Clinical Evaluation of Immunomodulatory Effect of Swarnaprashan in Children: A Prospective Open Label Study
试验速览
- 阶段
- 2 期
- 状态
- 已完成
- 发起方
- 入组人数
- 30
- 试验地点
- 1
- 主要终点
- To Observe the Immunomodulatory effect of Swarnaprashan.
研究概览
简要总结
Childrenare vulnerable to infections because their immune system is less developed.This has long adverse effect on child’s physical and mental growth. The globalburden of child death is call for urgent and concerted action to furtherimprove the survival chances of the world’s children. A baby’s immune system isnot fully developed thus, more prone to infections than in adults. Thus ahealthy immune system is very important for the maintenance of health andprevention of diseases. In children the major causes of childhood morbidity andmortality are various preventable infections. Though National vaccinationschedule is implicated, mortality rate in India is still high. From the firstday of life vaccination schedule is started but these vaccine do not protectthe child from the disease by bacterial infection, viral infections andprimary, secondary immunodeficiency syndrome. If proper precautions are taken,many of these diseases can be prevented. The under five mortality rate for theworld is 40.8 death and Infant mortality rate in India is 36.6 death accordingto the world bank and the world health organization. 5.6 million children underfive age died in 2006, 15000 everyday.1,2,3
Theleading cause of death among children under age five included4-
Preterm birth complication 18%·
Intra-partum related events 13%·
Pneumonia 15%·
Diarrhea 8%·
Neonatal sepsis 7%·
Malaria 5%·
Malnutrition and under nutrition·
In 2017,an estimated 6.3 million children and adolescents died, mostly from preventablecause and 85% of the 6.3 million deaths in 2017 occurring in the first fiveyears of life5.
Parentsreported symptoms suggestive of a history of Eczema in 10.3%, Rhinitis in 24.2%and Asthma in 23.6% of children. Overall 43.7% of children had symptomssuggestive of at least on allergic disorder, with a substantial minority manifestingsymptoms indicative of co-morbid allergic disorder. 6
Ayurveda,presents different concept of immunity( vyadhikshmatva) which is internalstrength or bala, that comes from the doshas being in balance, digestion andmetabolism functioning normally and the tissues growing properly.Vyadhikshmatva is the inherent or an acquired
2
capacityof the body in preventing a disease or in modifying the course on an alreadymanifested disease to a milder extent.
KashyapSamhita is an oldest text book of Kaumarbhritya written by Vridhajeevaka.Kaumarbhritya is one of leading branch of Ayurveda that dealing with mother andchild health care. Kashyapa has described the concept of Lehan in which thepractice of administration of processed gold is mentioned as Swarnaprashan.
Acharyahave mentioned many benefits of Swarnaprashan-
• Medhavardhan- Intellect promoting
• Agnivardhan- Improvement in digestion
• Balavardhan- Strength promoting
•Ayushyam- Improvement in life expectancy
• Mangal,Punya- Auspicious
• Vrishya-Aphrodisiac
•Varnaya- Improvement in complexion and skin texture
•Grahapaham- Protection from evil spirits and microorganisms
•Shrutdhara- Capable of grasping even on listening
Most ofthe classics mentioned different Lehanas for the children mainly they are thecombination of Swarna, Ghrita and Madhu. Charak Samhita mentioned only mixtureof Ghrita and Madhu.
研究设计
- 研究类型
- Interventional
- 分配方式
- Not Applicable
- 盲法
- Open Label
入排标准
- 年龄范围
- 2.00 Year(s) 至 5.00 Year(s)（—）
- 性别
- All
入选标准
- •Children aged from 2-5 years of either sex
- •Childern with recurrent respiratory infections
- •Childern with recurrent G.I.T. diseases
- •Children with recurrent fever
- •Children with recuurent episodes of diarrhea 6.
排除标准
- •Subjects suffering from major systemic illness necessitating long term treatment
- •Subjects with evidence of malignancy
- •Subject with aspartate amino transferase(AST) and or alanine amino transferase ALT>3 Times of the upper normal limit and renal dysfunction (Sr. creatinine >1.2mg/dl), uncontrolled pulmonary dysfunction( asthmatic and COPD patients) .
- •Co-morbidity like TB, UTI and bleeding disorders etc
- •Congenital anomalies and hereditary disease.
- •Pulmonary or abdominal tuberculosis.
- •H/O hypersensitivity to any of the trial drug or any of its ingredients.
- •Subjects who have completed participation in any other clinical trial during the past six months.
- •Any contraindications mentioned for Lehan karma in Kashyap Samhita.
结局指标
主要结局
To Observe the Immunomodulatory effect of Swarnaprashan.
时间窗: 8 weeks
次要结局
- Reduction in Morbidity rate in children.(8 weeks)