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CTRI Number  CTRI/2025/03/083360 [Registered on: 25/03/2025] Trial Registered Prospectively
Last Modified On: 10/02/2026
Post Graduate Thesis  No 
Type of Trial  Interventional 
Type of Study   Drug
Ayurveda
Other (Specify) [Kidney Stones and Urinary Tract Infections]  
Study Design  Other 
Public Title of Study
Modification(s)  		 A Clinical Study to Assess the Safety and Effectiveness of Ethniq Kidney Care Products in People with Kidney Stones, Urinary Tract Infections, or Enlarged Prostate 
Scientific Title of Study
Modification(s)  		 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)  
Trial Acronym  Nil 
Secondary IDs if Any
Modification(s)  
Secondary ID  Identifier 
CTSRS/2426 Version No.2.0 Dated 09/Dec/2025  Protocol Number 
 
Details of Principal Investigator or overall Trial Coordinator (multi-center study)  
Name  Ms Arpita Malgi 
Designation  Overall Coordinator and Team lead Clinical Operations 
Affiliation  Samahitha Research Solutions 
Address  Clinical Research Unit, No.1204, "Ashva", 2nd Floor, 26th Main, Jayanagar 9th Block, Bangalore

Bangalore
KARNATAKA
560036
India 
Phone  6364898825  
Fax    
Email  arpita@samahitha.com  
 
Details of Contact Person
Scientific Query  
Name  Ms Sathyavathi L M 
Designation  HOD-Clinical Operations 
Affiliation  Samahitha Research Solutions 
Address  Clinical Research Unit No.1204, Ashva, 2nd Floor, 26th Main,Jayanagar 9th Block,

Bangalore
KARNATAKA
560069
India 
Phone  9739001749  
Fax    
Email  satyalm@samahitha.com  
 
Details of Contact Person
Public Query
Modification(s)  
Name  Ms Mamatha B Gokavi 
Designation  Team Lead - Clinical Operations 
Affiliation  Samahitha Research Solutions 
Address  Clinical Research Unit No.1204, Ashva, 2nd Floor, 26th Main,Jayanagar 9th Block, Bangalore

Bangalore
KARNATAKA
560069
India 
Phone  06364898825  
Fax    
Email  mamatha@samahitha.com  
 
Source of Monetary or Material Support  
Ethniq Ayush Exports LLP D-179, Phase-8b, Sector 74, Chandigarh Sector 55, Rupnagar, S.a.s.nagar (Mohali), Punjab, India, 160055. 
 
Primary Sponsor  
Name  Ethniq Ayush Exports LLP 
Address  D-179, Phase-8b, Sector 74, Chandigarh Sector 55, Rupnagar, S.a.s.nagar (Mohali), Punjab, India, 160055. 
Type of Sponsor  Pharmaceutical industry-Indian 
 
Details of Secondary Sponsor  
Name  Address 
NIL  NIL 
 
Countries of Recruitment     India  
Sites of Study  
No of Sites = 2  
Name of Principal Investigator  Name of Site  Site Address  Phone/Fax/Email 
Dr Shankar S  Bona-fide Ayurvedic Center  LF 16/1, Ground Floor, Opposite to BSNL Office, Near HP Petrol Bunk, Saraswathipura, Nandini Layout, Bengaluru - 560096
Bangalore
KARNATAKA 		 9844669713

shankarsswamy@gmail.com 
Dr Sambashiva  Sri Lakshmi Super Speciality Hospital  #301, Ground Floor, 3rd Main Road, Old Extension, KR Puram, Bangalore - 560036 Bangalore KARNATAKA
Bangalore
KARNATAKA 		 06364898825

drsambashiva.sl@gmail.com 
 
Details of Ethics Committee
Modification(s)  
No of Ethics Committees= 4  
Name of Committee  Approval Status 
Pranav Diabetes Center Ethics Committee   Approved 
Pranav Diabetes Center Ethics Committee   Approved 
Pranav Diabetes Center Ethics Committee   Approved 
Pranav Diabetes Center Ethics Committee   Approved 
 
