| 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
|
|
|
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
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition:N390||Urinary tract infection, site notspecified. Ayurveda Condition: PITTAJAMUTRAKRUCCRAM, |
|
|
Intervention / Comparator Agent
|
| sno | Intervention/Comparator | Type | Drug-Type | Procedure Name | Details | | 1 | Intervention Arm | Drug | Classical | | (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. |