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CTRI Number  CTRI/2025/09/094132 [Registered on: 02/09/2025] Trial Registered Prospectively
Last Modified On: 06/02/2026
Post Graduate Thesis  No 
Type of Trial  Interventional 
Type of Study   Drug
Ayurveda
Other (Specify) [Stonequit tablet for the treatment of Urinary Stones]  
Study Design  Single Arm Study 
Public Title of Study   A study to evaluate if the Stonequit tablet is safe and effective in the treatment of Urinary Stones 
Scientific Title of Study   An Open-Label, Single-Arm, Single-Center Clinical Study to Evaluate the Safety and Efficacy of Stonequit Tablet in Subjects with Urinary Stones 
Trial Acronym  Nil 
Secondary IDs if Any  
Secondary ID  Identifier 
CTSRS/2510 Version No 1.0 Dated 07 May 2025  Protocol Number 
 
Details of Principal Investigator or overall Trial Coordinator (multi-center study)  
Name  Dr Deepak M 
Designation  Principal Investigator 
Affiliation  Sri Lakshmi Super Speciality Hospital 
Address  Room No.1, OPD Ground Floor, 301, 3rd Main Road, near Indane Gas, V B Layout, Old Extension, Krishnarajapuram

Bangalore
KARNATAKA
560036
India 
Phone  6364898825  
Fax    
Email  drdeepakm1994@gmail.com  
 
Details of Contact Person
Scientific Query  
Name  Ms Sathyavathi LM 
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  09739001749  
Fax    
Email  satyalm@samahitha.com  
 
Details of Contact Person
Public Query  
Name  Ms Arpita Malgi 
Designation  Team Lead - 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  6364898825  
Fax    
Email  arpita@samahitha.com  
 
Source of Monetary or Material Support  
UMA Ayurvedic Private Limited Panchvati, Madhavpuri, Kasganj, Uttar Pradesh 207123 
 
Primary Sponsor  
Name  UMA Ayurvedic Private Limited 
Address  Panchvati, Madhavpuri, Kasganj, Uttar Pradesh 207123 
Type of Sponsor  Pharmaceutical industry-Indian 
 
Details of Secondary Sponsor  
Name  Address 
NIL   
 
Countries of Recruitment     India  
Sites of Study  
No of Sites = 1  
Name of Principal Investigator  Name of Site  Site Address  Phone/Fax/Email 
Dr Deepak M  Sri Lakshmi Super Speciality Hospital   Room No. 1, OPD Ground Floor, 301, 3rd Main Road, near Indane Gas, V B Layout, Old Extension, Krishnarajapuram, Bangalore
Bangalore
KARNATAKA 		 6364898825

drdeepakm1994@gmail.com 
 
Details of Ethics Committee  
No of Ethics Committees= 1  
Name of Committee  Approval Status 
Pranav Diabetes Center Ethics Committee  Approved 
 
Regulatory Clearance Status from DCGI  
Status 
Not Applicable 
 
Health Condition / Problems Studied  
Health Type  Condition 
Patients  (1) ICD-10 Condition:N22||Calculus of urinary tract in diseases classified elsewhere. Ayurveda Condition: MUTRAKRUCCRAM,  
 
Intervention / Comparator Agent  
snoIntervention/ComparatorTypeDrug-TypeProcedure NameDetails
1Intervention ArmDrugOther than Classical(1) Medicine Name: Stonequit Tablet, Reference: NA, Route: Oral, Dosage Form: Gutika/Vati/Ghana Vati/Tablets, Dose: 625(mg), Frequency: bd, Bhaishajya Kal: Adhobhakta, Duration: 45 Days, anupAna/sahapAna: Yes(details: Water), Additional Information: Subjects are instructed to take the medication with sufficient amount of lukewarm water
 
Inclusion Criteria  
Age From  18.00 Year(s)
Age To  75.00 Year(s)
Gender  Both 
Details  1.Adults aged 18 to 75 years, of either gender
2.Diagnosis of urinary stones confirmed by ultrasound scan
3.Size of the urinary stones must be less than 15mm in maximum diameter
4.Subjects who are first time stone formers or with a history of recurrent urinary stones, presenting with symptoms such as flank pain, dysuria, or hematuria
5.Willingness to comply with the study protocol and attend all scheduled visits
6.Ability and willingness to provide written informed consent 
 
ExclusionCriteria 
Details  1.Pregnant or lactating women
2.Subjects with any systemic disease requiring other medications or surgical intervention for their calculus condition
3.Body Mass Index which is greater than 40 kg per meter square due to the impact on hydration and metabolic balance
4.Cases requiring immediate surgical management or presenting with complicated urolithiasis
5.Active urinary tract infection or chronic renal infection
6.Subjects with uncontrolled diabetes mellitus, hypertension, symptomatic congestive heart failure, unstable angina, or recent myocardial infarction
7.Presence of other urogenital disorders that may interfere with outcomes
8.Use of any herbal or plant-based supplement for kidney stones within the past 3 months
9.Participation in another clinical study within 30 days prior to screening
10.Active alcohol or substance abuse, or history of the same within the last 24 weeks
11.Any psychiatric illness or condition that may affect adherence to the protocol
12.Any other medical condition, in the investigator’s opinion, that could compromise the safety of the Subject or study integrity
 
