KCT0006307已完成未知
Efficacy, safety and economic evaluation of Eun-kyo-san and Sam-so-eum on common cold: randomized, placebo controlled, multicenter trail
Pusan National University Korean Medicine Hospital0 个研究点目标入组 128 人开始时间: 待定最近更新:
试验速览
- 阶段
- 未知
- 状态
- 已完成
- 发起方
- 入组人数
- 128
研究概览
简要总结
暂无简介。
研究设计
- 研究类型
- Interventional Study
入排标准
- 年龄范围
- 19?(Year) 至 60?(Year)（—）
- 性别
- All
入选标准
- •1. Men and women aged 19 to 60 as of the screening date
- •2. Who is diagnosed with a cold and whose symptoms are within 48 hours before clinical trial begins
- •3. Those who have one or more additional symptoms related to runny nose and sore throat (related symptoms: stuffy nose, sneezing, sore throat, coughing, hoarse throat, headache, stuffy chest, tiredness)
- •4. A person who has fully understood the detailed explanation of this clinical trial, decides to participate voluntarily, and agrees in writing to comply with the precautions
- •5. A person who can be monitored during the clinical trial period
- •6. Persons not included in the exclusion criteria
排除标准
- •1. People suffering from sinusitis (transillumination of maxillary and frontal regions), allergic rhinitis, pneumonia, flu (cough or sore throat with sudden fever above 38°C), bronchitis, middle ear inflammation, and tonsillitis (pNS view if correct examination is required)
- •2. Chronic respiratory disease (chronic obstructive pulmonary disease, epileptic pulmonary disease) and asthma sufferers
- •3. If you have taken antibiotics, antivirals, steroids, non-infectious drugs, anti-histamines, or other medications that are expected to alleviate cold symptoms within one week of the test start date, or if you have taken them, or if you have taken food that is expected to alleviate cold symptoms.
- •4. A person who is being treated for liver cancer or cirrhosis, chronic kidney failure, congestive heart failure, etc.;
- •5. A person who has no effect on cold symptoms but has a systemic or autoimmune disease.
- •6. A person who has severe mental illness, such as depression or anxiety disorder, or is currently taking drugs for the mental nervous system, such as antidepressants;
- •7. Drugs or alcoholics
- •8. A person whose ALT (Alanine transaminase) or AST (Aspartate transaminase) exceeds three times the normal upper limit of the institution.
- •9. A person whose creatinine exceeds twice the normal upper limit of a research institute
- •10. A person with a weak body (below BMI 18.5, clinically judged by an oriental medical doctor through a scientific examination)
- •11. A person who is considered inappropriate to take clinical trial medications due to his/her weak stomach (clinically judged by an oriental medical doctor through a scientific examination)
- •12. Patients with high blood pressure (at screening, systolic blood pressure =160 mmHg or relaxation pressure = 100 mg) or elderly people at vital signs measured from the left or left after a rest of at least 5 minutes.
- •13. Patients with heart or kidney impairment (clinically determined by an oriental medical doctor through a scientific examination, electrocardiogram, and serum biochemical examination)
- •14. Patients who have experienced hives, redness, or itching while taking medication so far
- •15. A person who has participated in another clinical trial within one month prior to the commencement of this trial (30 days prior to the date of the screening visit) or plans to participate in another clinical trial during the trial period.
- •16. A woman who is pregnant or possibly pregnant
- •17. A woman of childbearing age who disagrees with contraception
- •18. Persons who are housed in collective facilities, such as social welfare facilities;
- •19. Any other person deemed inappropriate by the judgment of the tester;
- •20. Patients with genetic problems such as galactose intolerance, Lap lactase deficiency, or glucose-galactose malabsorption.
- •21. Persons with hypersensitivity to clinical trial medications (main ingredients and their components)
- •22. A person with hypokalemia
- •23. Patients who sweat so much that their daily lives are difficult (excessive sweating, general lethargy, etc.)
- •24. A person who has difficulty in daily life due to poor appetite, nausea, and vomiting;
- •25. A person who is suspected of pneumonia and is deemed to need antibiotic treatment or who is receiving medical treatment (someone who is receiving other medications)
研究者
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