A PROSPECTIVE STUDY TO EVALUATE THE EFFICACY AND SAFETY OF AN AYURVEDIC FORMULATION - URAL CAPSULE IN THE TREATMENT OF UROLITHIASIS
试验速览
- 阶段
- 2 期
- 状态
- 招募中
- 入组人数
- 60
- 试验地点
- 1
- 主要终点
- Efficacy of trial drug on urolithiasis
研究概览
简要总结
Stone formation in kidney is one of the oldest and the mostwidespread medical afflictions known to humans. It is a most common urinarytract problem all over the world, having prevalence rate of 2.3%. Patientsbetween ages of 20-50 years have peak incidence of stone formation. In India,6-8% population suffers from kidney stone. Ural Capsule is a patent &proprietary Ayurvedic formulation, recommended for treatment of urolithiasis.Previous experimental data has confirmed its safety and efficacy. Hence thepresent study is to be initiated to evaluate its clinical safety and efficacy.Open labelled, interventional clinical trial protocol has been designed toevaluate efficacy and safety of Ural Capsule in treatment of urolithiasis.Inclusion and exclusion criteria have been mentioned in protocol for selectionof patients. All selected patients will be treated with Ural Capsule for 3months (12 Weeks). For the assessment of efficacy different clinical parameterssuch as subjective parameters, Blood urea, Serum uric acid, Serum creatinine,X-ray (KUB) & Ultrasonography (KUB) will be considered. Routinehaematological parameters, routine urine analysis and routine stool analysiswill be done to evaluate safety of the drug. Follow-up visit will be scheduled at1 month interval after compilation of treatment up to 2 months. Appropriatestatistic will be applied to find out statistical significance level.
KeyWords : Ashmari,Urolithiasis, Kidney stones, Uralcapsule**.**
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
- 18.00 Year(s) 至 60.00 Year(s)(—)
- 性别
- All
入选标准
- •(1) Patients of both sexes in the age group of 18 to 60 years will be selected for the present study.
- •(2) Patients who willing to sign written consent and comply with the study procedure.
- •(3) Patients having stone in kidney / ureter / bladder (KUB) greater than 5 mm but < 12 mm in size.
排除标准
- •(1) Patients below 18 years and above 60 years (2) Patients having uretero-hydronephrosis, diabetes, ulcer disease, history of hypersensitivity to herbal formulation (3) Patients suffering from serious systemic disorders (4) Patients with severe complication and requiring immediate surgery (5) Pregnant or lactating women (6) Patients who are unwilling to give informed consent.
结局指标
主要结局
Efficacy of trial drug on urolithiasis
时间窗: 3 months clinical trial and 2 months follow up
次要结局
- Safety of the trial drug(During treatment and in follow up)
