Swarna Prashana(口服黄金作为补剂)在婴儿中的免疫调节活性-一项随机对照临床试验。

Ayu Pub Date : 2019-10-01 Epub Date: 2021-01-14 DOI:10.4103/ayu.AYU_33_19
Jyothy Kothanath Bhaskaran, Kalpana Shantibhai Patel, Rajagopala Srikrishna
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引用次数: 4

摘要

背景:Swarna Prashana(口服黄金作为补液)是阿育吠陀经典中在儿科范围内描述的一种补液形式。如果黄金与Ghrita和蜂蜜一起服用28天,对婴儿免疫系统的特殊作用已得到强调。目的:本试验旨在评估Swarna Bhasma(煅烧粉末)、Madhu(蜂蜜)和Ghrita在婴儿中的人体测量学、血流变学和免疫学参数的安全性和有效性。方法:该试验是一项随机、对照、单盲研究,将102名健康婴儿分为试验组和对照组。试验组给予Swarna Bhasma、蜂蜜和Ghrita的混合物,对照组给予蜂蜜和Ghrita的混合物,均为滴剂,为期4周,随访8周。以生化指标评价安全性,以治疗前后IgG值评价疗效。结果:试验药物与对照药物的人体测量和生化指标差异无统计学意义,说明试验药物不影响婴儿的正常生长,可安全用于婴儿。试验药物和对照药物治疗前后IgG水平变化均有统计学意义;然而,当组间比较时,没有显著差异。然而,需要治疗的数量(NNT)来评估免疫球蛋白的正常化,这表明其免疫调节活性,每4535名接受Swarna Prashana的婴儿中有1名需要治疗,这是显著的。结论:Swarna Prashana不影响婴儿的正常生长。正如NNT所证明的那样,它显示出免疫调节活性,并且在试验或随访期间被婴儿耐受,没有不良反应。
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Immunomodulatory activity of Swarna Prashana (oral administration of gold as electuary) in infants - A randomized controlled clinical trial.

Background: Swarna Prashana (oral administration of gold as electuary) is a form of electuary depicted in the classics of Ayurveda under the ambit of pediatrics. A specific action on immune system has been highlighted in infants if gold is administered along with Ghrita and honey for a period of 28 days.

Aim: The present trial was conducted to assess the safety and efficacy of Swarna Bhasma (calcined powder), Madhu (honey) and Ghrita in infants with respect to anthropometrical, hematological and immunological parameters.

Methodology: The trial was a randomized, controlled, single-blind study in 102 healthy infants allocated into trial and control groups. Trial group received a mixture of Swarna Bhasma, honey and Ghrita, while control group received a mixture of honey and Ghrita, both in drops form for a period of 4 weeks with 8 weeks follow-up. Safety was assessed on the basis of biochemical parameters and efficacy was based on the values of IgG before and after the treatment.

Results: Anthropometrical and biochemical parameters did not showed any statistically significant difference between the effect of trial and control drugs, which suggested that the trial drugs did not hamper normal growth of the infants and were safe to be administered in infants. Both trial and control drugs showed statistically significant changes in IgG levels individually before and after the treatment; however, when compared between the groups, there was no significant differences. However, the number needed to treat (NNT) to assess the normalization of immunoglobulins, which is suggestive of its immunomodulatory activity, was 1 out of every 4.535 infants who received Swarna Prashana which was significant.

Conclusion: Swarna Prashana did not interfere with normal growth of the infants. As evident by NNT, it showed immunomodulatory activity and was tolerated by the infants with no adverse effects during the trial or follow-up period.

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