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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)
Title | 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) |
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Authors | |
Keywords | Acute Upper Respiratory Tract Infection Fengwen Syndrome Randomized Controlled Trial Shuangjie Capsule Shuangjie Piece |
Issue Date | 2006 |
Citation | Chinese Journal of Evidence-Based Medicine, 2006, v. 6 n. 3, p. 162-170 How to Cite? |
Abstract | Objective: 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 Identifier | http://hdl.handle.net/10722/92194 |
ISSN | 2023 SCImago Journal Rankings: 0.144 |
References |
DC Field | Value | Language |
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dc.contributor.author | Wang, L | en_HK |
dc.contributor.author | Zhang, R-M | en_HK |
dc.contributor.author | Zhao, Y-L | en_HK |
dc.contributor.author | Feng, G-X | en_HK |
dc.contributor.author | Pan, D-J | en_HK |
dc.contributor.author | Huang, X-Y | en_HK |
dc.contributor.author | Mao, B | en_HK |
dc.contributor.author | Wang, G | en_HK |
dc.contributor.author | Chang, J | en_HK |
dc.contributor.author | Zhang, Y | en_HK |
dc.contributor.author | Wan, M-H | en_HK |
dc.contributor.author | Guo, J | en_HK |
dc.contributor.author | Chen, Y | en_HK |
dc.contributor.author | Li, T-Q | en_HK |
dc.date.accessioned | 2010-09-17T10:38:51Z | - |
dc.date.available | 2010-09-17T10:38:51Z | - |
dc.date.issued | 2006 | en_HK |
dc.identifier.citation | Chinese Journal of Evidence-Based Medicine, 2006, v. 6 n. 3, p. 162-170 | en_HK |
dc.identifier.issn | 1672-2531 | en_HK |
dc.identifier.uri | http://hdl.handle.net/10722/92194 | - |
dc.description.abstract | Objective: 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.language | eng | en_HK |
dc.relation.ispartof | Chinese Journal of Evidence-Based Medicine | en_HK |
dc.subject | Acute Upper Respiratory Tract Infection | en_HK |
dc.subject | Fengwen Syndrome | en_HK |
dc.subject | Randomized Controlled Trial | en_HK |
dc.subject | Shuangjie Capsule | en_HK |
dc.subject | Shuangjie Piece | en_HK |
dc.title | 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) | en_HK |
dc.type | Article | en_HK |
dc.identifier.email | Chen, Y:ychenc@hkucc.hku.hk | en_HK |
dc.identifier.authority | Chen, Y=rp1318 | en_HK |
dc.description.nature | link_to_subscribed_fulltext | - |
dc.identifier.scopus | eid_2-s2.0-33645530619 | en_HK |
dc.relation.references | http://www.scopus.com/mlt/select.url?eid=2-s2.0-33645530619&selection=ref&src=s&origin=recordpage | en_HK |
dc.identifier.volume | 6 | en_HK |
dc.identifier.issue | 3 | en_HK |
dc.identifier.spage | 162 | en_HK |
dc.identifier.epage | 170 | en_HK |
dc.identifier.issnl | 1672-2531 | - |