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


CONCLUSIONS
Andrographolide drop-pill is effective and safe in the treatment of acute upper respiratory tract infection with external wind-heat syndrome.
Chang
Jing
J
Department of Integrated Traditional Chinese and Western Medicine, West China Hospital, Sichuan University, Chengdu, Sichuan Province 610041, China.
Zhang
Rui-ming
RM
Zhang
Ying
Y
Chen
Zhi-bin
ZB
Zhang
Zong-ming
ZM
Xu
Qiang
Q
Yang
Yu-ping
YP
Long
You-yu
YY
Liu
Liang-li
LL
Cai
Hong-yan
HY
Gao
Jie
J
Lu
Nan
N
Mao
Bing
B
Wang
Lei
L
Li
Ting-qian
TQ
D000328:Adult; D003937:Diagnosis, Differential; D004224:Diterpenes / Q000627:therapeutic use*; D005260:Female; D006801:Humans; D008297:Male; D008516:Medicine, Chinese Traditional; D008875:Middle Aged; D008517:Phytotherapy / Q000379:methods*; D012141:Respiratory Tract Infections / Q000188:drug therapy*; D013607:Tablets; D016896:Treatment Outcome
D004224:Diterpenes; D013607:Tablets; C030419:andrographolide