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临床试验/CTRI/2024/03/063952
CTRI/2024/03/063952尚未招募3 期

Tamsulosin alone and in combination with Deflazacort for medical expulsion therapy of distal ureteric calculus (less than 8mm): a randomized control study

Gautam Girish1 个研究点 分布在 1 个国家目标入组 132 人开始时间: 2024年3月18日最近更新:

试验速览

阶段
3 期
状态
尚未招募
发起方
入组人数
132
试验地点
1
主要终点
To assess stone expulsion rates on treatment with alpha blockers (Tamsulosin) and in combination with corticosteroids (Tamsulosin and Deflazacort) in patients diagnosed with distal ureteric calculus (less than 8mm)

研究概览

简要总结

Medical expulsion therapy (MET) is a non-surgical therapeutic option that is used for expulsion of calculus in uncomplicated symptomatic ureteral calculus cases . A variety of medications including alpha blockers, calcium channel blockers, phosphodiesterase inhibitors and corticosteroids have been tried to increase the expulsion rates and provide symptomatic relief to patients during the course of treatment. [1-4] But uncertainty still persist on the natural history of stone passage versus MET. Data and recommendations regarding use of alpha blockers are available, but insufficient data is available on use of corticosteroids to make a strong recommendation for its use.[5] Based on mechanism of action selective Alpha blockers act on Alpha1a receptors thereby causing dilatation of ureter and increased passage of ureteric calculus. Corticosteroids acts by reducing ureteral oedema, often seen at the time of ureteroscopy, thereby increasing the stone passage.   Overall lifetime prevalence of kidney stone disease varies from 1-15 % depending on race, sex, region and ethnicity with complications ranging from severe colicky pain to non-functional kidney requiring nephrectomy. Severity of pain affects the quality life of patients. Medical expulsion therapy helps in alleviating symptoms and avoiding active surgical intervention thereby reducing the cost, complications (surgical and anaesthesia related) and loss of work. MET also reduces the time of spontaneous stone passage and symptom. Through this study we aim to assess effect of alpha blockers alone and in combination with corticosteroid on stone expulsion rates in patients with distal ureteric calculus and to assess the effect of these medication on reduction in analgesics requirement.

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
18.00 Year(s) 至 90.00 Year(s)(—)
性别
All

入选标准

  • All patients who report to emergency/ Urology OPD with ureteric calculi 8 mm or less in size 2) Willing to consent for the study.

排除标准

  • Patient with urinary tract infection based on urine routine analysis and fever Uncontrolled pain Impaired kidney function Serum creatinine more than 1.4 mg/dl Solitary kidney.

结局指标

主要结局

To assess stone expulsion rates on treatment with alpha blockers (Tamsulosin) and in combination with corticosteroids (Tamsulosin and Deflazacort) in patients diagnosed with distal ureteric calculus (less than 8mm)

时间窗: Stone expulsion rate assessed at 2 weeks or when patient gives history of passage of stone whichever is earlier

次要结局

  • To assess stone expulsion rates on treatment with alpha blockers Tamsulosin alone and in combination with corticosteroids Tamsulosin and Deflazacort in patients diagnosed with ureteric calculus less than 8mm at 2 weeks(To assess stone expulsion based on size of stone less than 5mm and between 5 to 8 mm)

研究者

发起方
Gautam Girish
申办方类型
Other [self]
责任方
Principal Investigator
主要研究者

Gautam Girish

Kasturba medical college

研究点 (1)

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