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Journal of Chinese Integrative Medicine ›› 2007, Vol. 5 ›› Issue (2): 141-146.doi: 10.3736/jcim20070208

• Original Clinical Research • Previous Articles     Next Articles

A double-blind, randomized controlled trial of Chaige Qingre Granule in treating acute upper respiratory tract infection of wind heat syndrome

Jing Chang, Ying Zhang, Bing Mao, Lei Wang, Ting-qian Li, Rui-ming Zhang   

  1. Department of Integrated Chinese and Western Medicine, West China Hospital, Sichuan University, Chengdu, Sichuan Province 610041, China
  • Online:2007-03-31 Published:2007-03-15

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Objective: To evaluate the safety and efficacy of Chaige Qingre Granule, a traditional Chinese compound herbal medicine, in treating acute upper respiratory tract infection of wind heat syndrome. 

Methods: A multi-center, double-blinded, randomized controlled trial was conducted. In the phase Ⅱ, 60 patients with acute upper respiratory tract infection were randomly divided into the trial group (n=30) and the control group (n=30). In the phase Ⅲ, 112 patients were randomly divided into the trial group (n=84) and the control group (n=28). The trial group received 6 g Chaige Qingre Granule, and the control group received 6 g Fufang Shuanghua Granule (another traditional Chinese compound herbal medicine). The two groups were all treated for 3 days and four times daily. Clinical symptoms, syndromes, adverse effect, blood, urine and stool test, hepatorenal function and electrocardiogram were examined before and after the treatment. 

Results: After treatment, the overall obvious response rates of the trial group and the control group were 78.57%, 82.14% (by per-protocol analysis) and 75.86%, 79.31% (by intention-to-treat analysis) respectively, and the overall response rates of the two groups were 96.43%, 100% (by per-protocol analysis) and 93.10%, 96.55% (by intention-to-treat analysis) respectively in phaseⅡ. There were no significant differences between the two groups (P>0.05). In the phase Ⅲ, the overall obvious response rates of the trial group and the control group were 90.54%, 73.08% (by per-protocol analysis) and 88.16%, 70.37% (by intention-to-treat analysis) respectively, and the overall response rates of the two groups were 94.59%, 96.15% (by per-protocol analysis) and 92.11%, 92.59% (by intention-to-treat analysis) respectively. There were no statistical differences between the two groups (P>0.05) too. No adverse effects were found in the trial. 

Conclusion: Chaige Qingre Granule is effective and safe in treating acute upper respiratory tract infection of wind heat syndrome.

Key words: herbal preparations, randomized controlled trials, doubleblinded method, respiratory tract infections, wind heat, traditional Chinese medicine

CLC Number: 

  • R562.2+1

Figure 1

Diagram of the randomized trial"

Table 1

Comparison of the baseline between two groups in phase Ⅱ (ITT)"

Items Trial Control t /χ2 P
Cases 29 229 21 21
Sex(M/F) ####### 5月24日 3.107 0.141
Mean age (x±s, year) 30.42±8.67 32.67±11.00 -0.863 0.392
Course (x±s, year) 1.28±0.45 1.43±0.50 -1.243 0.219
Severity (mild/moderate/severe) 10/19/0 13/16/0 0.649 0.592
Fever (none/mild/moderate/severe) 26/14/9/0 6/15/8/0 0.093 0.954
Tongue (normal/abnormal) 2月27日 5月24日 1.462 0.423
Pulse condition (normal/abnormal) 5月24日 9月20日 1.506 0.358

Table 2

Comparison of effect between two groups in phase Ⅱ [Cases (%)]"

Group n Cure Obvious effect Improvment Failur Z P
ITT 2 2 2 2 2 1 1
Trial 29 14 (48.28) 8 (27.59) 5 (17.24) 2 (6.70)
-0.54 -0.59
Control 29 16 (55.17) 7 (24.14) 5 (17.24) 1 (3.45) 1 1
PP 2 2 2 2 2 11 11
Trial 28 14 (50.00) 8 (28.57) 5 (17.86) 1 (3.57)
-0.57 0.569
Control 28 16 (57.14) 7 (25.00) 5 (17.86) 0 (0.00) 1 1

Table 3

Comparison of the baseline between two groups in phase Ⅲ (ITT)"

Items Trial Control t /χ2 P
Cases 76 227 21 21
Sex(M/F) 36/40 11月16日 3.107 0.141
Mean age (x±s, year) 35.24±15.15 39.22±17.35 1.128 0.262
Course (x±s, year) 1.22±0.45 1.07±0.27 1.628 0.107
Severity (mild/moderate/severe) 26/49/1 10/17/0 0 0.996
Body temperature (x±s, ℃) 37.81±0.88 37.86±0.42 -0.321 0.749
Tongue (normal/abnormal) 6/70 4月23日 1.088 0.297
Pulse condition (normal/abnormal) 31/45 11月16日 0 0.996

Table 4

Comparison of effect between two groups in [Cases (%)]"

Group n Cure Obvious effect Improvment Failur Z P
ITT 2 2 2 2 2 1 1
Trial 76 41 (53.95) 26 (34.21) 3 (3.95) 6 (7.89)
-1.276 0.202
Control 27 12 (44.44) 7 (25.93) 6 (22.22) 2 (7.41) 1 1
PP 2 2 2 2 2 11 11
Trial 74 41 (55.41) 26 (35.14) 3 (4.05) 4 (5.41)
-1.263 0.207
Control 26 12 (46.15) 7 (26.92) 6 (23.08) 1 (3.85) 1 1
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