A RANDOMIZED CONTROLLED CLINICAL TRIAL ON SWARNA PRASHANA (GOLD PREPARATION) IN INFANTS W.S.R. TO ITS IMMUNOMODULATORY ACTIVITY

DIRECTOR1 个研究点分布在 1 个国家目标入组 100 人开始时间: 2012年3月14日最近更新: 2020年10月10日

试验速览

阶段: 2/3 期
状态: 已完成
发起方
入组人数: 100
试验地点: 1
主要终点: 1. Changes in Immunological Profile

研究概览研究设计入排标准结局指标研究者研究点记录与标识符相似试验

研究概览

简要总结

This study is a Randomized, Single blind, Parallel group, Active controlled Clinical Trial on Swarna Prashana(Gold Preparation) in infants with special reference to its immunomodulatory activity. The Primary outcome measures are changes in Immunological profile and pattern of growth and development along with anthropometric changes at baseline and after 4 weeks of intervention.

研究设计

研究类型: Interventional
分配方式: Computer generated randomization
盲法: Participant Blinded

入排标准

年龄范围: 0.00 Day(s) 至 12.00 Month(s)（—）
性别: All

入选标准

•1.Healthy full term infants aging from 0 Day-12 Months of either sex, irrespective of caste and socio- economic status 2.Birth weight >2.5kg.

排除标准

•1.Infants more than 12 months 2.Premature and Post mature babies 3.Infants with congenital abnormalities and those requiring emergency care 4.Infants with any systemic diseases which may turn out to be hindrance during the course of the study.

结局指标

主要结局

1. Changes in Immunological Profile

时间窗: At Baseline and after 4 weeks of trial

2. Pattern of growth and development with Anthropometric changes

时间窗: At Baseline and after 4 weeks of trial

次要结局

Pattern of growth and development with Anthropometric changes

研究者

发起方

DIRECTOR

申办方类型

Research institution

研究点 (1)

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