A Prospective, Interventional, Randomized, Double-blind, Placebo-controlled, Clinical study to evaluate the Efficacy and Safety of Clearstone syrup (sugar free) in Patients with Asymptomatic Renal calculi. - NI

SBL Pvt. Ltd0 个研究点目标入组 0 人开始时间: 待定最近更新: 2024年8月19日

试验速览

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•1. Both male and female patients aged 18-70 years with a diagnosis of renal stone size upto 10mm confirmed by non-contrast computerized tomography (CT) scan.
•2. Able and willing to give written informed consent and comply with the requirements of the study protocol.
•3. Female participants of child bearing potential with negative serum pregnancy test at screening and negative urine pregnancy test at check-in.
•4. Male participants with female partners of child-bearing potential must agree to abstinenceif this is in line with the usual lifestyle, or to use condoms plus partner use of an acceptable contraceptive for the duration of the study and until 4 weeks after dosing with the study drug.
•5. Patients will to cooperate and give consent for the trial and comes for regular follow up.

•1. Patients with complications and requiring surgical interventions.
•2. Patients with high values of serum creatinine, serum glutamic pyruvic transaminase, serum glutamic oxaloacetic transaminase, alkaline phosphatase and HbA1c at screening.
•3. Any systemic disease requiring other medications of surgery for calculus condition.
•4. Complicated cases of Renal calculi requiring surgical condition.
•5. Chronic or current infectious diseases such as but not limited to chronic renal infection, Uncontrolled diabetes, hypertension, symptomatic congestive heart failure, unstable angina pectoris , myocardial infarction.

发起方

SBL Pvt. Ltd