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 sites128 target enrollmentTBD

Overview

No summary available.

Registry

who.int

Start Date

TBD

End Date

February 19, 2021

Last Updated

4 years ago

Study Type

Interventional Study

Sex

All

Sponsor

Pusan National University Korean Medicine Hospital

•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

•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)