A randomized double blind placebo controlled clinical evaluation of extract of Andrographis paniculata (KalmColdâ„¢) in patients with uncomplicated upper respiratory tract infection

A randomized double blind placebo controlled clinical evaluation of extract of Andrographis paniculata (KalmColdâ„¢) in patients with uncomplicated upper respiratory tract infection
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DOI:
10.1016/j.phymed.2009.12.001
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发表时间:
2010-03-01
期刊:
影响因子:
7.9
通讯作者:
Amit, A.
Amit, A.
中科院分区:
医学1区
文献类型:
--
作者:
Saxena, R. C.;Singh, R.;Amit, A.

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采用随机、双盲、安慰剂对照的临床研究方法,评价穿心莲提取物Kalmice(TM)治疗单纯性上呼吸道感染(URTI)的疗效。评估包括用视觉模拟量表对症状评分进行量化。对咳嗽、咳痰、流鼻涕、头痛、发热、咽喉痛、耳痛、不适/疲劳、睡眠障碍等9项自评症状进行评分。共有223名男女患者被随机分成两组,一组每天服用200毫克Kalmice(TM),另一组服用安慰剂,采用双盲方式。在两种治疗方法中,从第1天到第3天,所有症状的平均分都呈下降趋势,但从第3天到第5天,安慰剂组的大多数症状要么保持不变(咳嗽、头痛和耳痛),要么加重(喉咙痛和睡眠障碍),而在Kalmice(TM)治疗组,所有症状都有减少的趋势。在组内,两组的平均症状评分均显著降低(p
A randomized, double blind placebo controlled clinical study was conducted to evaluate the efficacy of KalmCold(TM), an extract of Andrographis paniculata, in patients with uncomplicated upper respiratory tract infection (URTI). The assessment involved quantification of symptom scores by Visual Analogue Scale. Nine self evaluated symptoms of cough, expectoration, nasal discharge, headache, fever, sore throat, earache, malaise/fatigue and sleep disturbance were scored. A total of 223 patients of both sexes were randomized in two groups which received either KalmCold(TM) (200 mg/day) or placebo in a double blind manner. In both the treatments, mean scores of all symptoms showed a decreasing trend from day 1 to day 3 but from day 3 to day 5 most of the symptoms in placebo treated group either remained unchanged (cough, headache and earache) or got aggravated (sore throat and sleep disturbance) whereas in KalmCold(TM) treated group all symptoms showed a decreasing trend. Within groups, mean scores of symptoms in both the groups decreased significantly (p