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临床试验/CTRI/2023/05/053091
CTRI/2023/05/053091尚未招募3 期

An open labelled randomised comparative clinical and invitro study to evaluate the effect of Pashanabhedadi kashaya ghana capsule and Pashanabheda kashaya ghana capsule in the management of Mootrashmari vis-Ã -vis Nephrolithiasis

未提供1 个研究点 分布在 1 个国家目标入组 100 人开始时间: 2023年1月6日最近更新:

试验速览

阶段
3 期
状态
尚未招募
入组人数
100
试验地点
1
主要终点
EXPULTION OF KIDNEY STONES

研究概览

简要总结

Background of the study:

Nephrolithiasis or calculi formation in kidneys, is a common problem worldwide,  with prevalence of 7% in the adults and > 30% recurrence  rate within 10years. The incidence  of Nephrolithiasis is globally increasing with an estimated prevalence ranging up to 15%. During lifetime, approximately 7% of women and 13% of men will develop a kidney stone. In Indian population, about 12% of them are expected to have urinary stones and  out of which 50% may end up loss of kidney functions. Invasive therapies for removal of calculi such as ESWL ( Extra corporeal shock wave  Lithotripsy). PCNL (Percutaneous nephrolithotripsy), Basketing therapy, Pylolithotomy are commonly for the management of Nephrolithiasis . Features of Nephrolithiasis are closely similar to the disease Mootrashmari in the Ayurveda parlance and majority of the pathology in both the condition are similar.

Purpose of the study:

In spite of technological advances in the field of  medicine and surgery conservative therapy still continues to a solution for all reversible ailments. Even though invasive therapies are one of the  alternatives used commonly for the management of Nephrolithiasis , however these therapies  have their  own disadvantages and complications. Kshara, kashaya  and churna  yogas  are frequently used  forms of medicines, palatability is major challenges. Considering the magnitude of the condition at present, there is a need of widely acceptable, evidence based, cost effective, easily available, simple, safe and single drug for Nephrolithiasis.

研究设计

研究类型
Interventional
分配方式
Random Number Table
盲法
Not Applicable

入排标准

年龄范围
18.00 Year(s) 至 70.00 Year(s)(—)
性别
All

入选标准

  • Diagnosed cases of Mootrashmari vis-Ã -vis Nephrolithiasis as per the diagnostic criteria Patients with solitary or multiple renal calculi with size less than or equal to 10 mile meter size Participants are willing to provide informed consent.

排除标准

  • Patients with associated obstructive pathologies like BPH urethral stricture and congenital anatomical abnormalities Renal calculi in associated with uretreric bladder or uretral calculi During the phase of Renal colic and Ureteric colic Patients with severe Hydronephrosis Pregnant women and lactating mothers Systemic diseases which interfere with disease process and present clinical trial.

结局指标

主要结局

EXPULTION OF KIDNEY STONES

时间窗: AT 45TH DAY

次要结局

  • IMPROVEMENT OF QUALITY OF LIFE(based on a questionnaire)

研究者

发起方
未提供

研究点 (1)

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