Efficacy of Swarnamrithaprashana on promotion of immunity in children – a randomized double blind clinical trial
试验速览
- 阶段
- 2/3 期
- 状态
- 招募中
- 发起方
- 入组人数
- 200
- 试验地点
- 1
- 主要终点
- Changes in serum immunoglobulin G and salivary immunoglobulin A
研究概览
简要总结
This study is a Randomized Controlled DoubleBlind Two arm Prospective Clinical Trial comparing the efficacy ofSwarnamrithaprashana [containing Swarnabhasma, Honey, Ghee, Yastimadhu (Glycyrrhiaglabra Linn.) Guduchi (Tinospora cordifolia. Wild), Shankhapushpi (Convolvuluspluricaulis. Choisy), Vaca (Acoruscalamus Linn.), Jatamamsi (Nardostachys jatamansi DC.), Ashwagandha (Withaniasomnifera Dunal.), Pippali (Piper longum Linn.), Brahmi (Bacopa monnieri.Linn.)]/ Placebo (Sugar syrup) administered at a dose of one gelatinous capsule(0.4ml) daily for 30 days in 200 healthy children of 6 to 12 years agefulfilling the inclusion criteria. Efficacy of the trial drug and placebo willbe assessed on based on the changes in serum IgG and salivary IgA as primary outcomemeasures and changes in Atura bala and routine blood parameters as thesecondary outcome measures. BT and AT values will be taken on 0th day and 60thday of intervention respectively.
研究设计
- 研究类型
- Interventional
- 分配方式
- Random Number Table
- 盲法
- Participant and Investigator Blinded
入排标准
- 年龄范围
- 6.00 Year(s) 至 12.00 Year(s)（—）
- 性别
- All
入选标准
- •Healthy children of age group 6 to 12 years not under any sort of medication for last 30 days and whose parents are ready to sign the informed accent form and allow their children to participate in the clinical trial will be included.
排除标准
- •Children with any acute or chronic systemic disorders will not be considered for the trial.
结局指标
主要结局
Changes in serum immunoglobulin G and salivary immunoglobulin A
时间窗: 60 days
次要结局
- Changes in Aturabala (with specially designed format) and Blood routine (Hb%, TLC, DLC, ESR and RBC indices)(60 days)