| CTRI Number |
CTRI/2025/12/099633 [Registered on: 22/12/2025] Trial Registered Prospectively |
| Last Modified On: |
20/12/2025 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Drug
Ayurveda |
| Study Design |
Single Arm Study |
|
Public Title of Study
|
A study to see how well the Ayurvedic Medicine Yawadi Kwath works in the treatment of Urinary Tract Infection |
|
Scientific Title of Study
|
Single Arm Clinical Study To Assess The Effect Of Yawadi Kwath In Pittaj Mutrakruchhra With Special Reference To 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 Sushilkumar Shivajirao Jadhav |
| Designation |
PG Scholar |
| Affiliation |
LRP Ayurvedic Medical College And Hospital PG Institute And Research Center Urun Islampur Sangli |
| Address |
OPD No 1 Kayachikitsa Department LRP Ayurvedic Medical College
And Hospital PG Institute and Research Center Urun Islampur
Sangli
MAHARASHTRA
415409
India
Sangli
MAHARASHTRA
415409
India |
| Phone |
9284475464 |
| Fax |
|
| Email |
sushil.sj27@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Anant Ghare |
| Designation |
Associate Professor |
| Affiliation |
LRP Ayurvedic Medical College And Hospital PG Institute And Research Center Urun Islampur Sangli |
| Address |
OPD No 1 Kayachikitsa Department LRP Ayurvedic Medical College
And Hospital PG Institute and Research Center Urun Islampur
Sangli
MAHARASHTRA
415409
India
Sangli
MAHARASHTRA
415409
India |
| Phone |
9503555535 |
| Fax |
|
| Email |
dr.anant53@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Dr Anant Ghare |
| Designation |
Associate Professor |
| Affiliation |
LRP Ayurvedic Medical College And Hospital PG Institute And Research Center Urun Islampur Sangli |
| Address |
OPD No 1 Kayachikitsa Department LRP Ayurvedic Medical College
And Hospital PG Institute and Research Center Urun Islampur
Sangli
MAHARASHTRA
415409
India
Sangli
MAHARASHTRA
415409
India |
| Phone |
9503555535 |
| Fax |
|
| Email |
dr.anant53@gmail.com |
|
|
Source of Monetary or Material Support
|
| Loknete Rajarambapu Patil Ayurvedic Medical College And Hospital PG Institute and Research Center Urun Islampur Sangli |
|
|
Primary Sponsor
|
| Name |
Dr Sushilkumar Shivajirao Jadhav |
| Address |
OPD No 1 Kayachikitsa Department LRP Ayurvedic Medical College And Hospital PG Institute And Research Center Urun Islampur Sangli |
| 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 Sushilkumar Shivajirao Jadhav |
LRP Ayurvedic Medical College And Hospital PG Institute And Research Center Urun Islampur 415409 |
OPD No 1 Kayachikitsa Department Urun Islampur Sangli MAHARASHTRA
Sangli
MAHARASHTRA |
9284475464
sushil.sj27@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Institutional Ethical Committee LRP Ayurvedic Medical College and Hospital and PCT and RC Approved |
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: Yawadi Kwath, Reference: Yogratnakara, Route: Oral, Dosage Form: Kwatha/ Kashaya, Dose: 20(ml), Frequency: bd, Bhaishajya Kal: Adhobhakta, Duration: 15 Days, anupAna/sahapAna: Yes(details: -koshna jal), Additional Information: - | | 2 | Intervention Arm | Procedure | - | Kwatha,क्वाथ | (Procedure Reference: Sharangdhar Samhita madhyam khand, Procedure details: Take 1 part of bharad churna with 16 parts of water i.e 10gm bharad churna in 160ml of water in an open vessel
Boil it on mild flame till it reduces to 1/8th of original quantity i.e 20ml
Filter the prepared kwath and take it orally)
(1) Medicine Name: Yawadi Kwath, Reference: Yogratnakara, Route: Oral, Dosage Form: Kwatha/Kashaya, Dose: 20(ml), Frequency: bd, Duration: 15 Days |
|
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
60.00 Year(s) |
| Gender |
Both |
| Details |
1.Patients presenting with cardinal symptoms of Pittaj Mutrakruchhra mentioned in
Samhitas as,
a) Sapeeta Mutrapravrutti
b) Sarakt Mutrapravrutti
c) Muhurmuhu Mutra pravrutti
d) Sadaha Mutrapravrutti
e) Sashul Mutrapravrutti
2. Urine pus cells and Epithelial Cells range 5-20 / hpf
3. RBCs in urine range 5-20 / hpf |
|
| ExclusionCriteria |
| Details |
1. Known case of Chronic Kidney Diseases.
2. Patients with known case of any Systemic Disease or Urinary Calculi.
3. Patient with surgical history of any part of Urinary Tract.
4. Womens which are in Antenatal care(ANC) and Postnatal care (PNC) state |
|
|
Method of Generating Random Sequence
|
Other |
|
Method of Concealment
|
Other |
|
Blinding/Masking
|
Open Label |
|
Primary Outcome
|
| Outcome |
TimePoints |
| Yawadi Kwath is effective in management of Pittaj Mutrakruchhra |
Initial assessment at 0 day
Follow up at 7th day
Final assessment at 15th day |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
Improvement of Daha(burning)
Shoola(pain) Peeta varna mutra(yellowish urine) scores |
Initial assessment at 0 day
Follow up at 7th day
Final assessment at 15th day |
|
|
Target Sample Size
|
Total Sample Size="70"
Sample Size from India="70"
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)
|
12/01/2026 |
| 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
|
Mutrakruchhra is one of the common disorder of mutravaha strotas.Mutrakruchhra is a self explanatory name that derives from the words mutra and kruchhra.The root of the term mutra is prasrava which meaning to ooze.The word kruchhra derived from kashte which means to cause trouble or anguish.Pittaj Mutrakruchhra is a type of mutrakruchhra(dysuria) described in Ayurveda, where aggravated pitta dosha affects the mutravaha strotas(urinary system),often due to an imbalanced diet, lifestyle factors and the suppression of the urge to urinate.In Pittaj Mutrakruchhra symptoms like yellowish, with blood, painful,with burning sensation,with difficulty and frequent micturition are seen.Urinary tract infection are the second most infection in community practice.Most of people suffering from this condition and used to take modern medicine, which are quick in action but may have some side effects.Also there is problem of developing resistance to such type of drugs due to their repeated use.Hence this subject was selected for the present clinical study.The study will include total 70 eligible patients,aged from 18-60 years with clinically diagnosed pittaj mutrakruchhra/urinary tract infection from our institute Kayachikitsa department.Participant will receive 15 days treatment course combining the holistic principles of Ayurvedic medicines.The treatment regimen includes Yawadi Kwath an orally administered Ayurvedic formulation.This will provide robust evaluation of the treatment, efficacy and it’s impact on patients quality of life. |