Herbal Medicine 'Eungyosan' and 'Samsoeum' for Common Cold
Primary Purpose
Common Cold
Status
Unknown status
Phase
Not Applicable
Locations
Korea, Republic of
Study Type
Interventional
Intervention
Eungyosan
Samsoeum
Placebo
Sponsored by
About this trial
This is an interventional treatment trial for Common Cold focused on measuring Eungyosan, Samsoeum
Eligibility Criteria
Inclusion Criteria:
- 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
Exclusion Criteria:
- 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
- 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)
Sites / Locations
- Semyung University Korean Medicine Hospital
- Korean Medicine Hospital, Pusan National University
- Korean Medicine Hospital of Daejeon University
- KyungHee University Medical Center
Arms of the Study
Arm 1
Arm 2
Arm 3
Arm Type
Experimental
Experimental
Placebo Comparator
Arm Label
Eungyosan
Samsoeum
Placebo
Arm Description
Dosage is 1 packet, 2.3g, 3 times daily, 6.9g total daily dose. The total duration of administration is up to 8 days.
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.
Take a total of 9.0g, 3.0g each, three times a day. The total duration of administration is up to 8 days.
Outcomes
Primary Outcome Measures
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.
Secondary Outcome Measures
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.
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.
The duration of cold symptoms
The duration of cold symptoms
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.
Full Information
NCT ID
NCT04073511
First Posted
August 28, 2019
Last Updated
August 29, 2019
Sponsor
Korean Medicine Hospital of Pusan National University
1. Study Identification
Unique Protocol Identification Number
NCT04073511
Brief Title
Herbal Medicine 'Eungyosan' and 'Samsoeum' for Common Cold
Official Title
The Effectiveness and Safety of 'Eungyosan' and 'Samsoeum' for Common Cold - a Randomized, Parallel-group, Placebo-controlled, Multicenter Clinical Trial
Study Type
Interventional
2. Study Status
Record Verification Date
August 2019
Overall Recruitment Status
Unknown status
Study Start Date
September 16, 2019 (Anticipated)
Primary Completion Date
December 27, 2020 (Anticipated)
Study Completion Date
December 31, 2020 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Korean Medicine Hospital of Pusan National University
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
5. Study Description
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Common Cold
Keywords
Eungyosan, Samsoeum
7. Study Design
Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
ParticipantInvestigatorOutcomes Assessor
Allocation
Randomized
Enrollment
375 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
Eungyosan
Arm Type
Experimental
Arm Description
Dosage is 1 packet, 2.3g, 3 times daily, 6.9g total daily dose. The total duration of administration is up to 8 days.
Arm Title
Samsoeum
Arm Type
Experimental
Arm Description
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.
Arm Title
Placebo
Arm Type
Placebo Comparator
Arm Description
Take a total of 9.0g, 3.0g each, three times a day. The total duration of administration is up to 8 days.
Intervention Type
Drug
Intervention Name(s)
Eungyosan
Other Intervention Name(s)
Hanpoong Eungyosan
Intervention Description
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.
Intervention Type
Drug
Intervention Name(s)
Samsoeum
Other Intervention Name(s)
Hanpoong Samsoeum
Intervention Description
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.
Intervention Type
Drug
Intervention Name(s)
Placebo
Intervention Description
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.
Primary Outcome Measure Information:
Title
The chance in total WURSS-21-K(Wisconsin Upper Respiratory Symptom Survey-21 Korean version) score
Description
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)
Secondary Outcome Measure Information:
Title
The change in WURSS-21-K(Wisconsin Upper Respiratory Symptom Survey-21 Korean version) symptom score
Description
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)
Title
The change in WURSS-21-K(Wisconsin Upper Respiratory Symptom Survey-21 Korean version quality of life score
Description
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)
Title
The duration of cold symptoms
Description
The duration of cold symptoms
Time Frame
up to 11 days
Title
The change in the VAS(Visual Analogue Scale)
Description
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)
10. Eligibility
Sex
All
Minimum Age & Unit of Time
19 Years
Maximum Age & Unit of Time
60 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
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
Exclusion Criteria:
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
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)
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Jun-Yong Choi, PhD
Phone
82-55-360-5953
Email
kmd@pusan.ac.kr
First Name & Middle Initial & Last Name or Official Title & Degree
Minna Hong, KMD
Email
kmdhminna@gmail.com
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Jun-Yong Choi, PhD
Organizational Affiliation
Korean Medicine Hospital, Pusan National University
Official's Role
Principal Investigator
Facility Information:
Facility Name
Semyung University Korean Medicine Hospital
City
Jecheon
State/Province
Chungcheongbuk-do
ZIP/Postal Code
27136
Country
Korea, Republic of
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Ki Tae Kim
Email
onehorn@daum.net
Facility Name
Korean Medicine Hospital, Pusan National University
City
Yangsan
State/Province
Gyeongsangnam-do
ZIP/Postal Code
50612
Country
Korea, Republic of
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Jun-Yong Choi
Email
kmd@pusan.ac.kr
Facility Name
Korean Medicine Hospital of Daejeon University
City
Daejeon
ZIP/Postal Code
35235
Country
Korea, Republic of
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Yang-Chun Park
Email
omdpyc@dju.ac.kr
Facility Name
KyungHee University Medical Center
City
Seoul
ZIP/Postal Code
02447
Country
Korea, Republic of
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Beom-Joon Lee
Email
franchisjun@naver.com
12. IPD Sharing Statement
Citations:
PubMed Identifier
32071868
Citation
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.
Results Reference
derived
Learn more about this trial
Herbal Medicine 'Eungyosan' and 'Samsoeum' for Common Cold
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