An Open-Label, Parallel-Arm, Multi-Center Clinical Study To Evaluate The Safety And Efficacy Of Ethniq Kidney Care (Uro Fizz Effervescent Tablets And Tea Bags) In Patients With Kidney Stones Or Urinary Tract Infections Or Enlarged Prostate (Benign Prostatic Hyperplasia)

Ethniq Ayush Exports LLP2 个研究点分布在 1 个国家目标入组 100 人开始时间: 2025年4月4日最近更新: 2026年2月10日

试验速览

阶段: 3 期
状态: 尚未招募
发起方
入组人数: 100
试验地点: 2
主要终点: Kidney Stones Arm

研究概览研究设计入排标准结局指标研究者研究点记录与标识符相似试验

研究概览

简要总结

BACKGROUND AND INTRODUCTION

Kidney stones (urolithiasis) and urinary tract infections (UTIs) are common and often interlinked conditions. Kidney stones are mineral deposits in the urinary tract, causing symptoms like severe pain, dysuria, and burning micturition. UTIs, often caused by bacterial infections, lead to frequent urination, pain, and discomfort. Both conditions are prone to recurrence and present management challenges due to side effects and antimicrobial resistance.

Ethniq Kidney Care is a proprietary Ayurvedic formulation designed for kidney stones and UTI management. It includes Uro Fizz Effervescent Tablets (twice daily for 45 days) and complementary Tea Bags, formulated to dissolve stones, promote expulsion, relieve symptoms, and prevent UTIs. Key ingredients include Punarnava, Pashaan Bhed, Gokhru, and Ayurvedic minerals, which provide diuretic, anti-inflammatory, and lithotriptic effects. This holistic approach aims to improve patient outcomes while minimizing the need for invasive treatments.

PURPOSE OF THE STUDY

The purpose of this study is to evaluate the safety and efficacy of Ethniq Kidney Care, a proprietary Ayurvedic formulation, in the management of kidney stones and urinary tract infections (UTIs). The study aims to assess its ability to dissolve kidney stones, promote their expulsion, relieve associated symptoms, prevent UTI complications, and improve overall urinary health. This will be achieved by monitoring symptom relief, urinary parameters, renal function, quality of life, and patient safety over the study 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: 18.00 Year(s) 至 65.00 Year(s)（—）
性别: All

入选标准

•1.Age Male or female patients aged 18 to 65 years for the Kidney Stone and UTI arms.
•Male patients aged 30 to 70 years for the BPH arm.
•2.Diagnosis For the Kidney Stone arm, patients with presence of kidney stones measuring up to twelve millimeters confirmed by ultrasound imaging.
•3.For the UTI arm, patients with presence of urinary tract infection symptoms such as dysuria, frequent urination, or burning during micturition, confirmed by urine culture and sensitivity testing.
•4.For the BPH arm, patients with lower urinary tract symptoms with an International Prostate Symptom Score of eight or more at screening.
•Ultrasound confirmed prostate enlargement with prostate volume of thirty milliliters or more.
•Post void residual urine volume measurable by ultrasound.
•5.General Health Participants should be generally healthy and should not have severe comorbid conditions that may interfere with the study outcomes.
•6.Informed Consent Participants should be willing to voluntarily sign the informed consent form.

排除标准

•1.Severe Medical Conditions Patients with serious cardiovascular, cerebrovascular, respiratory, hepatic, or advanced renal disease.
•Patients with other concurrent urological disorders.
•2.Chronic Conditions Patients with uncontrolled diabetes mellitus.
•Patients with uncontrolled hypertension.
•Patients with symptomatic congestive heart failure.
•3.BPH Arm Patients with history or evidence of prostate cancer.
•Patients with prior prostate or bladder surgery within the last six months.
•Any medical condition that may place the patient at undue risk during study participation.
•4.Pregnancy and Lactation Pregnant or lactating women where applicable.
•5.Substance Abuse Patients with history of excessive alcohol consumption or drug abuse.
•6.Use of Investigational Products Patients who have participated in another clinical trial or used any investigational product within the past thirty days.
•7.UTI Related Exclusions Patients with recurrent urinary tract infections requiring systemic antibiotic treatment during the study period.
•Patients with antibiotic resistant bacterial infections identified during baseline sensitivity testing.
•8.Allergies Patients with known allergy or hypersensitivity to any ingredient of the investigational products including Uro Fizz effervescent tablets or tea bags.