An open labelled controlled clinical study to evaluate the efficacy of kukkutanda basti in hypoalbuminemia in childhood minimal changes nephrotic syndrome.
试验速览
- 阶段
- 2/3 期
- 状态
- 尚未招募
- 发起方
- 入组人数
- 24
- 试验地点
- 1
- 主要终点
- To manage hypoalbuminemia through rectal route without overloading proteins
研究概览
简要总结
Introduction
Nephrotic syndrome is primarily a pediatric disorder and is 1.5 times more common in children than adults.
The incidence is 2-3/100,000 children per year and majority of affected children will have steroid-sensitive minimal change disease.
The characteristic features are heavy proteinurea >3-4+ /24 hr, hypoalbuminemia <2.5g/dl, edema and hyperlipidemia are often associated.
Etiology: - approximately 90% of children with nephrotic syndrome have idiopathic causes.
Divided into 2 groups in children 1) MCNS (High proteinuria) and 2) Nephrotic syndrome with significance lesions (low proteinuria)
MCNS protein urea pathophysiology: - Undefined mechanisms alter the permeability of the glomerular filter, resulting in massive proteinuria. Primary abnormality of the epithelial foot process (podocytes)
A loss of negatively charge glycoproteins within the glomerular capillary wall.
MCNS Oedema Pathophysiology Resultant fall in plasma oncotic pressure leads to interstitial edema and hypovolemia, stimulates the renin-angiotensin aldosterone axis and antidiuretics hormone secretion enhances Na and H2O retention.
Investigation shows 3-4+ g/dl proteinuria ,Serum albumin low below 2.5g/dl, serum cholesterol and triglycerides level are elevated
Blood urea and creatinine within normal level except when hypovolemia and fall in renal perfusion.
AIMS: - Tostudy the efficacy of the kukkutanda basti in hypoalbuminemia of childhood minimalchanges nephrotic syndrome.
OBJECTIVE: -Preventionof complications due to hypoalbuminemia.To study the role of Kukkutanda Bastiin arresting or prevent the complication during the progression of childhoodNS.
:Preventionof complications due to hypoalbuminemia.To study the role of Kukkutanda Bastiin arresting or prevent the complication during the progression of childhoodNS.
研究设计
- 研究类型
- Interventional
- 分配方式
- Computer generated randomization
- 盲法
- Not Applicable
入排标准
- 年龄范围
- 3.00 Year(s) 至 10.00 Year(s)（—）
- 性别
- All
入选标准
- •Age group- 3 to 10 years Diagnosed cases of primary type of nephrotic syndrome (idiopathic) of either the gender.
- •The other alternate modern treatment to be continued as per recommended dose according to allopathy treatment protocol as per the guideline Children with parents who agree to participate and sign informed consent.
排除标准
- •Patients of nephrotic syndrome due to other disorders i.e SLE, drug toxicity, any genetic disorders.
- •Patients of nephrotic syndrome associated with illness like cardiovascular disease, tuberculosis, immuno deficiency syndrome, etc.
- •Advanced or critical phase of nephrotic syndrome which requires immediate intervention like dialysis depending on history and general condition at the point of examination as found by the investigator will be excluded from the study.
结局指标
主要结局
To manage hypoalbuminemia through rectal route without overloading proteins
时间窗: 14 DAYS
次要结局
- Relief in post hypoalbuminemia symptoms i.e(1.Secondary oedema)