| CTRI Number |
CTRI/2025/07/090661 [Registered on: 10/07/2025] Trial Registered Prospectively |
| Last Modified On: |
10/07/2025 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Drug
Ayurveda |
| Study Design |
Randomized, Parallel Group Trial |
|
Public Title of Study
|
A Study Comparing the Effects of Yava Paneeya Kshara and Kadali Paneeya Kshara in Treating Urinary Tract Infections (UTI) |
|
Scientific Title of Study
|
A Comparative Clinical Study to Evaluate the Efficacy of Yava Paneeya Kshara and Kadali Paneeya Kshara in the Management of Mutrakrichra Urinary Tract Infection |
| 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 Vishal Shahaji Zanje |
| Designation |
Post Graduate Resident in Shalya Tantra |
| Affiliation |
Dr N A Magadum Ayurvedic Medical college hospital and research center Ankali 591213 |
| Address |
Dr N A Magdum Ayurvedic medical College Hospital and Research Centre Ankali
Belgaum
KARNATAKA
591213
India |
| Phone |
7219195999 |
| Fax |
|
| Email |
vishalzanje999@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Duradundi Gudasi |
| Designation |
Professor and HOD Department of Shalya Tantra |
| Affiliation |
Dr N A Magadum Ayurvedic Medical college hospital and research center Ankali 591213 |
| Address |
Dr N A Magdum Ayurvedic medical College Hospital and Research Centre Ankali
Dr N A Magdum Ayurvedic medical College Hospital and Research Centre Ankali
Belgaum
KARNATAKA
591213
India |
| Phone |
9743192805 |
| Fax |
|
| Email |
duradundi85@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Dr Duradundi Gudasi |
| Designation |
Professor and HOD Department of Shalya Tantra |
| Affiliation |
Dr N A Magdum Ayurvedic medical College Hospital and Research Centre Ankali |
| Address |
Dr N A Magdum Ayurvedic medical College Hospital and Research Centre Ankali
Belgaum
KARNATAKA
591213
India |
| Phone |
9743192805 |
| Fax |
|
| Email |
duradundi85@gmail.com |
|
|
Source of Monetary or Material Support
|
| Dr N A Magdum Ayurvedic medical College Hospital and Research Centre Ankali 591213 Taluk Chikodi Dist Belgaum |
|
|
Primary Sponsor
|
| Name |
Dr Vishal Shahaji Zanje |
| Address |
Dr N A Magdum Ayurvedic medical College Hospital and Research Centre Ankali |
| Type of Sponsor |
Other [Self] |
|
|
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 Vishal Shahaji Zanje |
Dr N A Magdum Ayurvedic medical College Hospital Ankali |
Department of Shalyatantra Room no 4 Belgaum Karnataka
Belgaum
KARNATAKA |
7219195999
vishalzanje999@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Dr.NAMAMAC-IEC |
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: MUTRAKRUCCRAM, |
|
|
Intervention / Comparator Agent
|
| sno | Intervention/Comparator | Type | Drug-Type | Procedure Name | Details | | 1 | Intervention Arm | Drug | Classical | | (1) Medicine Name: Kadali Paneeya kshara, Reference: Sushruta Samhita , Route: Oral, Dosage Form: Kshara , Dose: 500(mg), Frequency: bd, Bhaishajya Kal: Adhobhakta, Duration: 14 Days, anupAna/sahapAna: Yes(details: Water), Additional Information: - | | 2 | Comparator Arm | Drug | Classical | | (1) Medicine Name: Yava Paneeya kshara, Reference: Bhaishajya Ratnavali, Route: Oral, Dosage Form: Kshara , Dose: 500(mg), Frequency: bd, Bhaishajya Kal: , Duration: , anupAna/sahapAna: No, Additional Information: (2) Medicine Name: 14 Days, Reference: , Route: Water , Dosage Form: Kshara , Dose: (), Frequency: , Bhaishajya Kal: , Duration: , anupAna/sahapAna: No, Additional Information: |
|
|
|
Inclusion Criteria
|
| Age From |
20.00 Year(s) |
| Age To |
60.00 Year(s) |
| Gender |
Both |
| Details |
Patients with clinical Features of Mutrakrichra and UTI like
Pain in Lower Abdomen
Fever
Burning Micturation
Heamaturia |
|
| ExclusionCriteria |
| Details |
Contraindicated to Paneeya Kshara
Uncontrolled Diabetes Mellitus and Hypertension
BPH Renal Calculi Vesical Calculi Interstetial Cystitis PID
Pregnant and Lactating Women
|
|
|
Method of Generating Random Sequence
|
Computer generated randomization |
|
Method of Concealment
|
Centralized |
|
Blinding/Masking
|
Open Label |
|
Primary Outcome
|
| Outcome |
TimePoints |
To Reduce Burning and Painful Micturation
To Reduce Frequency of Micturation |
To Reduce Burning and Painful Micturation
To Reduce Frequency of Micturation |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| To Reduce Heamaturia and Pyuria |
45 Days |
|
|
Target Sample Size
|
Total Sample Size="60"
Sample Size from India="60"
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)
|
30/07/2025 |
| Date of Study Completion (India) |
Applicable only for Completed/Terminated trials |
| Date of First Enrollment (Global) |
30/07/2025 |
| Date of Study Completion (Global) |
Applicable only for Completed/Terminated trials |
|
Estimated Duration of Trial
|
Years="1"
Months="2"
Days="0" |
|
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
|
This Clinical Study Compares the Effectiveness of Yava Paneeya Kshara and Kadali Paneeya Kshara in Treating Mutrakrichra urinary tract infection Sixty Patients were Divided into Two Groups and given either of the two Ayurvedic Formulations 500 mg twice daily for 14 days Symptoms like Burning, Painful, and Frequent Urination were Assessed along with Lab Tests The Aim is to find a Safe, Cost Effective Alternative to Antibiotics using Traditional Ayurvedic Remedies |