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CTRI Number  CTRI/2026/05/110176 [Registered on: 07/05/2026] Trial Registered Prospectively
Last Modified On: 03/04/2026
Post Graduate Thesis  Yes 
Type of Trial  Interventional 
Type of Study   Drug 
Study Design  Single Arm Study 
Public Title of Study   A Study on How Madhuyashtyadi Syrup Helps in Treating Urinary Tract Infections in Children 
Scientific Title of Study   Single Arm Clinical Study To Evaluate The Efficacy Of Madhuyashtydi Syrup In The Management Of Pittaj Mutrakruchhra With Special Reference To UTI In Children 
Trial Acronym  NIL 
Secondary IDs if Any  
Secondary ID  Identifier 
NIL  NIL 
 
Details of Principal Investigator or overall Trial Coordinator (multi-center study)  
Name  Dr Gayatri Rajendrakumar Takawale 
Designation  PG Scholar 
Affiliation  LRP Ayurvedic Medical College Urun Islampur 
Address  LRP Ayurvedic Medical College and Hospital PG Institute and Research Centre Urun Islampur Kaumarbhritya Department OPD 2 Sangli Maharashtra 415409
LRP Ayurvedic Medical College and Hospital PG Institute and Research Centre Urun Islampur Kaumarbhritya Department OPD 2 Sangli Maharashtra 415409
Sangli
MAHARASHTRA
415409
India 
Phone  7559130959  
Fax    
Email  gayatritakawale6@gmail.com  
 
Details of Contact Person
Scientific Query
 
Name  Dr Jyotsna Ahir  
Designation  HOD & Professor 
Affiliation  LRP Ayurvedic Medical College Urun Islampur 
Address  LRP Ayurvedic Medical College and Hospital PG Institute and Research Centre Urun Islampur Kaumarbhritya Department OPD 2 Sangli MAHARASHTRA 415409
LRP Ayurvedic Medical College and Hospital PG Institute and Research Centre Urun Islampur Kaumarbhritya Department OPD 2 Sangli MAHARASHTRA 415409 India Sangli MAHARASHTRA
Sangli
MAHARASHTRA
415409
India 
Phone  7276538181  
Fax    
Email  drjyotsnaahir@gmail.com  
 
Details of Contact Person
Public Query
 
Name  Dr Jyotsna Ahir 
Designation  HOD & Professor 
Affiliation  LRP Ayurvedic Medical College Urun Islampur 
Address  LRP Ayurvedic Medical College and Hospital PG Institute and Research Centre Urun Islampur Kaumarbhritya Department OPD 2 Sangli MAHARASHTRA 415409
LRP Ayurvedic Medical College and Hospital PG Institute and Research Centre Urun Islampur Kaumarbhritya Department OPD 2 Sangli MAHARASHTRA 415409
Sangli
MAHARASHTRA
415409
India 
Phone  7276538181  
Fax    
Email  drjyotsnaahir@gmail.com  
 
Source of Monetary or Material Support  
LRP Ayurvedic medical college and hospital, PG Institute and Research center, Urun Islampur 415409  
 
Primary Sponsor  
Name  Loknete Rajarambapu Patil Ayurvedic medical college,Islampur 
Address  LRP Ayurvedic Medical College And Hospital PG Institute and Research Centre Islampur Maharashtra 415409 
Type of Sponsor  Research institution and hospital 
 
Details of Secondary Sponsor  
Name  Address 
NIL  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 Gayatri Takawale  Loknete Rajarambapu Patil Ayurvedic medical college  LRP Ayurvedic Medical College and Hospital PG Institute and Research Centre Urun Islampur Kaumarbhritya Department OPD 2 Sangli Maharashtra 415409
Sangli
MAHARASHTRA 
07559130959

gayatritakawale6@gmail.com 
 
Details of Ethics Committee  
No of Ethics Committees= 1  
Name of Committee  Approval Status 
Prakash Shikshan Mandals, Loknete Rajarambapu Patil Ayurvedic Medical College, Hospital, Post Graduate Institute and Research Center, Islampur.   Approved 
 
