Common ColdNCT04073511
Herbal Medicine 'Eungyosan' and 'Samsoeum' for Common Cold
A study testing Eungyosan and Samsoeum in people with Common Cold, run by Korean Medicine Hospital of Pusan National University at 4 sites in South Korea.
Trial 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. Read more about this study
- Who is it for?
- Ages 19 to 60 years
- Conditions the study is for
- Common Cold
- What is being tested?
- Eungyosan and Samsoeum
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 375 participants
- Where
- 4 sitesSouth Korea
- Study dates
- 16 Sep 2019to 31 Dec 2020
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 19 to 60 years
- All sexes
- No healthy volunteers
- Adult
Who may be able to join
- Male and female aged between 19 and 60 years as of the screening date
- Onset of cold symptoms within 48 hours before screening
- 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)
- Those who demonstrate understanding of the study details and have willingness to participate as evidenced by voluntary written informed consent
- Those who can be followed up during the clinical trial
- Those who do not meet the exclusion criteria
Who cannot join
- Those who have sinusitis (when the sinus is opaque at the time of examination through the transillumination of the maxillary sinus and the frontal sinus), allergic rhinitis, pneumonia, flu (when coughing or sore throat with sudden fever above 38 ℃), bronchitis, otitis media, tonsillitis (PNS view, Chest Xray test if accurate test is needed)
- Those who have chronic respiratory disease (chronic obstructive pulmonary disease, interstitial lung disease) and asthma
- 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
- Those who are being treated for liver cancer or cirrhosis, chronic renal failure, congestive heart failure, etc.
- Those who have systemic disease or autoimmune disease which does not affect cold symptoms
- Those who have severe mental illnesses such as depression or anxiety disorders, or those who are currently taking psychoneurological drugs such as antidepressants
Show all 25Show fewer
- Drug addicts or alcoholics
- Alanine transaminase (ALT) or aspartate transaminase (AST) exceeds 3 times the upper limit of normal
- Creatinine exceeds twice the upper limit of normal of the research institute
- Weak person (less than body weight index (BMI) 18.5, clinically judged by Korean medical doctor through physical examination)
- 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)
- 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
- Those who have cardiac disorder or renal disorder (clinically judged by Korean medical doctor through physical examination, ECG, and serum biochemistry)
- Those who have histories of hives, rash, or itching while taking medicines
- 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
- Pregnant women or women who may be pregnant
- Those who do not agree to contraception in case of women of childbearing age
- Those who are being held in group facilities such as social welfare facilities
- Those who are inappropriate to participate in the trial by the investigator's judgment
- Those who have hypersensitivity to the investigational drug (main ingredient and its components)
- Those who have genetic problems such as galactose intolerance, Lapp lactase deficiency, or glucose-galactose malabsorption
- Those who have hypokalemia
- Those who have difficulty in daily life due to sweats (excessive sweating, general weakness, etc.)
- Those who have difficulty in daily life due to anorexia, nausea or vomiting
- Those who are suspected of having pneumonia and need antibiotic treatment or those who are receiving medical treatment (those receiving other medications)
Trial locations and contacts
4 sites in 1 country.
Minna Hong, KMD contact
South Korea4 sites
Korean Medicine Hospital of Daejeon University
Daejeon, 35235
Yang-Chun Park, omdpyc@dju.ac.kr
Semyung University Korean Medicine Hospital
Jecheon, North Chungcheong, 27136
Ki Tae Kim, onehorn@daum.net
KyungHee University Medical Center
Seoul, 02447
Beom-Joon Lee, franchisjun@naver.com
Korean Medicine Hospital, Pusan National University
Yangsan, Gyeongsangnam-do, 50612
Jun-Yong Choi, kmd@pusan.ac.kr
About this study
Official title: The Effectiveness and Safety of 'Eungyosan' and 'Samsoeum' for Common Cold - a Randomized, Parallel-group, Placebo-controlled, Multicenter Clinical Trial
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.
Read the 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.
- Conditions
- Common Cold
- Being tested
- Eungyosan, Samsoeum, Placebo
- Keywords
- Eungyosan, Samsoeum
- Medical subject headings
- Common Cold
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
EungyosanDrug
Also called Hanpoong 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.
SamsoeumDrug
Also called Hanpoong 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.
PlaceboDrug
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.
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: Drug: Eungyosan |
| 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. Receives: Drug: Samsoeum |
| 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. Receives: Drug: Placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 6 days (Data collected at different times can be used as a reference)
Secondary outcomes (4)
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.
Measured: 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.
Measured: 6 days (Data collected at different times can be used as a reference)
The duration of cold symptoms
The duration of cold symptoms
Measured: 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.
