Herbal Medicine 'Eungyosan' and 'Samsoeum' for Common Cold
NCT ID: NCT04073511
Last Updated: 2019-09-03
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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UNKNOWN
NA
375 participants
INTERVENTIONAL
2019-09-16
2020-12-31
Brief Summary
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Detailed Description
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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.
Conditions
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
TRIPLE
Study Groups
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Eungyosan
Dosage is 1 packet, 2.3g, 3 times daily, 6.9g total daily dose. The total duration of administration is up to 8 days.
Eungyosan
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.
Samsoeum
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.
Samsoeum
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
Take a total of 9.0g, 3.0g each, three times a day. The total duration of administration is up to 8 days.
Placebo
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.
Interventions
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Eungyosan
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.
Samsoeum
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
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.
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
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
Exclusion Criteria
2. Those who have chronic respiratory disease (chronic obstructive pulmonary disease, interstitial lung disease) and asthma
3. Those who have taken or should be taking or are taking antibiotics, antivirals, steroids, nasal decongestants, antihistamines, or other medications that are expected to alleviate cold symptoms, or those who have taken food that is expected to relieve cold symptoms within one week of the start of the study
4. Those who are being treated for liver cancer or cirrhosis, chronic renal failure, congestive heart failure, etc.
5. Those who have systemic disease or autoimmune disease which does not affect cold symptoms
6. Those who have severe mental illnesses such as depression or anxiety disorders, or those who are currently taking psychoneurological drugs such as antidepressants
7. Drug addicts or alcoholics
8. Alanine transaminase (ALT) or aspartate transaminase (AST) exceeds 3 times the upper limit of normal
9. Creatinine exceeds twice the upper limit of normal of the research institute
10. Weak person (less than body weight index (BMI) 18.5, clinically judged by Korean medical doctor through physical examination)
11. Those who have a weak stomach and are considered to be inadequate to take investigational drug (clinically judged by Korean medical doctor through physical examination)
12. Those who are with high blood pressure (vital sign measured at upper left after resting for at least 5 minutes at screening: systolic blood pressure ≥160 mmHg or diastolic blood pressure ≥ 100 mmHg) or elderly
13. Those who have cardiac disorder or renal disorder (clinically judged by Korean medical doctor through physical examination, ECG, and serum biochemistry)
14. Those who have histories of hives, rash, or itching while taking medicines
15. Participants in other clinical trials within one month of the start of the trial (30 days prior to the screening visit) or plan to participate in other clinical trials during the trial
16. Pregnant women or women who may be pregnant
17. Those who do not agree to contraception in case of women of childbearing age
18. Those who are being held in group facilities such as social welfare facilities
19. Those who are inappropriate to participate in the trial by the investigator's judgment
20. Those who have hypersensitivity to the investigational drug (main ingredient and its components)
21. Those who have genetic problems such as galactose intolerance, Lapp lactase deficiency, or glucose-galactose malabsorption
22. Those who have hypokalemia
23. Those who have difficulty in daily life due to sweats (excessive sweating, general weakness, etc.)
24. Those who have difficulty in daily life due to anorexia, nausea or vomiting
25. Those who are suspected of having pneumonia and need antibiotic treatment or those who are receiving medical treatment (those receiving other medications)
19 Years
60 Years
ALL
No
Sponsors
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Korean Medicine Hospital of Pusan National University
OTHER
Responsible Party
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Jun-Yong Choi
Associate Professor
Principal Investigators
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Jun-Yong Choi, PhD
Role: PRINCIPAL_INVESTIGATOR
Korean Medicine Hospital, Pusan National University
Locations
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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
Countries
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Central Contacts
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Facility Contacts
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References
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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.
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.
Other Identifiers
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2017012
Identifier Type: -
Identifier Source: org_study_id
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