PDF(Pubmed)
Abstract：
BACKGROUND: Allergic rhinitis is largely treated by using antihistamines and nasal sprays, either alone or in combination. However, these measures ease out the symptoms but do not address causative factors, and have their share of side effects and limitations. An Ayurvedic herbo-mineral formulation, IMMBO, has been reported to be effective in treating allergic rhinitis.
OBJECTIVE: The present study was carried out to evaluate the efficacy, safety, and tolerability of the Ayurvedic herbo-mineral formulation in comparison with a fixed-dose combination of levocetirizine and montelukast.
METHODS: This was a randomized, comparative, clinical study carried out on 250 patients at a medical college in India. The patients were enrolled according to the eligibility criteria of the study and randomized into two groups, to receive either Ayurvedic herbo-mineral formulation, IMMBO, or a combination of levocetirizine and montelukast for 28 days. Total nasal symptom score (TNSS) and Immunoglobulin E (IgE) were calculated for evaluation of efficacy parameters. Result: At the end of therapy both IMMBO and levocetirizine and montelukast combination showed significant improvement in TNSS in both treated population and per protocol population. The IMMBO group had a statistically higher reduction in TNSSs compared to the levocetirizine + montelukast group (-5.70 vs. -3.31; p<0.01). There was a statistically significant difference in the reduction of IgE levels between the groups (-351.54 vs. -208.79; p<0.05). Conclusion: The findings of this study establish prima facie evidence about the efficacy and safety of Ayurvedic formulation. However, the said Ayurvedic formulation needs to be further developed scientifically.
OBJECTIVE: The present study was carried out to evaluate the efficacy, safety, and tolerability of the Ayurvedic herbo-mineral formulation in comparison with a fixed-dose combination of levocetirizine and montelukast.
METHODS: This was a randomized, comparative, clinical study carried out on 250 patients at a medical college in India. The patients were enrolled according to the eligibility criteria of the study and randomized into two groups, to receive either Ayurvedic herbo-mineral formulation, IMMBO, or a combination of levocetirizine and montelukast for 28 days. Total nasal symptom score (TNSS) and Immunoglobulin E (IgE) were calculated for evaluation of efficacy parameters. Result: At the end of therapy both IMMBO and levocetirizine and montelukast combination showed significant improvement in TNSS in both treated population and per protocol population. The IMMBO group had a statistically higher reduction in TNSSs compared to the levocetirizine + montelukast group (-5.70 vs. -3.31; p<0.01). There was a statistically significant difference in the reduction of IgE levels between the groups (-351.54 vs. -208.79; p<0.05). Conclusion: The findings of this study establish prima facie evidence about the efficacy and safety of Ayurvedic formulation. However, the said Ayurvedic formulation needs to be further developed scientifically.
摘要：
背景：过敏性鼻炎主要通过使用抗组胺药和鼻腔喷雾剂来治疗，单独或组合。然而,这些措施缓解了症状，但没有解决致病因素，并有副作用和局限性。阿育吠陀草药矿物配方，IMMBO,据报道可有效治疗过敏性鼻炎。
目的：本研究旨在评估疗效，安全,与左西替利嗪和孟鲁司特的固定剂量组合相比，阿育吠陀草药矿物制剂的耐受性和耐受性。
方法：这是一个随机的，比较,在印度一所医学院对250名患者进行的临床研究。根据研究的资格标准招募患者，并随机分为两组，接受阿育吠陀草药矿物配方，IMMBO,或左西替利嗪和孟鲁司特的组合28天。计算总鼻症状评分（TNSS）和免疫球蛋白E（IgE）以评估疗效参数。结果：在治疗结束时，IMMBO和左西替利嗪和孟鲁司特的组合在治疗人群和每个方案人群中均显示出TNSS的显着改善。与左西替利嗪+孟鲁司特组相比，IMMBO组的TNSSs在统计学上减少更多（-5.70vs.-3.31；p<0.01）。两组之间的IgE水平降低存在统计学上的显着差异（-351.54vs.-208.79；p<0.05）。结论：这项研究的结果建立了关于阿育吠陀制剂的有效性和安全性的初步证据。然而,上述阿育吠陀配方需要进一步科学发展。
目的：本研究旨在评估疗效，安全,与左西替利嗪和孟鲁司特的固定剂量组合相比，阿育吠陀草药矿物制剂的耐受性和耐受性。
方法：这是一个随机的，比较,在印度一所医学院对250名患者进行的临床研究。根据研究的资格标准招募患者，并随机分为两组，接受阿育吠陀草药矿物配方，IMMBO,或左西替利嗪和孟鲁司特的组合28天。计算总鼻症状评分（TNSS）和免疫球蛋白E（IgE）以评估疗效参数。结果：在治疗结束时，IMMBO和左西替利嗪和孟鲁司特的组合在治疗人群和每个方案人群中均显示出TNSS的显着改善。与左西替利嗪+孟鲁司特组相比，IMMBO组的TNSSs在统计学上减少更多（-5.70vs.-3.31；p<0.01）。两组之间的IgE水平降低存在统计学上的显着差异（-351.54vs.-208.79；p<0.05）。结论：这项研究的结果建立了关于阿育吠陀制剂的有效性和安全性的初步证据。然而,上述阿育吠陀配方需要进一步科学发展。