 
Method of Generating Random Sequence   Not Applicable 
Method of Concealment   Not Applicable 
Blinding/Masking   Open Label 
Primary Outcome  
Outcome  TimePoints 
1.The Change in urinary stone size and number from Baseline to the End-of-Treatment, as measured by ultrasound imaging.
Stone Size: Measured in millimeters using standardized ultrasonographic techniques.
Stone Number: Total count of stones present in the kidney, ureter, or bladder.
2.Rationale: Reduction in stone burden is the most objective and clinically relevant marker of treatment efficacy in urolithiasis management.
 		 Day 0, Day 15, Day 30, Day 45 
 
Secondary Outcome  
Outcome  TimePoints 
1.Symptom Relief: Improvement in urinary stone-related symptoms, assessed using the Visual Analog Scale.
2.Change in Quality of Life score from Baseline to End-of-Treatment, assessed using a validated disease-specific QoL questionnaire.
Safety Endpoints:
1. Incidence of Adverse Events (AEs) and Serious Adverse Events (SAEs) will be monitored throughout the study duration.
2. Changes in hematological and renal function parameters including CBC and RFT will be assessed at Baseline (Day 0) and End-of-Treatment (Day 45). 		 Day 0, Day 15, Day 30, Day 45 
 
Target Sample Size   Total Sample Size="60"
Sample Size from India="60" 
Final Enrollment numbers achieved (Total)= "60"
Final Enrollment numbers achieved (India)="60" 
Phase of Trial   Phase 3 
Date of First Enrollment (India)   13/09/2025 
Date of Study Completion (India) 21/12/2025 
Date of First Enrollment (Global)  Date Missing 
Date of Study Completion (Global) Date Missing 
Estimated Duration of Trial   Years="0"
Months="1"
Days="15" 
Recruitment Status of Trial (Global)   Not Applicable 
Recruitment Status of Trial (India)  Completed 
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
Modification(s)  		 Background
Urolithiasis commonly known as urinary stone disease is one of the most prevalent urological disorders affecting 12-15% of the global population with a recurrence seen in 50% of the Subjects within 5 years. It is a condition that occurs due to supersaturation of urinary solutes such as calcium oxalate, uric acid, and phosphate leading to crystal formation in the kidneys, ureters, or bladder. It occurs due to lifestyle, dietary habits, low water intake, and climatic factors and these are considered to have contributed to the growing burden of urolithiasis in India. Management of this includes increased fluid intake, pain management, and surgical procedures like lithotripsy or ureteroscopy. However, these approaches do not guarantee prevention of recurrence, and some may be associated with high costs, procedural risks, and adverse effects. Ayurveda offers holistic and time-tested remedies for the urinary disorders including urolithiasis.  
Stonequit Tablet a proprietary Ayurvedic Medicine is designed not only to help break and eliminate existing stones but also to reduce pain, inflammation, dysuria and prevent recurrence. Traditional usage and clinical experience have indicated promising outcomes. However, a scientific validation through a well-designed clinical trial to evaluate the safety and efficacy of the product is needed.
Purpose of the study
The purpose of this phase 3 clinical study is to evaluate the safety and effectiveness of Stonequit Tablet in reducing the size and number of urinary stones. It also aims to assess improvement in urinary stone-related symptoms using Visual Analogue Scale and improvement in Subject QoL using a QOL Questionnaire.

Result of the study:
A total of 60 participants with urinary stones were enrolled in the study. Out of these 58 participants completed the study and 2 participants were lost to follow up.

The mean age of the participants was 40.9 years and the mean body mass index was 27.34 kg per meter square. Both male and female participants were included in the study.

After 45 days of treatment with Stonequit Tablet a clear improvement was observed in all primary and secondary outcome measures.

Primary Outcome

There was a reduction in urinary stone size and number from baseline to Day 45 as assessed by ultrasonography.
The mean stone size reduced from 9.68 mm at baseline to 6.78 mm at Day 45.
The mean number of stones reduced from 1.57 at baseline to 0.88 at Day 45.
These findings indicate a significant reduction in overall stone burden after treatment.

Secondary Outcomes

There was a consistent improvement in urinary stone related symptoms such as abdominal or flank pain burning micturition hematuria nausea and vomiting.
The mean total symptom score based on visual analog scale reduced from 29.6 at baseline to 13.1 at Day 45 showing marked symptom relief.

Quality of life assessment showed improvement across all domains including urinary discomfort physical activity sleep quality social functioning psychological well being daily activities and overall quality of life by the end of the treatment period.

Safety Results

The treatment was well tolerated throughout the study. No serious adverse events were reported. All participants showed stable vital signs and laboratory parameters. Hematological and renal function parameters remained within normal limits indicating good safety of the study product.

Conclusion

The study results demonstrate that Stonequit Tablet is safe and effective in reducing urinary stone size and number and in improving symptoms and quality of life in subjects with urinary stones over a treatment period of 45 days.


 
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