跳至主要内容
临床试验/CTRI/2014/10/005154
CTRI/2014/10/005154已完成4 期

CLINICAL STUDY TO ASSESS THE THERAPEUTIC PROPERTIES OF AYURVEDIC FORMULATION OF HORDEUM VULGARE (Yava) IN THE MANAGEMENT OF RENAL CALCULI

Dr K V Chakradhar1 个研究点 分布在 1 个国家目标入组 100 人开始时间: 2014年1月12日最近更新:

试验速览

阶段
4 期
状态
已完成
发起方
入组人数
100
试验地点
1
主要终点
1.expulsion of the renal calculi

研究概览

简要总结

The incidence of renal calculi (urolithiasis) isincreasing in both developed and developing countries. It is estimated that 12%of world population experiences renal stone disease with a recurrence rate of70-80% in males and 47-60% in females.  Urolithiasis carries high risk of recurrenceafter the initial episode, of around 50% at 5 years and 70% at 9 years. Searchfor alternative medicines available at low cost which exhibit least adverseeffects are anticipated to benefit many poor patients with renal calculi. Ithas been described in Ayurveda that Hordeum vulgare is effective in theexpulsion of renal calculi. SuÅ›ruta the father of surgery explained urinary calculusunder the heading of Ashmari in details including etiological factors,classification, symptomatology, pathology, complications and its management ina most scientific manner. This disease is dreadful and hence considered one ofthe ‘MahÄgadÄs’ by SuÅ›ruta, may beowing to its potentiality to disturb the anatomy and physiology of urinarysystem. The old bladder stone is reported at “ELAMARAH†in Upper Egypt, datedabout 4800 BC, shows that humans of ancient time were undoubtedly affected withthe disease Ashmari just as humans are now. Å–igveda and Atharavaveda (2000 –5000 BC) also mentioned the stone and advise people not to ride a horse, Carakahas advised medical management and SuÅ›ruta advised both conservative andsurgical removal of stone through perineal root cystolithotomy.All the Acharyas except Charaka have classified the disease MÅ«trÄÅ›mari intofour types.

i.e. i.) Shleshmaja Ashmari

ii.) Pittaja Ashmari

iii.) Vataja Ashmari

iv) ShukrajaAshmari

Management of various types of Ashmari has been described in SuÅ›ruta SamhitÄ in view of the fatalityof the diseases treatment has been advised to be undertaken in the early stagesof the disease. GhÅ—ta recipes forthree types of calculi have been mentioned along with indication of appropriatefood, drinks and other measures, where he exclusively described about the usageof Yava Kshara.Indication for the surgical management has been givenalong with a note of caution regarding its dangers and doubtful chances ofsuccess. It was to be undertaken only on failure of conservative treatment andwhen death was inevitable if not treated surgically**.** However,there is no comprehensive analysis and the formulation has not beenscientifically validated. Ours is the first attempt to validate the formulationdescribed in Ayurveda. Development of new formulations which are likely to becheaper and exhibit minimal or no adverse effects will be beneficial. Thepreliminary results advocate undertaking systematic scientific studies of the Hordeumvulgare formulation in the management of renal calculi. In view of the abovefacts and also the existing clinical trial data, it is proposed to validate theformulation through systematic studies.

研究设计

研究类型
Interventional
分配方式
Coin toss, Lottery, toss of dice, shuffling cards etc
盲法
Participant Blinded

入排标准

年龄范围
16.00 Year(s) 至 60.00 Year(s)(—)
性别
All

入选标准

  • •Sex: Either sex •Radiological evidence of stone (>5 mm to <10 mm) in Kidney, Ureter and Urinary Bladder.

排除标准

  • •Stone size more than 10 mm.
  • •Impacted stone.
  • •Gross Hydronephrosis.
  • •Pyelonephritis.
  • •Uncontrolled Diabetic Mellitus and Hypertension •Malignancy.
  • •Impaired Renal Function.
  • •Poorly Functioning Kidney.
  • •Patients with obstruction in urinary passage.
  • •Patients with known metabolic abnormality for calculus formation (Hyperuraecemia).
  • •Any other complication of calculus.

结局指标

主要结局

1.expulsion of the renal calculi

时间窗: 90 days

次要结局

  • 1.ability in reducing the size of the calculi(2.Improved quality of life)

研究者

发起方
Dr K V Chakradhar
申办方类型
Other [Investigator initiated]

研究点 (1)

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