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Article: A multiple center, randomized controlled, double-blinded and double-dummy trial of Shuangjie Capsule (Piece) in the treatment of the acute upper respiratory tract infection (the syndrome of heat attacking the lung and weifen)

TitleA multiple center, randomized controlled, double-blinded and double-dummy trial of Shuangjie Capsule (Piece) in the treatment of the acute upper respiratory tract infection (the syndrome of heat attacking the lung and weifen)
Authors
KeywordsAcute Upper Respiratory Tract Infection
Fengwen Syndrome
Randomized Controlled Trial
Shuangjie Capsule
Shuangjie Piece
Issue Date2006
Citation
Chinese Journal of Evidence-Based Medicine, 2006, v. 6 n. 3, p. 162-170 How to Cite?
AbstractObjective: To assess the effectiveness and safety of Shuangjie Capsule (Piece) in the treatment of acute upper respiratory tract infection. Methods: The multiple center, double-blinded, double-dummy and randomized controlled method was adopted to observe 770 patients who were divided into the treatment group A (n=330, treated with Shuangjie Capsule 3 pieces tid), treatment group B (n=330, treated with Shuangjie Piece 3 pieces tid) and the control group (n=110, treated with Chaihuang Piece 3 pieces tid). The therapeutic course for three groups was 5 days. Results: Among 770 included patients, 724 and 718 were screened for intention to treat (ITT) and per-protocol population set (PPS) analysis, respectively. For the effectiveness on upper respiratory tract infection, in treatment group A, the markedly effective rate were 83.60% (ITT) and 84.69% (PPS) respectively, and effective rate were 98.39% (ITT) and 99.02% (PPS) respectively; in treatment group B, the markedly effective rate were 83.28% (ITT) and 83.22% (PPS) respectively, and effective rate were 99.04% (ITT) and 99.03% (PPS) respectively; while in the control group the markedly effective rate were 68.62% and 69.30% respectively, and effective rate were 98.04% and 99.01% respectively. The effectiveness of treatment group were significantly better than that of control group (P<.05). For effects on TCM syndrome, in treatment group A, the markedly effective rate were 83.92% (ITT) and 85.02% (PPS), and effective rate were 98.07% (ITT) and 98.70% (PPS); in treatment group B, the markedly effective rate were 83.92% (ITT) and 83.87% (PPS), and effective rate were 99.36% (ITT) and 99.35% (PPS); while in the control group the markedly effective rate were 74.51% (ITT) and 75.24% (PPS), and effective rate was 98.04% (ITT) and 98.02% (PPS). It also showed a statistical significance between treatment and control group (P<0.05). ITT and PP analysis have the same results. No major adverse effect was found in the observation. Conclusion: Shuangjie Capsule (Piece) shows a definite effect with no obvious toxic-adverse effects.
Persistent Identifierhttp://hdl.handle.net/10722/92194
ISSN
2015 SCImago Journal Rankings: 0.107
References

 

DC FieldValueLanguage
dc.contributor.authorWang, Len_HK
dc.contributor.authorZhang, R-Men_HK
dc.contributor.authorZhao, Y-Len_HK
dc.contributor.authorFeng, G-Xen_HK
dc.contributor.authorPan, D-Jen_HK
dc.contributor.authorHuang, X-Yen_HK
dc.contributor.authorMao, Ben_HK
dc.contributor.authorWang, Gen_HK
dc.contributor.authorChang, Jen_HK
dc.contributor.authorZhang, Yen_HK
dc.contributor.authorWan, M-Hen_HK
dc.contributor.authorGuo, Jen_HK
dc.contributor.authorChen, Yen_HK
dc.contributor.authorLi, T-Qen_HK
dc.date.accessioned2010-09-17T10:38:51Z-
dc.date.available2010-09-17T10:38:51Z-
dc.date.issued2006en_HK
dc.identifier.citationChinese Journal of Evidence-Based Medicine, 2006, v. 6 n. 3, p. 162-170en_HK
dc.identifier.issn1672-2531en_HK
dc.identifier.urihttp://hdl.handle.net/10722/92194-
dc.description.abstractObjective: To assess the effectiveness and safety of Shuangjie Capsule (Piece) in the treatment of acute upper respiratory tract infection. Methods: The multiple center, double-blinded, double-dummy and randomized controlled method was adopted to observe 770 patients who were divided into the treatment group A (n=330, treated with Shuangjie Capsule 3 pieces tid), treatment group B (n=330, treated with Shuangjie Piece 3 pieces tid) and the control group (n=110, treated with Chaihuang Piece 3 pieces tid). The therapeutic course for three groups was 5 days. Results: Among 770 included patients, 724 and 718 were screened for intention to treat (ITT) and per-protocol population set (PPS) analysis, respectively. For the effectiveness on upper respiratory tract infection, in treatment group A, the markedly effective rate were 83.60% (ITT) and 84.69% (PPS) respectively, and effective rate were 98.39% (ITT) and 99.02% (PPS) respectively; in treatment group B, the markedly effective rate were 83.28% (ITT) and 83.22% (PPS) respectively, and effective rate were 99.04% (ITT) and 99.03% (PPS) respectively; while in the control group the markedly effective rate were 68.62% and 69.30% respectively, and effective rate were 98.04% and 99.01% respectively. The effectiveness of treatment group were significantly better than that of control group (P<.05). For effects on TCM syndrome, in treatment group A, the markedly effective rate were 83.92% (ITT) and 85.02% (PPS), and effective rate were 98.07% (ITT) and 98.70% (PPS); in treatment group B, the markedly effective rate were 83.92% (ITT) and 83.87% (PPS), and effective rate were 99.36% (ITT) and 99.35% (PPS); while in the control group the markedly effective rate were 74.51% (ITT) and 75.24% (PPS), and effective rate was 98.04% (ITT) and 98.02% (PPS). It also showed a statistical significance between treatment and control group (P<0.05). ITT and PP analysis have the same results. No major adverse effect was found in the observation. Conclusion: Shuangjie Capsule (Piece) shows a definite effect with no obvious toxic-adverse effects.en_HK
dc.languageengen_HK
dc.relation.ispartofChinese Journal of Evidence-Based Medicineen_HK
dc.subjectAcute Upper Respiratory Tract Infectionen_HK
dc.subjectFengwen Syndromeen_HK
dc.subjectRandomized Controlled Trialen_HK
dc.subjectShuangjie Capsuleen_HK
dc.subjectShuangjie Pieceen_HK
dc.titleA multiple center, randomized controlled, double-blinded and double-dummy trial of Shuangjie Capsule (Piece) in the treatment of the acute upper respiratory tract infection (the syndrome of heat attacking the lung and weifen)en_HK
dc.typeArticleen_HK
dc.identifier.emailChen, Y:ychenc@hkucc.hku.hken_HK
dc.identifier.authorityChen, Y=rp1318en_HK
dc.description.naturelink_to_subscribed_fulltext-
dc.identifier.scopuseid_2-s2.0-33645530619en_HK
dc.relation.referenceshttp://www.scopus.com/mlt/select.url?eid=2-s2.0-33645530619&selection=ref&src=s&origin=recordpageen_HK
dc.identifier.volume6en_HK
dc.identifier.issue3en_HK
dc.identifier.spage162en_HK
dc.identifier.epage170en_HK

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