Bhaskaran Jyothy Kothanath, Patel Kalpana Shantibhai, Srikrishna Rajagopala
Department of Kaumarabhritya, Mahatma Gandhi Ayurved Medical College, Hospital and Research Centre, Constituent College of Datta Meghe Institute of Medical Sciences Deemed to be University, Wardha, Maharashtra, India.
Department of Kaumarabhritya, ITRA, Jamnagar, Gujarat, India.
Ayu. 2019 Oct-Dec;40(4):230-236. doi: 10.4103/ayu.AYU_33_19. Epub 2021 Jan 14.
(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 and honey for a period of 28 days.
The present trial was conducted to assess the safety and efficacy of (calcined powder), (honey) and in infants with respect to anthropometrical, hematological and immunological parameters.
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 , honey and , while control group received a mixture of honey and , 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.
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 which was significant.
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.
（口服金剂作为糖膏剂）是阿育吠陀经典中描述的一种儿科范围内的糖膏剂形式。如果在28天内将金剂与[具体物质]和蜂蜜一起给婴儿服用，已强调其对免疫系统有特定作用。
本试验旨在评估[煅烧粉末]、[蜂蜜]和[具体物质]在婴儿的人体测量学、血液学和免疫学参数方面的安全性和有效性。
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。试验组接受[煅烧粉末]、蜂蜜和[具体物质]的混合物，而对照组接受蜂蜜和[具体物质]的混合物，均为滴剂形式，为期4周，并进行8周的随访。根据生化参数评估安全性，有效性基于治疗前后IgG的值。
试验药物和对照药物的效果在人体测量学和生化参数方面未显示出任何统计学上的显著差异，这表明试验药物不会妨碍婴儿的正常生长，并且对婴儿给药是安全的。试验药物和对照药物在治疗前后各自的IgG水平均显示出统计学上的显著变化；然而，在组间比较时，没有显著差异。但是，评估免疫球蛋白正常化所需的治疗人数（NNT）表明其具有免疫调节活性，每4.535名接受[煅烧粉末]的婴儿中有1名显著。
[煅烧粉末]不干扰婴儿的正常生长。从NNT可以明显看出，它具有免疫调节活性，并且在试验或随访期间婴儿能够耐受，没有不良反应。
