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临床试验/CTRI/2022/11/047788
CTRI/2022/11/047788招募中2 期

A PROSPECTIVE STUDY ON THE EFFECT OF HOMOEOPATHIC MEDICINES IN THE MANAGEMENT OF UROLITHIASIS BY ASSESSING ULTRASONOGRAM (KUB)

SAHLA VP1 个研究点 分布在 1 个国家目标入组 35 人开始时间: 2022年4月12日最近更新:

试验速览

阶段
2 期
状态
招募中
发起方
入组人数
35
试验地点
1
主要终点
1) Significant difference in the Urolithiasis symptom score before and after homeopathic treatment in the subjects with Urolithiasis

研究概览

简要总结

The process of forming stone in urinary tract i.e., in the kidney ,bladder, and ureter is referred to as Urolithiasis. Urolithiasis is one of the most painful and the most common disorders of the urinary tract. 80% of stones are composed of calcium oxalate or phosphate. Other stone types include uric acid (9%), struvite (10%), and cystine (1%) stones.

It is common, among people of all countries and ethnic groups. It affects about 12% of the world population at some stage in their lifetime  . In India, approximate 50% of the population is affected with renal calculi, which may end up to renal damage or loss of kidney function . In the UK, the prevalence is about 1.2%, with a lifetime risk of developing a renal stone by age of  60–70. In some regions, the risk is higher, most notably in countries such as Saudi Arabia, where the lifetime risk of developing a renal stone in men aged 60–70 .

Around 97% of urinary stones are found in the kidneys and ureters (kidney stones), the remaining 3% in the urinary bladder and urethra. Urinary stones can range in size from micrometers to several centimeters in diameter. They frequently remain unnoticed for long periods before manifesting themselves—often very painfully—or being discovered incidentally on radiography or ultrasound.

Common risk factors for stone formation include poor oral fluid intake, high animal-derived protein intake, high oxalate intake (found in foods such as beans, beer, berries, coffee, chocolate, some nuts, some teas, soda, spinach, potatoes), and high salt intake.

The mechanism of stone formation is a complex process which results from several physicochemical events including supersaturation, nucleation, growth, aggregation, and retention of urinary stone constituents within tubular cells. These steps are modulated by an imbalance between factors that promote or inhibit urinary crystallization

It commonly presents with flank pain, hematuria, and nausea/vomiting. Focused evaluation with history, examination, and testing is important in diagnosis and management. Ultrasound examination is the most useful investigation to detect the presence, severity and site of obstruction due to stone. It is non-invasive and can be performed repeatedly. Plain X-ray abdomen for kidney, ureter, bladder and urethra (KUBU) will detect the radiopaque stones. Intravenous urography (IVU) helps to assess the renal function apart from detecting the radiolucent stones as filling defect and the level of obstruction.

When we check the intensity of  the suffering and it’s recurrence rate, there  arises an alarming need for better treatment which is cost effective and prevent further stone formation.

RATIONALE OF THE STUDY

Shock wave lithotripsy (SWL) is the process of fragmentation of renal or ureteric stones by the use of repetitive shock waves generated outside the body and focused onto the stone.. SWL results in injury to the kidney which may have long-term side effects, such as new onset hypertension.. Currently, use of lithotripsy is waning, particularly with the advent of minimally invasive ureteroscopic approaches.

SWL can cause vascular trauma to the kidney and surrounding organs. This acute SW damage can be severe, can lead to scarring with a permanent loss of functional renal volume, and has been linked to potentially serious long-term adverse effects. A recent retrospective study linking lithotripsy to the development of diabetes mellitus has further focused attention on the possibility that SWL may lead to life-altering chronic effects.

Extracorporeal shockwave lithotripsy (ESWL) devices, new flexible ureterorenoscopes, development of laser fragmentation, semi-rigid and flexible ureteroscopy and the percutaneous nephrolithotomy (PCNL) remain currently the main therapeutic options.

For stones less than 20mm, extracorporeal lithotripsy remains the standard, but in some cases the possibility of recommending a flexible ureterorenoscopy is possible in first line. For stones more than 20mm, percutaneous nephrolithotomy is the standard treatment, but optional flexible ureteroscopy and extracorporeal lithotripsy are possible

Homeopathy being an individualistic and holistic system of medicine  it can relieve the pain, dissolve the stone, and prevent recurrence and formation of calculi. Rather than treating each condition separately, a constitutional approach can be adopted in Homeopathy. This study is  a honest attempt aimed towards the relief of symptoms and suffering of pateints with urolithiasis.

研究设计

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

入排标准

年龄范围
20.00 Year(s) 至 65.00 Year(s)(—)
性别
All

入选标准

  • 1.Age group from 20- 70years of both sexes.
  • 2.Symptomatic cases of Urolithiasis diagnosed by ultrasonogram(KUB) 3.Size of the stone ranging from 3mm to 20 mm.

排除标准

  • 1.Cases impacted or with stag horn calculi 2.Gross developmental or structural abnormalities of urinary system(like urethral stricture) 3.Subject of pregnant and lactating women 4.Patients with severe systemic illness like malignancies.
  • 5.Patients who need emergency management.

结局指标

主要结局

1) Significant difference in the Urolithiasis symptom score before and after homeopathic treatment in the subjects with Urolithiasis

时间窗: 6 MONTHS

2) Significant changes in USG(KUB) before and after homeopathic treatment in the subjects with Urolithiasis

时间窗: 6 MONTHS

次要结局

  • Significant difference in the Urolithiasis symptom score before and after homeopathic treatment in the subjects with Urolithiasis

研究者

发起方
SAHLA VP
申办方类型
Other [self]

研究点 (1)

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