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.