Status:
UNKNOWN
Herbal Medicine 'Eungyosan' and 'Samsoeum' for Common Cold
Lead Sponsor:
Korean Medicine Hospital of Pusan National University
Conditions:
Common Cold
Eligibility:
All Genders
19-60 years
Phase:
NA
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 gro...
Eligibility Criteria
Inclusion
- 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
- 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)
Key Trial Info
Start Date :
September 16 2019
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
December 31 2020
Estimated Enrollment :
375 Patients enrolled
Trial Details
Trial ID
NCT04073511
Start Date
September 16 2019
End Date
December 31 2020
Last Update
September 3 2019
Active Locations (4)
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1
Korean Medicine Hospital, Pusan National University
Yangsan, Gyeongsangnam-do, South Korea, 50612
2
Semyung University Korean Medicine Hospital
Jecheon, North Chungcheong, South Korea, 27136
3
Korean Medicine Hospital of Daejeon University
Daejeon, South Korea, 35235
4
KyungHee University Medical Center
Seoul, South Korea, 02447