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临床试验/CTRI/2015/02/005488
CTRI/2015/02/005488尚未招募2/3 期

Clinical evaluation of Goksura churna and Sveta parpati in the Management of Mutrasmari (Urolithiasis)

Central Council for Research in Ayurvedic Sciences CCRAS1 个研究点 分布在 1 个国家目标入组 100 人开始时间: 2015年2月16日最近更新:

试验速览

阶段
2/3 期
状态
尚未招募
发起方
入组人数
100
试验地点
1
主要终点
Decrease in the size of calculus or expulsion of calculus

研究概览

简要总结

Mutrasmari (urolithiasis) is the condition where urinary calculi are formed or located anywhere in the urinary system, or the process of forming stones in the kidney, bladder, and/or ureters (urinary tract). Mutrasmari is a common cause of haematuria, abdominal pain, pain in flank, or groin. It occurs in one in 20 people at some time in their lives. The stones form in the urine-collecting area (the pelvis) of the kidney and may range in size from tiny to staghorn stones the size of the renal pelvis itself. In Ayurveda, asmari is described as one of Mahagada. In industrialized countries 10% of men and 3% of women have the problem of Mutrasmari. It occurs in people aged 35-45 years, but the disease can affect anyone at any age. xml:namespace prefix = o ns = "urn:schemas-microsoft-com:office:office" /

During recent decades, pharmacologic intervention has become more effective in stone disease: drugs can control the pain of renal colic, interfere at various levels in development of Mutrasmari, and contribute to the expulsion of stones. It is well known that development of Mutrasmari is a multifactorial process influenced by environmental-nutritional factors (low urinary volume, diet rich in animal protein, etc) and metabolic alterations; i.e., hypercalciuria, hyperuricosuria, and deficiency of stone-inhibiting factors (citrate, magnesium, glycosaminoglycans [GAGs]). Specific drugs such as citrate, allopurinol, and thiazide represent highly effective treatments for the promoting factors. Surgical approaches like extracorporeal shockwave lithotripsy (SWL) and endourologic techniques are also common practices, now-a-days in its treatment.

Ayurvedic medicines have been used since ancient times for the prevention and treatment of various diseases in human.  Treatment of Mutrasmari in Ayurveda is an established therapy and free from operational hazards. It is the best alternative to lithotripsy (expensive) and operation. The stone size which is less than 7mm Ayurvedic drugs are very effective due to the litholytic property. This is proved by several research works. In the present study, clinical evaluation of Goksura churna and Sveta parpati in the patients of Mutrasmari will be carried out. These Ayurvedic drugs are very cost-effective, low risk (associated with mortality and morbidity) and not required for admission in the hospital.

研究设计

研究类型
Interventional
分配方式
Not Applicable
盲法
Open Label

入排标准

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

入选标准

  • Age: Between 20-70 years
  • Sex: Either sex
  • Any three of the following signs and symptoms if present i.
  • Intermittant dull/colicky pain in back radiating from loin to groin, which increase on movements/ jerks ii.
  • Haematuria iii.
  • Frequency of micturition iv.Burning micturition
  • Evidence of calculus as per modern diagnostic procedures (Evidence of urolithiasis in any of the following) -CT abdomen non-contrast -U.S.G. KUB region -Stone size <7mm.

排除标准

  • 1.Age: Below 20 and above 70 years 2.Serum creatinine 1.5mg% 3.Stag horn renal stone 4.Hydronephrosis 5.Pyelonephritis 6.Diabetes mellitus 7.Malignancy 8.Chronic renal failure 9.Severe urinary tract infection or any other infection 10.Impaired renal function 11.Any other complications of calculus.

结局指标

主要结局

Decrease in the size of calculus or expulsion of calculus

时间窗: 3 months

次要结局

  • Changes in the clinical sign & symptoms of Mutrasmari (Urolithiasis)(3 years)

研究者

发起方
Central Council for Research in Ayurvedic Sciences CCRAS
申办方类型
Research institution

研究点 (1)

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