Cyavanaprāśa对健康儿童健康和免疫相关参数的评价:一项两组、随机、开放标记、前瞻性、多中心临床研究

Arun Gupta, Sunil Kumar, Sanjeeva Dole, Shailesh Deshpande, Vaishali Deshpande, Sudha Singh, V Sasibhushan
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引用次数: 17

摘要

背景:Cyavanaprāśa (CP)是一种阿育吠陀免疫增强剂配方,赋予活力和活力,同时延缓衰老过程。CP的益处已在成人人群中得到广泛研究。目的:本研究评估了CP对健康儿童健康和免疫相关参数的有益影响。方法:本研究是一项为期6个月的双臂、随机、开放标签、前瞻性临床研究。年龄在5-12岁之间的健康学龄儿童被随机分配,每天口服CP(约为。6克),然后是一杯牛奶(100 - 200毫升)或一杯牛奶,每天只喝两次,同时继续正常/常规饮食。根据研究期间儿童的发作次数、严重程度、疾病持续时间(感染和过敏)和因病缺勤天数,以及由其父母/法定代表人(LAR)记录在受试者日记中的精力、体能、力量、耐力和生活质量水平的变化,对结果进行分析。结果:702名参与者被随机化,其中627人完成了研究(CP n = 313;对照组n = 314)。免疫结果(感染或过敏相关疾病的发作)显示,与对照组相比,CP组对免疫相关疾病的保护超过2倍。通过KIDSCREEN QOL-27问卷评估,CP在儿童的能量水平、体能、力量、耐力和生活质量方面也显示出更好的百分比改善。结论:定期食用CP 6个月可显著提高学龄健康儿童的免疫力、能量水平、体质、力量、耐力和生活质量。研究注册:印度临床试验注册中心,编号CTRI/2015/02/005574,日期为2015年2月24日。
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Evaluation of Cyavanaprāśa on Health and Immunity related Parameters in Healthy Children: A Two Arm, Randomized, Open Labeled, Prospective, Multicenter, Clinical Study.

Context: Cyavanaprāśa (CP) is an Ayurvedic immune booster formulation that confers vigor and vitality while delaying the ageing process. Benefits of CP have been studied widely in adult population.

Objectives: Current study assessed beneficial effects of CP on health and immunity related parameters in healthy children.

Methods: This study was a 6 month long two armed, randomized, open labeled, prospective clinical study. School going healthy children between ages of 5-12 years were randomized to receive orally daily either CP (approx. 6 g) followed by a cup of milk (100 - 200 ml) or cup of milk only twice a day while continuing with their normal/routine diet. Results were analyzed based on number of episodes, severity, duration of illness (infections and allergies) and number of absent days due to illness during the study duration and changes in levels of energy, physical fitness, strength, stamina and quality of life in children which were recorded in subject diary by their parents/Legally Acceptable Representative (LAR).

Results: 702 participants were randomized, out of which 627 completed the study (CP n = 313; Control n = 314). Results of immunity (episodes of infections or allergy related conditions) showed more than 2 times protection from immunity related illness in CP Group as compared to the control. CP also showed better percentage improvement in energy levels, physical fitness, strength, stamina and quality of life assessed through KIDSCREEN QOL-27 questionnaires in children.

Conclusion: Regular consumption of CP for a period of six months could significantly improve immunity, energy levels, physical fitness, strength, stamina and quality of life in school going healthy children.

Study registration: Clinical Trail Registry of India vide CTRI/2015/02/005574, Dated 24 February 2015.

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