Regulatory Clearance Status from DCGI  
Status 
Not Applicable 
 
Health Condition / Problems Studied
Modification(s)  
Health Type  Condition 
Patients  (1) ICD-10 Condition:N200||Calculus of kidney. Ayurveda Condition: MUTRAGHATAH, (2) ICD-10 Condition:N390||Urinary tract infection, site notspecified. Ayurveda Condition: MUTRAKRUCCRAM, (3) ICD-10 Condition:N398||Other specified disorders of urinary system. Ayurveda Condition: VATASHTHILA,  
 
Intervention / Comparator Agent  
snoIntervention/ComparatorTypeDrug-TypeProcedure NameDetails
1Intervention ArmDrugOther than Classical(1) Medicine Name: Ethniq Kidney Care (Uro Fizz Effervescent Tablets), Reference: NA, Route: Oral, Dosage Form: Gutika/Vati/Ghana Vati/Tablets, Dose: 1(NA), Frequency: bd, Bhaishajya Kal: Pragbhakta, Duration: 45 Days, anupAna/sahapAna: No, Additional Information: -Patients will take Uro Fizz Effervescent Tablets twice daily, one tablet after breakfast and one after dinner, dissolved in warm water, for a duration of 45 days.
2Comparator ArmDrugOther than Classical(1) Medicine Name: Kidney Care Tea bags, Reference: NA, Route: Oral, Dosage Form: Churna/ Powder, Dose: 1(NA), Frequency: bd, Bhaishajya Kal: Pragbhakta, Duration: 45 Days, anupAna/sahapAna: No, Additional Information: -Patients will be advised to take the Kidney Care Tea bag twice daily for up to 45 days, either along with the effervescent tablet or at any convenient time.
 
Inclusion Criteria
Modification(s)  
Age From  18.00 Year(s)
Age To  65.00 Year(s)
Gender  Both 
Details  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. 
 
ExclusionCriteria 
Details  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. 
 
Method of Generating Random Sequence   Not Applicable 
Method of Concealment   On-site computer system 
Blinding/Masking   Open Label 
Primary Outcome
Modification(s)  
Outcome  TimePoints 
Kidney Stones Arm
Change in kidney stone size and number assessed by ultrasound at baseline and Day forty five.

UTI Arm
Bacterial clearance assessed by urine culture at baseline and Day forty five.

BPH Arm
Change in prostate volume and post void residual urine volume assessed by ultrasound at baseline and Day forty five. 		 Day 0,
Day 15 ± 3
Day 30 ± 3
Day 45±3


 
 
Secondary Outcome
Modification(s)  
Outcome  TimePoints 
Symptom Relief
Improvement in symptoms for kidney stones, UTI, & BPH assessed during follow up visits up to Day forty five.

Kidney Stones Arm
Stone expulsion & renal function assessed at baseline & Day forty five.

Quality of Life
Change in quality of life assessed at baseline & Day forty five.

Safety
Adverse events & renal function monitored throughout the study.

Patient Compliance
Assessed through drug accountability records. 		 Day 0,
Day 15 ± 3
Day 30 ± 3
Day 45±3


 
 
Target Sample Size
Modification(s)  		 Total Sample Size="100"
Sample Size from India="100" 
Final Enrollment numbers achieved (Total)= "Applicable only for Completed/Terminated trials"
Final Enrollment numbers achieved (India)="Applicable only for Completed/Terminated trials" 
Phase of Trial   Phase 3 
Date of First Enrollment (India)   04/04/2025 
Date of Study Completion (India) Applicable only for Completed/Terminated trials 
Date of First Enrollment (Global)  Date Missing 
Date of Study Completion (Global) Applicable only for Completed/Terminated trials 
Estimated Duration of Trial   Years="0"
Months="1"
Days="15" 
Recruitment Status of Trial (Global)   Not Yet Recruiting 
Recruitment Status of Trial (India)  Not Yet Recruiting 
Publication Details   N/A 
Individual Participant Data (IPD) Sharing Statement

Will individual participant data (IPD) be shared publicly (including data dictionaries)?  

Response - NO
Brief Summary   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.

 
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