A Randomized, Double Blind, Placebo Controlled, Study to Evaluate the Efficacy and Safety of Cystone Forte Tablet in Urolithiasis – A Pilot Study
试验速览
- 阶段
- 2 期
- 状态
- 已完成
- 入组人数
- 60
- 试验地点
- 1
- 主要终点
- Provide rapid symptomatic recovery.
研究概览
简要总结
This is a randomized double blind placebo controlled clinical study toevaluate the efficacy and safety of Cystone Forte Tablets in Urolithiasis.In this study, 60 cases were enrolled and subjects were instructed to takeInvestigational product in a dose of two tablets twice daily everyday startingfrom day 1 to end of 3 months. Patients were followed up for Clinical assessment,Urine examination and Ultrasonography of abdomen and Pelvis.
All the 60 patients completed the study period without withdrawal.Patients on trial group showed improvement in their symptoms from Month 1onwards till the end of the study.Overall impression by the investigator forCystone forte group is found to be 39% cured, 35% had marked improvement, 19%had moderate improvement, 6% had slight improvement. For placebo group 34% werecured, 24% had marked improvement, 17% had moderate improvement, 3% had slight improvementand 21% had no change .In Cystone forte group, of the 31 stones found duringscreening, 16 stones were expelled out at month 3, of which 14 were <7mm and2 were >7mm. In placebo group, at month 3, 14 stones were expelled out of 29found in screening, out of which 11 were <7mm and 3 were >7mm.
The present study showed that subjects treated with Cystone forte showedimprovement in clinical parameters of urolithiasis and expulsion of kidneystones. Between the group analysis showed that Cystone forte group was found tobe effective and was beneficial in the management of urolithiasis. The studyresults indicate that the polyherbal formulation, Cystone forte, is safe andeffective in the treatment of urolithiasis with significant improvement inclinical symptoms like the clearance of calculi and symptomatic relief. Theefficacy of Cystone forte can be due to the synergistic actions of the potentherbs present in the formulation. The overall compliance to the treatment wasgood and no treatment discontinuations were reported. Additionally, it is alsofound to be beneficial in expelling and/or reducing the size of the renalstones, including bigger-sized stones.
研究设计
- 研究类型
- Interventional
- 分配方式
- Computer generated randomization
- 盲法
- Participant and Investigator Blinded
入排标准
- 年龄范围
- 18.00 Year(s) 至 50.00 Year(s)（—）
- 性别
- All
入选标准
- •Subject with Urolithiasis as diagnosed by clinically and ultrasonographically with calculi measuring 5-10mm.
- •Subjects aged between 18-50 years of either sex.
- •Hematologic and Biochemical parameters within normal limits.
- •Willing to sign inform consent document and follow study procedures.
排除标准
- •1.Subjects with severe obstructive uropathy, 2.Subjects with serious systemic medical disorder, 3.Subjects not to have used any drugs for at least 1 week prior to the study, 4.Subjects with a strong history of food or drug allergy, 5.Subjects not to have been on weight reducing diets within 3 months prior to the start of the study, 6.No other drugs (including aspirin) to be ingested during the course of the study, 7.Pregnant and lactating women 8.Patients unwilling to provide informed consent or abide by the requirements of the study.
结局指标
主要结局
Provide rapid symptomatic recovery.
时间窗: Visit 0- At entry visit, baseline | Visit 1- At the end of month 1 | Visit 2- At the end of month 2 | Visit 3- (End of the treatment) At the end of month 3
To assess the efficacy of Cystone Forte tablet in comparison with placebo in the management of Urolithiasis.
时间窗: Visit 0- At entry visit, baseline | Visit 1- At the end of month 1 | Visit 2- At the end of month 2 | Visit 3- (End of the treatment) At the end of month 3
Reporting of adverse events
时间窗: Visit 0- At entry visit, baseline | Visit 1- At the end of month 1 | Visit 2- At the end of month 2 | Visit 3- (End of the treatment) At the end of month 3
次要结局
- To assess the safety of Cystone forte tablet in the management of Urolithiasis.(Reporting of adverse events)