CTRI/2019/04/018423已完成3 期
An Open Label, Prospective, Non-Comparative, Single Arm Clinical Study to Evaluate the Efficacy, Safety and Tolerability of Stonvil Capsules in the Treatment of Renal Calculi
SG Phyto Pharma Pvt Ltd0 个研究点目标入组 46 人开始时间: 待定最近更新:
试验速览
- 阶段
- 3 期
- 状态
- 已完成
- 发起方
- 入组人数
- 46
研究概览
简要总结
暂无简介。
研究设计
- 研究类型
- Interventional
入排标准
入选标准
- •1.Adult subjects >=18 years of age diagnosed with Renal Calculi (both sexes inclusive)
- •2.Renal Calculi to be confirmed by USG. A minimum of 1 calculi; sized >=3mm with crystals.
- •3.Subject/LAR who is willing to give informed consent for participation, able to comprehend and understand the responsibilities during treatment period and follow up period.
- •4.Subjects who are willing not to participate in any other clinical trial during participation in the current trial.
排除标准
- •1.Subjects with known hypersensitivity to herbal investigational product or its constituents.
- •2.Subjects who require or are scheduled for or have previously undergone lithotripsy.
- •3.Subjects with calculus condition requiring surgery; not limited to hydronephrosis, hydrocalycosis; struvite and cystic stones
- •4.Subjects with current or chronic infection not limited to urinary tract infection; chronic renal infection.
- •5.Subjects with clinically abnormal renal function parameters that are to deemed by the Investigator/ CRMC as interfering with the study objectives.
- •6.Subjects on medications/herbal supplements for renal calculi.
- •7.Subjects with immunucompromised state complications.
- •8.Subjects with uncontrolled diabetes, hypertension or congestive heart failure.
- •9.Any significant medical condition (e.g., significant psychiatric or neurological disorders, active alcohol/drug abuse, etc.), any medical condition that is unstable/poorly controlled or other factor (e.g., planned relocation) that the Investigator felt would interfere with study evaluations and study participation.
- •10.Subjects who have participated in any clinical study within 3 months from the date of enrolment.
- •11.Females who are pregnant or lactating or planning to become pregnant during the study period.
- •12.Subjects who mentally unable to comprehend the responsibilities and adhere to the stipulations of the protocol.
- •13.Subjects, who in the opinion of the Investigator/CRMC are not eligible for enrolment in the study.
研究者
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