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临床试验/NCT06753526
NCT06753526已完成4 期

L-Arginine Role for Stone Lower Ureter : A Randomized Control Study

Sohag University1 个研究点 分布在 1 个国家目标入组 153 人开始时间: 2023年7月1日最近更新:
适应症
干预措施
相关药物

试验速览

阶段
4 期
状态
已完成
入组人数
153
试验地点
1
主要终点
Spontaneous stone expulsion rates (SER)

研究概览

简要总结

To evaluate the effects of L-Arginine 1000mg once daily as a medical expulsive therapy (MET) for lower ureter stones.

详细描述

Urolithiasis is a common disease worldwide and its incidence is growing [1]. Urinary stones are frequently located in the ureter and most ureteral stones are reported to be located distally [2]. Stones < 3 mm in diameter have a better chance to pass spontaneously in the majority of cases, whereas stones > 6 mm in the ureter are unlikely to pass in most situations [3].

Therefore, active watchful waiting forms one of the treatment options in some clinical scenarios.

Minimal invasive treatment strategies such as extracorporeal shockwave lithotripsy and ureteroscopy are frequently applied procedures in ureteral stone disease. However, indications for watchful waiting might be extended by the addition of so-called 'expulsive medical therapy'.

Nitric Oxide (NO) L -Arginine-derived NO is the major inhibitory NANC neurotransmitter in the lower urinary tract [4]. Neuronal NO synthase (NOS)-positive neuronal axons and nerve-ending-like structures have been detected in muscular layers of the human ureter suggesting that ureteral relaxation may involve the NO pathway [5]. NOS-reactive nerves have also been demonstrated immunohistochemically in the human intravesical ureter.

A recent study suggested that the L-arginine/NO/cyclic GMP pathway may play a role in the regulation of the valve function of the ureterovesical junction [6].

研究设计

研究类型
Interventional
分配方式
Randomized
干预模型
Parallel
主要目的
Treatment
盲法
None

入排标准

年龄范围
18 Years 至 —(Adult, Older Adult)
性别
All
接受健康志愿者

入选标准

  • 未提供

排除标准

  • 未提供

研究组 & 干预措施

Group I

Placebo Comparator

about 53 patient, received NSAIDs

干预措施: NSAID (Drug)

Group II

Active Comparator

about 53 patients received L-arginine 1000 mg once daily

干预措施: L-Arginine, 500 Mg Oral Capsule (Drug)

group III

Active Comparator

included 51 patients who received Tamsulosin 0.4 mg once daily.

干预措施: Tamsulosin 0.4 mg QD (Drug)

结局指标

主要结局

Spontaneous stone expulsion rates (SER)

时间窗: From 1st renal colic till the time of stone pass or for four weeks

detect the rate at which stone pass from the ureter

Stone expulsion time

时间窗: From 1st renal colic till the time of stone pass or for four weeks

time at which stone pass

Number of daily colic episodes

时间窗: number of colicky attack From 1st renal colic till the time of stone pass or for four weeks

number of renal colic attack

Total required analgesic dosage

时间窗: From 1st renal colic till the time of stone pass or for four weeks

Total required analgesic dosage

次要结局

未报告次要终点

研究者

申办方类型
Other
责任方
Principal Investigator
主要研究者

Ahmed Mahmoud Mohammed Ahmed Elsherief

lecturer of urology at faculty of medicine ,sohag university

Sohag University

研究点 (1)

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