A PROSPECTIVE OPEN LABELLED, SINGLE ARM, NON RANDOMISED SINGLE CENTRIC, PHASE II CLINICAL TRIAL ON ARUGAMPUL VER KUDENEER IN THE MANAGEMENT OF KALLADAIPPU NOI(UROLITHIASIS)
试验速览
- 阶段
- 2 期
- 状态
- 已完成
- 发起方
- 入组人数
- 40
- 试验地点
- 1
- 主要终点
- Oliguria.
研究概览
简要总结
This study is a Prospective Open Labelled, Single arm, Non-Randomized, Single centric, Phase II
clinical trial onARUGAMPUL VEER KUDENEER in the management of KALLADAIPPU NOI(UROLITHIASIS)
The trial drug will be administered orally at the dose of 30_60ml twice a day 45days along with as butteradjuvant in 40 patients. The trial period of 12 months will becarried out in Government Siddha Medical College and Hospital, Palayamkottai, Tirunelveli 627002 , Tamil nadu. The primary outcome will be the evaluation of therapeutic efficacy of the trial drug ARUGAMPUL VEER KUDENEER. The secondary outcome will be the evaluation of Siddha diagnostic parameters,assessment of safety profile of trial drug, assessment of pharmacological and biochemical parameters of the trial drug. In case of any adverse events(AE) is noticed and it will be referred to pharmacovigilance department of SCRI. Further management of patients Will be given in OPD facility.
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
- •Patient with the symptoms of Renal colicky pain Loin to groin pain Nausea Vomiting and sweating Hematuria Oliguria Dysuria.
排除标准
- •Chronic Appendicitis Cholecystitis Pelvic inflammatory disease Chronic Renal Failure Bilateral obstructive uropathy.
结局指标
主要结局
Oliguria.
时间窗: 45 days
Reduction in severity of Renal colicky pain,
时间窗: 45 days
such or be disintegrated and mixed with urine
时间窗: 45 days
will be ensured.
时间窗: 45 days
Reduction of Nausea/vomiting
时间窗: 45 days
Reduction of Hematuria, Polyuria, Dysuria and
时间窗: 45 days
The kidney stone is expelled to come out as
时间窗: 45 days
次要结局
- The secondary outcome is reduction in size of(the kidney stone in USG abdomen and pelvis.)