Regulatory Clearance Status from DCGI  
Status 
Not Applicable 
 
Health Condition / Problems Studied  
Health Type  Condition 
Patients  (1) ICD-10 Condition:N390||Urinary tract infection, site notspecified. Ayurveda Condition: PITTAJAMUTRAKRUCCRAM,  
 
Intervention / Comparator Agent  
snoIntervention/ComparatorTypeDrug-TypeProcedure NameDetails
1Intervention ArmDrugClassical(1) Medicine Name: Madhuyashtydi Syrup, Reference: Kashyap Samhita (Vruddhajivikiyatantra),chikitsasthan,Adhyay Mutrakruchchrachiktsa Shlok no.9, Route: Oral, Dosage Form: Sharkara/ Syrup, Dose: 1.4(ml), Frequency: bd, Bhaishajya Kal: Adhobhakta, Duration: 7 Days, anupAna/sahapAna: Yes(details: jal), Additional Information: Dose Will be calculated by clarks formula according to weight
 
Inclusion Criteria  
Age From  6.00 Year(s)
Age To  14.00 Year(s)
Gender  Both 
Details  Age group between 6 to 12 years.Patients irrespective of their gender, religion & economic status will be Included in study.Patients with symptoms of Pittajmutrakruchchra.Patients agreed for treatment and within inform consent.  
 
ExclusionCriteria 
Details  Patients below age 6 and above 14 years.Patients with congenital abnormalities.Patients with phimosis, hematuria, renal failure, nephrotic syndrome. Patients with renal tuberculosis, acute glomerulonephritis, renal calculi.  
 
Method of Generating Random Sequence   Other 
Method of Concealment   Other 
Blinding/Masking   Open Label 
Primary Outcome  
Outcome  TimePoints 
To Study the efficacy of Madhuyashtydi Syrup in the management of pittaj mutrakruchhra with special reference to Urinary tract infection in Children  7 days 
 
Secondary Outcome  
Outcome  TimePoints 
1 To Study Mutrakruccha in detail according to ayurveda

2 To Study U.T.I according to Modern Science

3 To Study the Syrup Kalpana

4 To Study the Preparation of Madhuyashtydi Syrup

5 To Study the action of Madhuyashtydi Syrup in Mutrakruccha 
7 Days study with follow up on 3rd & 7th day  
 
Target Sample Size   Total Sample Size="30"
Sample Size from India="30" 
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 2/ Phase 3 
Date of First Enrollment (India)   20/08/2026 
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="1"
Months="6"
Days="0" 
Recruitment Status of Trial (Global)   Not Applicable 
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  
Urinary tract infections (UTIs) are among the most common bacterial infections in the pediatric population, contributing significantly to morbidity. They present with symptoms such as dysuria, increased frequency of micturition, lower abdominal pain, and fever, and may lead to recurrent infections and renal complications if inadequately treated. The rising incidence of antimicrobial resistance and recurrence has necessitated the exploration of alternative and adjunct therapeutic options.
In Ayurvedic literature, the clinical features of UTI can be correlated with Pittaj Mutrakruchhra, characterized by symptoms like daha (burning micturition), mutradaha, peeta mutrata, and alpa-alpa mutrapravritti. Madhuyashtyadi Syrup, a classical Ayurvedic formulation, possesses properties such as sheeta virya, pitta-shamaka, mutrala, and vrana shodhana, which may help in alleviating inflammation, reducing urinary discomfort, and promoting urinary tract health.
Purpose of the Trial
The present single-arm clinical study is designed to evaluate the efficacy of Madhuyashtyadi Syrup in the management of Pittaj Mutrakruchhra with special reference to urinary tract infections in children. The study aims to assess its effect on clinical symptoms (such as dysuria, frequency, and burning micturition) and relevant laboratory parameters (e.g., urine routine and microscopy). Additionally, the study seeks to determine the safety and therapeutic potential of the formulation as an alternative or supportive treatment in pediatric UTIs.
 
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