알레르기 비염 질환자를 대상으로 한 더덕(Codonopsis lanceolata (S. et Z.) Trautv.) 추출물의 과민면역반응 개선에 대한 유효성 및 안전성 평가

• Published in: 大韓本草學會誌 Vol. 34; no. 1; pp. 13 - 21
• Main Authors: 안하영, Ha-young Ahn, 부희옥, Hee-ock Boo, 김형준, Hyeong-jun Kim
• Format: Journal Article
• Language: Korean
• Published: 대한본초학회 01.01.2019
• Subjects: Allergic rhinitis; Codonopsis; Hypersensitivity; Immunity; 한의학; Immunity; Allergic rhinitis; Hypersensitivity; Codonopsis
• ISSN: 1229-1765; 2288-7199
• DOI: 10.6116/kjh.2019.34.1.13

Objectives : This clinical trial is performed to investigate the effect of improving the hypersensitivity reaction and the safety of powdered ethanol extract Codonopsis lanceolata (S. et Z.) Trautv. for allergic patients. Methods : This study was randomized, double blinded, placebo-controlled clinical trial. 60 allergic rhinitis subjects were randomly assigned to Treatment group(n=30) and Control group(n=30). They were received the test substance or placebo in their 1 st and 2 nd visit, and took it once a day, 1 powder bag per 1 time, for 8 weeks. The freeze dried powder of Codonopsis lanceolata (S. et Z.) Trautv. was mixed with 30% ethanol and the filtrate was collected thrice with constant stirring of the mixture. The placebo was prepared in the same form as the test substance by replacing with corn starch. Total Nasal Symptom Score(TNSS) questionnaires and laboratory tests were performed at the screening and last visit to evaluate the efficacy. And to assess safety, vital signs and adverse events were confirmed at every visit. Statistical analysis about the result was performed using SAS 9.4. Results : In treatment group, there was a significant decrease in B cell after taking the test substance(p<0.005). And there was a statistically significant difference between groups(p<0.005). Changes in nasal symptoms were not statistically significant between groups, and both groups showed statistically significant differences before and after the test(p<0.0001). Also there were no adverse events associated with the clinical trial product. Conclusions : This clinical trial showed that Codonopsis lanceolata (S. et Z.) Trautv. extract was helpful in improving the hypersensitivity reaction in allergic patients without significant side effects.