An open-label, randomized, single center prospective study to evaluate the efficacy & safety of a polyherbal NEERI® Tablet and Syrup in patients with renal calculi disease
试验速览
- 阶段
- Unknown
- 状态
- 尚未招募
- 发起方
- 入组人数
- 30
- 试验地点
- 1
- 主要终点
- •Change in the size of renal stones from baseline to end of the study assessed by using ultrasound sonography (USG).
研究概览
简要总结
Urinary calculi (stones) are solid crystalline massesthat form in the urinary tract. Urinary stones affect approximately 2-5% of theAsian population, and the risk of recurrence is also high. Approximately 60–85% of human stones are calcium oxalate, calciumphosphate, or both. Several factors influence kidney stone formation, includingmetabolic changes, lack of stone-inhibiting factors, and salt-saturated urinestatus .NEERI® Tablet and Syrup are the polyherbal formulations for thetreatment of various renal problems, including renal calculi, urinary tractinfections (UTIs), dysuria, and benign prostatic hyperplasia.
An open-label, randomized, single center prospective study to evaluatethe efficacy and safety of a polyherbal NEERI® Tablet and Syrup inpatients with renal calculi disease.Thestudy will last approximately 120 days (4 months). Each patient will receive 120days of treatment. Atotal of 30 evaluable subjects are planned to enrol in this study. Recruitmentand treatment of subjects is expected to be performed in a single study center. According to the randomization code, eligible patientswill be assigned in a 1:1 ratio to one of the study groups, i.e., each group willhave 15 subjects.
研究设计
- 研究类型
- Interventional
- 分配方式
- Computer generated randomization
- 盲法
- Open Label
入排标准
- 年龄范围
- 18.00 Year(s) 至 65.00 Year(s)（—）
- 性别
- All
入选标准
- •1.Participants of either sex aged 18 to 65 years 2.Willing to sign informed consent and comply with the requirements of the study protocol 3.Participants with diagnostic reports (plain X-ray, ultrasound sonography, or CT scan) for renal calculi.
- •4.Participants with the calculi size ranging from 4 mm to less than 10 mm.
排除标准
- •1.Pregnant and lactating women 2.Known allergies to any component of the study intervention.
- •3.Patients with acute or complicated conditions of kidney stones.
- •4.Subjects who have taken other drugs or herbal supplements for stone disease in the previous 3 months.
- •5.Participants with chronic or active disease, such as kidney failure, liver disorder, cancer, myocardial infarction, uncontrolled diabetes, uncontrolled hypertension, symptomatic congestive heart failure, and chronic kidney infection.
- •6.Evidence of significant concomitant disease that, in the view of the principal investigator, that would prevent patient participation 7.Participants suffering from a mental illness or other condition that would make it difficult to meet the study requirements.
结局指标
主要结局
•Change in the size of renal stones from baseline to end of the study assessed by using ultrasound sonography (USG).
时间窗: day -2, day 0, day 60, day 120
•Change in the number of renal stones from baseline to end of the study assessed by using USG.
时间窗: day -2, day 0, day 60, day 120
次要结局
- •Mean change in the symptom severity score from screening to end of the study(•Mean changes in the levels of serum calcium, serum phosphorous, serum magnesium & serum uric acid and oxalate in urine from screening to end of the study)