Efficacy of Gokshuradi tablet in Urolithiasis: A Randomized Controlled Trial
试验速览
- 阶段
- 3 期
- 状态
- 尚未招募
- 发起方
- 入组人数
- 48
- 试验地点
- 1
- 主要终点
- 1. Size of calculi in USG (2mm-10mm)
研究概览
简要总结
Urolithiasis is the formation of urinary calculi anywhere in the urinary tract. Urinary calculi are clinically characterized by colicky pain, known as renal colic, as they pass through the ureter, often accompanied by the presence of blood in the urine, known as hematuria. It can affect individuals of all ages, sexes, but it is more commonly observed in men than in women in a ratio 2:1. Conservative management of contemporary medical system includes, the dissolution of calculi often involves the administration of oral alkalinizing agents such as sodium or potassium bicarbonate, as well as potassium citrate, particularly for uric acid and cysteine calculi. Currently, surgical treatment options include extracorporeal shock wave lithotripsy (ESWL), percutaneous nephrolithotomy (PCNL), retrograde intrarenal surgery (RIRS) and laparoscopic ureterolithotomy. Open surgery procedures for kidney stones are also available. But these surgeries also has its complications like pain, perforation of the ureters, retained or forgotten ureteral stent, sepsis and also the cost of this surgeries are high. In ayurveda, urolithiasis can be correlated as Asmari. Gokshuradi tablet is selected for finding its action on reducing the size of renal calculi and other signs and symptoms. The constituents of the formulation are fruit of Tribulus terrestris Linn (Gokshura), whole plant of Dendrophthoe falcata (Linn.f.) Etting (Vrukshadani), rhizome of Berginia ligulata Wall (Pashanabheda), bark of Crataeva nurvala Buch-Ham. (Varuna), and aerial part of Hordeum vulgare Linn (Yavakshara). In Ayurveda people usually opt more easier form of drug administration. The medication in tablet form ensures a consistent dose, that is easy to consume. Gokshuradi tablet is a less scientifically observed formulation in Urolithiasis. Moreover, all the drugs in Gokshuradi tablet have proven its lithotryptic and diuretic action preclinically. Hence, the present study is indented to determine the efficacy of Gokshuradi tablet compared to Cystone tablet given twice daily in Urolithiasis as Randomized Controlled Trial.
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
- 20.00 Year(s) 至 65.00 Year(s)(—)
- 性别
- All
入选标准
- •1.Participants aged between 20-65 years diagnosed as Urolithiasis of irrespective of gender.
- •2.Calculi size in between 2mm-10mm by ultrasonography abdomen.
- •3.Participants who are willing to participate in the study.
排除标准
- •1.Participants with Chronic kidney disease, hydronephrosis(Grade 3 & 4), Gout, other Kidney disorders.
- •2.Known case of malignacy.
- •3.Pregnant and lactating women.
结局指标
主要结局
1. Size of calculi in USG (2mm-10mm)
时间窗: Baseline and 91st day
次要结局
- 1. Urine investigations - deposits,pus cells,RBC in urine(2.Blood test- Renal function test(Serum uria and serum creatine).)
研究者
Dr Aswathy G
Govt. Ayurveda College Thiruvananthapuram
