A Prospective, Open label, Single-Arm Study to Evaluate the Efficacy of Unani Formulations in the Management of Hasah aL-Kulya (Renal calculus)
试验速览
- 阶段
- 2 期
- 状态
- 尚未招募
- 发起方
- 入组人数
- 40
- 试验地点
- 1
- 主要终点
- Pain in flank region
研究概览
简要总结
Renal stone or calculus is one of the most common disease of urinary tract. it occurs more frequently in men than in women, white than in black and it shows familial predisposition.
Urinary stone is a stone like body composed of urinary salts bound together by a colloidal matrix of organic material it consist of a nucleus around which concentric layers of urinary salts are deposited.
the primary purpose of protocol is to outline standardized procedure for diagnosing, managing and treating renal stone patient.
The protocol aims to provide a clear framework for assessing symptoms, evaluating the severity of the condition , and implementing appropriate interventions to improve patient outcomes and quality of life. this may include life style modification, Diet modification, Medication depending on the severity of the symptoms.
Urinary calculi has its roots deeply embedded in urological literature. treatment have changed drastically over the centuries, from lithotripsy to open surgical procedure to removal of stone.
Nephrolithiasis or renal calculus affect approximately 15% population worldwide and about 2.3 % population of India. it affects all age groups from less than 1 year of age to more than 70 years of age, with male female ratio 2:1.
Urinary stone are among one of the most significant cause of morbidity and end stage renal failure. its rate of recurrence in male is about 70-81% and in female 47-60%.
Despite of various technological advent ages in minimal invasive therapy in treatment of renal stone like ESWL, Percutaneous nephrolithotomy the management of renal stone remain challenge due to high cost, adverse effect and complication of minimal invasive technique.
The study aims to assess whether these Unani compound formulations can offer significant benefit in alleviating symptoms, improving urinary function and removal of stone.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 盲法
- None
入排标准
- 年龄范围
- 20.00 Year(s) 至 60.00 Year(s)(—)
- 性别
- All
入选标准
- •Diagnosed case of Hasah al kulya ( Renal calculus ) upto 10 mm ( Radiological evidence ) Patients who have agreed to sign the informed consent form and follow up the protocol .
排除标准
- •Patients diagnosed as stone size more than 10 mm or location other than kidney .
- •urinary bladder outlet obstruction Known cases of Diabetes mellitus and any serious systemic illness.
- •Patients having any type of malignancy Pregnant and lactating women.
- •Any acute or chronic kidney disease.
- •Mentally retarted patient.
- •Patient having severe flank pain, gross haematuria, severe hydroureteronephrosis and deranged RFT Patient who fail to give consent.
结局指标
主要结局
Pain in flank region
时间窗: Day 0, 15th 30th | 45th
Burning micturition
时间窗: Day 0, 15th 30th | 45th
Haematuria
时间窗: Day 0, 15th 30th | 45th
Nausea/ vomiting
时间窗: Day 0, 15th 30th | 45th
Frequency of micturition
时间窗: Day 0, 15th 30th | 45th
次要结局
- USG whole abdomen(Urine R/M)
研究者
DR TABISH SHAMSHI
DEPARTMENT OF ILMUL JARAHAT STATE TAKMEEL UTTIB COLLEGE AND HOSPITAL