Measured: 6 days (Data collected at different times can be used as a reference)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted29 Aug 2019
- Study start16 Sep 2019 (estimated)
- Primary completion27 Dec 2020 (estimated)
- Study completion31 Dec 2020 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (2)Papers the sponsor has linked to this study.
- Other trials for Common ColdStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind
- Who is masked
- Participant, Investigator, Outcomes assessor
- Enrolment
- 375 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Korean Medicine Hospital of Pusan National University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Jun-Yong Choi, Korean Medicine Hospital of Pusan National University
- Investigators
- Jun-Yong Choi, PhD, Principal investigator, Korean Medicine Hospital, Pusan National University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04073511
- Sponsor's protocol ID
- 2017012
- Status last verified
- Aug 2019
- First submitted
- 28 Aug 2019
- Last updated
- 3 Sep 2019
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Publications
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.
PubMed 38033649Kim 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.
PubMed 32071868
Study at a glance
From the registry record, last updated by the sponsor on 3 Sep 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Effectiveness and Safety of 'Eungyosan' and 'Samsoeum' for Common Cold - a Randomized, Parallel-group, Placebo-controlled, Multicenter Clinical Trial
- ClinicalTrials.gov ID
- NCT04073511
- Acronym / sponsor ID
- 2017012
- Conditions
- Common Cold
- Keywords
- Eungyosan, Samsoeum
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 375 participants (estimated)
- Lead sponsor
- Korean Medicine Hospital of Pusan National UniversityUniversity, hospital or other
- Study start
- 16 Sep 2019 (estimated)
- Primary completion
- 27 Dec 2020 (estimated)
- Study completion
- 31 Dec 2020 (estimated)
- First posted
- 29 Aug 2019 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind (participant, investigator, outcomes assessor)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Eungyosan | Experimental | Drug: EungyosanDosage 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 | Drug: Samsoeum3.37g 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 | Drug: PlaceboTake a total of 9.0g, 3.0g each, three times a day. The total duration of administration is up to 8 days. |
Who may qualify
- Ages
- 19 to 60 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (6 listed)
- Male and female aged between 19 and 60 years as of the screening date
- Onset of cold symptoms within 48 hours before screening
- 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)
- Those who demonstrate understanding of the study details and have willingness to participate as evidenced by voluntary written informed consent
- Those who can be followed up during the clinical trial
Key exclusion criteria (25 listed)
- Those who have sinusitis (when the sinus is opaque at the time of examination through the transillumination of the maxillary sinus and the frontal sinus), allergic rhinitis, pneumonia, flu (when coughing or sore throat with sudden fever above 38 ℃), bronchitis, otitis media, tonsillitis (PNS view, Chest Xray test if accurate test is needed)
- Those who have chronic respiratory disease (chronic obstructive pulmonary disease, interstitial lung disease) and asthma
- 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
- Those who are being treated for liver cancer or cirrhosis, chronic renal failure, congestive heart failure, etc.
- Those who have systemic disease or autoimmune disease which does not affect cold symptoms
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| EungyosanAlso: Hanpoong EungyosanThis 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. | Drug | Eungyosan |
| SamsoeumAlso: Hanpoong SamsoeumThis 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. | Drug | Samsoeum |
| PlaceboIt 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. | Drug | Placebo |
Primary outcome
The chance in total WURSS-21-K(Wisconsin Upper Respiratory Symptom Survey-21 Korean version) score
Time frame: 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.
4 secondary outcomes
The change in WURSS-21-K(Wisconsin Upper Respiratory Symptom Survey-21 Korean version) symptom score
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
Time frame: 6 days (Data collected at different times can be used as a reference)
The duration of cold symptoms
Time frame: up to 11 days
The change in the VAS(Visual Analogue Scale)
Time frame: 6 days (Data collected at different times can be used as a reference)
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 3 Sep 2019.
- Derived from this study: PubMed 38033649Kim 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.
- Derived from this study: PubMed 32071868Kim 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.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Minna Hong, KMD contact
Jun-Yong Choi, PhD principal investigator
Korean Medicine Hospital, Pusan National University
4 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Eungyosan and Samsoeum in people with Common Cold, run by Korean Medicine Hospital of Pusan National University at 4 sites in South Korea.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 6 inclusion and 25 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 3 Sep 2019. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 4 sites in South Korea. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Jun-Yong Choi, PhD (82-55-360-5953, kmd@pusan.ac.kr), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
The chance in total WURSS-21-K(Wisconsin Upper Respiratory Symptom Survey-21 Korean version) score (time frame: 6 days (Data collected at different times can be used as a reference)). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT04073511, which also lists 2 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 3 Sep 2019.