Department of Pharmacology and Clinical Pharmacology, King George Medical University, Lucknow, India.
Phytomedicine. 2010 Mar;17(3-4):178-85. doi: 10.1016/j.phymed.2009.12.001. Epub 2010 Jan 25.
A randomized, double blind placebo controlled clinical study was conducted to evaluate the efficacy of KalmCold, 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 (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 treated group all symptoms showed a decreasing trend. Within groups, mean scores of symptoms in both the groups decreased significantly (p < or = 0.05) from day 1 to day 3 and day 5 while from day 3 to day 5 all symptoms except expectoration in placebo group did not improve significantly whereas in KalmCold treated group all symptoms improved significantly (p < or = 0.05) except earache. Comparing mean between both groups, all symptoms at day 1 and day 3 were found to be the same while at day 5 all symptoms except earache in KalmCold treated group improved significantly (p < or = 0.05) than placebo group. Similarly, within groups, overall scores of all symptoms in both the groups decreased significantly (p < or = 0.05) from day 1 to day 3 and day 5 while from day 3 to day 5 placebo group did not improve significantly whereas KalmCold treated group showed significant improvement (p < or = 0.05). On between groups analysis, KalmCold group showed significant reduction (p < or = 0.05) in overall symptom scores as compared to placebo group. In both placebo and KalmCold treated groups, there were only a few minor adverse effects with no significant difference in occurrence (Z = 0.63; p > 0.05). The comparison of overall efficacy of KalmCold over placebo was found to be significant (p < or = 0.05) and it was 2.1 times (52.7%) higher than placebo. The findings of this study revealed that KalmCold was effective in reducing symptoms of upper respiratory tract infection.
一项随机、双盲、安慰剂对照的临床研究评估了穿心莲提取物 Kal mCold 治疗上呼吸道感染（URTI）患者的疗效。通过视觉模拟量表评估症状评分。评估了 9 种自我评估的症状，包括咳嗽、咳痰、流涕、头痛、发热、咽痛、耳痛、不适/疲劳和睡眠障碍，每个症状的评分范围为 0-10 分。共有 223 名男女患者被随机分为两组，分别接受 Kal mCold（200mg/天）或安慰剂治疗，采用双盲法。在两种治疗中，所有症状的平均评分均呈现出从第 1 天到第 3 天逐渐下降的趋势，但从第 3 天到第 5 天，安慰剂治疗组的大多数症状要么保持不变（咳嗽、头痛和耳痛），要么恶化（咽痛和睡眠障碍），而 Kal mCold 治疗组的所有症状均呈下降趋势。组内比较，两组的症状评分均从第 1 天到第 3 天和第 5 天显著降低（p<0.05），而从第 3 天到第 5 天，除了安慰剂组的咳痰外，其他症状均无明显改善，而在 Kal mCold 治疗组中，所有症状均显著改善（p<0.05），除了耳痛。两组间比较，第 1 天和第 3 天所有症状均相同，而第 5 天，除了 Kal mCold 治疗组的耳痛外，其他症状均明显改善（p<0.05）。同样，在组内比较，两组的所有症状总评分均从第 1 天到第 3 天和第 5 天显著降低（p<0.05），而从第 3 天到第 5 天，安慰剂组无明显改善，而 Kal mCold 治疗组则有显著改善（p<0.05）。两组间分析，Kal mCold 组的总症状评分较安慰剂组有显著降低（p<0.05）。在安慰剂和 Kal mCold 治疗组中，仅有少数轻微不良反应，发生率无显著差异（Z=0.63;p>0.05）。Kal mCold 的总体疗效优于安慰剂（p<0.05），其疗效是安慰剂的 2.1 倍（52.7%）。这项研究的结果表明，Kal mCold 能有效减轻上呼吸道感染的症状。
