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Journal of Chinese Integrative Medicine ›› 2008, Vol. 6 ›› Issue (12): 1238-1245.doi: 10.3736/jcim20081206

• Original Clinical Research • Previous Articles     Next Articles

Andrographolide drop-pill in treatment of acute upper respiratory tract infection with external wind-heat syndrome: a multicenter and randomized controlled trial

Jing Chang1, Rui-ming Zhang1(), Ying Zhang1, Zhi-bin Chen2, Zong-ming Zhang3, Qiang Xu4, Yu-ping Yang5, You-yu Long6, Liang-li Liu7, Hong-yan Cai8, Jie Cai9, Nan Lu10, Bing Mao1, Lei Wang1, Ting-qian Li1   

  1. 1. Department of Integrated Traditional Chinese and Western Medicine, West China Hospital, Sichuan University, Chengdu, Sichuan Province 610041, China
    2. Department of Respiratory Diseases, Fujian Academy of Traditional Chinese Medicine, Fuzhou,Fujian Province 350108, China
    3. Department of Respiratory Diseases, the First Affiliated Hospital, Anhui College of Traditional Chinese Medicine, Hefei, Anhui Province 230031, China
    4. Department of Respiratory Diseases, Affiliated Hospital, Anhui Medical University, Hefei, Anhui Province 230022, China
    5. Department of Respiratory Diseases, Affiliated Hospital, Jiangxi College of Traditional Chinese Medicine, Nanchang, Jiangxi Province 330006, China
    6. Department of Respiratory Diseases, the Second Affiliated Hospital, Tianjin College of Traditional Chinese Medicine, Tianjin 300150, China
    7. Department of Respiratory Diseases, the First Affiliated Hospital, Guiyang College of Traditional Chinese Medicine, Guiyang,Guizhou Province 550001,China
    8. Department of Respiratory Diseases, Jilin Academy of Traditional Chinese Medicine, Changchun, Jilin Province 130021, China
    9. Department of Respiratory Diseases, Affiliated Hospital, Shaanxi College of Traditional Chinese Medicine, Xi'an, Shaanxi Province 712083,China
    10. Department of Respiratory Diseases, General Hospital of Beijing Military Region, Beijing 100700, China
  • Received:2008-07-21 Online:2008-12-20 Published:2008-12-15

Objective: 

To evaluate the safety and efficacy of andrographolide drop-pill in treatment of acute upper respiratory tract infection with external wind-heat syndrome.


Methods:

A multicenter, randomized controlled trial was conducted. In phase Ⅰ, 202 patients with acute upper respiratory tract infection were randomly divided into two groups: trial group (n=101) and control group (n=101). In phase Ⅱ, 276 patients with acute upper respiratory tract infection were randomly divided into two groups: trial group (n=138) and control group (n=138). The patients in the trial group received andrographolide drop-pill, at a dose of 1.5 g, three times a day; the patients in the control group received andrographolide tablet, at a dose of 1.5 g, three times a day. The therapeutic courses in both groups were 3 days. Clinical symptoms, physical signs, adverse effects, blood, urine and stool tests, hepatorenal function and electrocardiogram were examined before and after the treatment.


Results:

After treatment in the phaseⅠ, the cure rates in the trial group and the control group were 44.55%, 42.57% (full analysis set, FAS) and 45.00%, 43.00% (per protocol set, PPS), and the total obvious rates were 94.06%, 94.06% (FAS) and 95.00%, 95.00% (PPS), respectively. There were no significant differences between the two groups (P>0.05). In the phase Ⅱ, the cure rates in the trial group and the control group were 39.13%, 33.82% (FAS) and 38.69%, 33.58% (PPS), and the total obvious rates were 96.38%, 96.32% (FAS) and 96.36%, 96.27% (PPS), respectively. There were no significant differences between the two groups (P>0.05) too. No adverse effects were found in the trial.


Conclusion:

Andrographolide drop-pill is effective and safe in the treatment of acute upper respiratory tract infection with external wind-heat syndrome.

Key words: plant preparations, randomized controlled trial, respiratory tract infections, wind-heat, traditional Chinese medicine

CLC Number: 

  • R511.6

Figure 1

Diagram of the randomized trial"

Table 1

General data of the two groups in phase Ⅰ"

Item Trial group Control group χ2/t P
Case 100 100
Sex (male/female) 57/43 62/38 0.519 0.471
Average age (year) 36.31±11.63 37.55±12.69 0.546 0.586
Duration (h) 22.44±12.22 20.70±8.46 1.311 0.191
Body temperature (℃) 38.08±0.81 38.06±0.58 0.221 0.825
Accumulated score of TCM symptoms 19.68±5.56 19.61±6.42 0.082 0.934
Tongue condition (abnormal/normal) 85/15 88/12 0.385 0.535
Pulse condition (abnormal/normal) 86/14 83/17 0.346 0.558

Table 2

Efficacy outcome of the two groups in phase Ⅰ"

Data set Group n Cure[Cases (%)] Obvious effect
[Cases (%)]
Improvement
[Cases (%)]
No improvement
[Cases (%)]
CMHχ2 P
FAS Trial 101 45 (44.55) 38 (37.62) 12 (11.88) 6 (5.94) 0.000 0.983
Control 101 43 (42.57) 43 (42.57) 9 (8.91) 6 (5.94)
PPS Trial 100 45 (45.00) 38 (38.00) 12 (12.00) 5 (5.00) 0.000 0.983
Control 100 43 (43.00) 43 (43.00) 9 (9.00) 5 (5.00)

Table 3

General data of the two groups in phase Ⅱ"

Item Trial Control χ2/Z P
Case 138 136
Sex (male/female) 67/71 62/74 0.241 0.623
Average age (year) 37.18±13.64 36.09±14.43 0.644 0.520
Duration (h) 20.46±9.93 21.05±10.83 –0.474 0.636
Body temperature (℃) 37.78±0.33 37.79±0.33 –0.377 0.707
Accumulated score of TCM symptoms 15.91±3.94 16.03±4.11 –0.254 0.800
Tongue condition (abnormal/normal) 85/53 88/48 0.285 0.593
Pulse condition (abnormal/normal) 84/54 79/57 0.270 0.874

Table 4

Efficacy outcome of the two groups in phase Ⅱ"

Data set Group n Cure
[Cases (%)]
Obvious effect
[Cases (%)]
Improvement
[Cases (%)]
No improvement
[Cases (%)]
CMHχ2 P
FAS Trial 138 54 (39.13) 56 (40.58) 22 (15.94) 6 (4.35) 2.634 0.105
Control 136 46 (33.82) 55 (40.44) 28 (20.59) 7 (5.15)
PPS Trial 137 53 (38.69) 56 (40.88) 22 (16.06) 6 (4.38) 2.864 0.091
Control 134 45 (33.58) 54 (40.30) 28 (20.90) 7 (5.22)
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