Randomized Clinical Trial of Varun (Crataeva nurvala Buch.-Ham.)on Urinary Stent Encrustation
概览
- 阶段
- 3 期
- 状态
- 尚未招募
- 发起方
- Department of Shalya Tantra, Faculty of Ayurveda ,IMS BHU ,Varanasi
- 入组人数
- 40
- 试验地点
- 1
- 主要终点
- Assessment Criteria-
概览
简要总结
Urinary Stents and Catheters offer a Simple and effective drainage method for the Urinary tract. Long term use of Urinary Stents and Catheters are very frequents for therapeutic purpose of many urinary diseases and now considered a standard and indispensable urologic tool. Management of encrustation represents a continuum from therapeutic nuisance to major urologic intervention and finally it requires removal of stents and catheters and the purpose for which it was placed become defeated.
As per the literature of the Ayurvedic Text that a good number of drugs have been mentioned for the treatment of Ashmari (urolithiasis) . Varuna(Crataeva nurvala) is among them and are being practiced by the concerned physician as well as surgeon since long. This drug reduces metabolic diseases like stone disease and the encrustation as both stone and encrustation have same chemical constituents.
Currently there is no any clinical study available on ureteric stent encrustation however an experimental study shows positive response of effect of Varuna on ureteric stent encrustation. so there is need to research to see the clinical effect of varuna( Crataeva nurvala) on ureteric stent encrustation.
All the patients who will be studied under this clinical trial after completion of treatment for prescribed period will be instructed to have regular check up at the interval of 15 days for the period of 3 months (90days)
During this follow up study period patients will be examined thoroughly for the recurrence of either signs & symptoms of stones.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 盲法
- Participant Blinded
入排标准
- 年龄范围
- 15.00 Year(s) 至 70.00 Year(s)（—）
- 性别
- All
入选标准
- •1.Age- Between 15 to 70 years 2.Sex- Either Sex 3.Post operative renal/ureteric calculous patient with ureteric stent.
排除标准
- •1.Patients with Age below 15 years and above 70 years.
- •2.Malignancy 3.Patient undergoing treatment for any other serious illness.
- •4.HIV,HbsAg,Anti HCV-Positive.
结局指标
主要结局
Assessment Criteria-
时间窗: 2 months
After the urinary stent is removed, it undergoes a drying process in a 60°C oven for three hours to eliminate residual urine and prevent contamination. The stent is then segmented into four sections: renal pigtail, proximal straight part, distal straight part, and bladder pigtail, with a focus on the critical ureteral junctions known for encrustation development. Encrustation volume ratios (EVR) are calculated by normalizing encrustation volume to stent volume, eliminating bias from varying sample sizes. The total encrustation volume ratio (TEVR) sums EVRs across sections to assess overall susceptibility to encrustations. The encrustation risk level (ERL) is determined by dividing EVR by TEVR to identify sections most prone to encrustation, ensuring the removal of inter-sample variability.
时间窗: 2 months
次要结局
- To Study the Litholytic activity of Varun ghan vati on Urinary Stent Encrustation(2 months)
研究者
Dr Pankaj Kumar
BHU