A Prospective Open Labelled, Single Arm, Non- Randomized, Single Centric, Phase II Clinical Trial to determine the effectiveness of NAVACHARA CHOORANAM in the management of KALLADAIPPU (UROLITHIASIS)
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
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 conducted to determine the effectiveness of NAVACHARA CHOORANAM in the management of KALLADAIPPU (UROLITHIASIS). After proper purification, the trial drug is prepared and administered at a dose of 500 mg with water as an adjuvant for a period of 45 days. A total of 40 diagnosed Urolithiasis patients, including 20 outpatients (OP) and 20 inpatients (IP), are enrolled in the study. The primary outcome of the study is to evaluate the therapeutic efficacy of NAVACHARA CHOORANAM in the management of KALLADAIPPU (UROLITHIASIS). The secondary outcome is to assess the reduction in the size of kidney stones as evidenced by USG abdomen and pelvis findings before and after the trail period.
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 70.00 Year(s)（—）
- 性别
- All
入选标准
- •1.Evidence of renal calculus confirmed by USG 2.Renal colicky pain (loin to groin pain) 3.Nausea, vomiting, sweating 4.Haematuria 5.Dysuria 6.Patients who are willing to undergo radiological investigation and give blood for laboratory investigation.
排除标准
- •1.Chronic Appendicitis 2.Pregnancy and Lactation 3.Pyelonephritis 4.Staghorn stones 5.Chronic Kidney Disease 6.Pelvic Inflammatory Disease 7.Diabetes Mellitus 8.Metabolic disorders like Hyperthyroidism, Hypothyroidism,Hyperparathyroidism.
研究者
DR M TAMIZHL ROSA
Government Siddha Medical College and Hospital