The Effectiveness and Safety of 'Eungyosan' and 'Samsoeum' for Common Cold - a Randomized, Parallel-group, Placebo-controlled, Multicenter Clinical Trial
试验速览
- 阶段
- 不适用
- 发起方
- 入组人数
- 375
- 试验地点
- 4
- 主要终点
- The chance in total WURSS-21-K(Wisconsin Upper Respiratory Symptom Survey-21 Korean version) score
研究概览
简要总结
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.
详细描述
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.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- Triple (Participant, Investigator, Outcomes Assessor)
入排标准
- 年龄范围
- 19 Years 至 60 Years（Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •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
排除标准
- •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)
研究组 & 干预措施
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.
干预措施: Eungyosan (Drug)
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.
干预措施: Samsoeum (Drug)
Placebo
Take a total of 9.0g, 3.0g each, three times a day. The total duration of administration is up to 8 days.
干预措施: Placebo (Drug)
结局指标
主要结局
The chance in total WURSS-21-K(Wisconsin Upper Respiratory Symptom Survey-21 Korean version) score
时间窗: 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.
次要结局
- The change in WURSS-21-K(Wisconsin Upper Respiratory Symptom Survey-21 Korean version) symptom score(6 days (Data collected at different times can be used as a reference))
- The duration of cold symptoms(up to 11 days)
- The change in WURSS-21-K(Wisconsin Upper Respiratory Symptom Survey-21 Korean version quality of life score(6 days (Data collected at different times can be used as a reference))
- The change in the VAS(Visual Analogue Scale)(6 days (Data collected at different times can be used as a reference))
研究者
Jun-Yong Choi
Associate Professor
Korean Medicine Hospital of Pusan National University