | Experimental | Dosage is 1 packet, 2.3g, 3 times daily, 6.9g total daily dose. The total duration of administration is up to 8 days. |
|
| Samsoeum | Experimental | 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. |
|
| Placebo | Placebo Comparator | Take a total of 9.0g, 3.0g each, three times a day. The total duration of administration is up to 8 days. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Eungyosan | Drug | 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. |
| Measure | Description | Time Frame |
|---|---|---|
| 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. | 6 days (Data collected at different times can be used as a reference) |
| Measure | Description | Time Frame |
|---|---|---|
| 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. |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Jun-Yong Choi, PhD | Contact | 82-55-360-5953 | kmd@pusan.ac.kr | |
| Minna Hong, KMD | Contact | kmdhminna@gmail.com |
| Name | Affiliation | Role |
|---|---|---|
| Jun-Yong Choi, PhD | Korean Medicine Hospital, Pusan National University | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Korean Medicine Hospital, Pusan National University | Yangsan | Gyeongsangnam-do | 50612 | South Korea |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 38033649 | Derived | Kim KI, Hong M, Park YC, Lee BJ, Kim K, Kang BK, Choi JY. Effects of herbal medicines (Eunkyosan/Yin qiao san and Samsoeum/Shen su yin) for treating the common cold: A randomized, placebo-controlled, multicenter clinical trial. Integr Med Res. 2023 Dec;12(4):101005. doi: 10.1016/j.imr.2023.101005. Epub 2023 Oct 26. | |
| 32071868 | Derived |
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| ID | Term |
|---|---|
| D003139 | Common Cold |
| ID | Term |
|---|---|
| D012141 | Respiratory Tract Infections |
| D007239 | Infections |
| D010850 | Picornaviridae Infections |
| D012327 | RNA Virus Infections |
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|
|
| Samsoeum | Drug | 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. |
|
|
| Placebo | Drug | 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. |
|
| 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. | 6 days (Data collected at different times can be used as a reference) |
| The duration of cold symptoms | The duration of cold symptoms | 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. | 6 days (Data collected at different times can be used as a reference) |
| Semyung University Korean Medicine Hospital | Jecheon | North Chungcheong | 27136 | South Korea |
|
| Korean Medicine Hospital of Daejeon University | Daejeon | 35235 | South Korea |
|
| KyungHee University Medical Center | Seoul | 02447 | South Korea |
|
| Kim KI, Hong M, Park YC, Lee BJ, Kim K, Kang BK, Choi JY. Herbal medicines (Eunkyosan and Samsoeum) for treating the common cold: a protocol for a randomized, placebo-controlled, multicenter clinical trial. Integr Med Res. 2020 Mar;9(1):48-53. doi: 10.1016/j.imr.2020.01.009. Epub 2020 Jan 22. |
| D014777 |
| Virus Diseases |
| D012140 | Respiratory Tract Diseases |