| CTRI Number |
CTRI/2025/04/084236 [Registered on: 07/04/2025] Trial Registered Prospectively |
| Last Modified On: |
05/04/2025 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Ayurveda |
| Study Design |
Randomized, Parallel Group, Active Controlled Trial |
|
Public Title of Study
|
To Assess The Efficacy Of Shunthyadi Kashay In Management Of Mutrakrucchra With Special Reference To Urinary Tract Infection |
|
Scientific Title of Study
|
Randomised Controlled Clinical Trial To Assess The Efficacy Of Shunthyadi Kashay In Management Of Mutrakrucchra With Special Reference To Urinary Tract Infection |
| Trial Acronym |
no |
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Dr Smita Yogesh Jadhav |
| Designation |
PG Scholar |
| Affiliation |
LRP Ayurvedic Medical College And Hospital PG Institute And Research Centre Urun Islampur |
| Address |
LRP Ayurvedic Medical College And Hospital Post Graduate Institute And Research Centre Islampur Department of Shalyatantra Division No 1 Room No 1 Tal Walwa Dist Sangali
Sangli
MAHARASHTRA
415409
India |
| Phone |
9657601543 |
| Fax |
|
| Email |
drsmityogesh1891@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Amit Ramchandra Shedge |
| Designation |
HOD Proffessor In Shalyatantra Department |
| Affiliation |
LRP Ayurvedic Medical College And Hospital PG Institute And Research Centre Urun Islampur |
| Address |
LRP Ayurvedic Medical College And Hospital Post Graduate Institute And Research Centre Islampur Department of Shalyatantra Division No 1 Room NO 1 Tal Walwa Dist Sangali
Sangli
MAHARASHTRA
415409
India |
| Phone |
8888944733 |
| Fax |
|
| Email |
amit.shedage12@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Dr Smita Yogesh Jadhav |
| Designation |
PG Scholar |
| Affiliation |
LRP Ayurvedic Medical College And Hospital PG Institute And Research Centre Urun Islampur |
| Address |
LRP Ayurvedic Medical College And Hospital Post Graduate Institute And Research Centre IslampurDepartment of Shalyatantra Division No 1 Room NO 1 Tal Walwa Dist Sangali
Sangli
MAHARASHTRA
415409
India |
| Phone |
9657601543 |
| Fax |
|
| Email |
drsmityogesh1891@gmail.com |
|
|
Source of Monetary or Material Support
|
| LRP Ayurvedic Medical College And Hospital PG Institute And Research Centre Urun Islampur Sangli 415409 Maharashtra |
|
|
Primary Sponsor
|
| Name |
Dr Smita Yogesh Jadhav |
| Address |
LRP Ayurvedic Medical College And Hospital Post Graduate Institute And Research Centre Islampur Department of Shalyatantra Division No 1 Room No 1 Tal Walwa
Dist Sangli
MAHARASHTRA
415409 |
| 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 Smita Yogesh Jadhav |
LRP Ayurvedic Medical College And Hospital PG Institute And Research Centre Urun Islampur |
LRP Ayurvedic Medical College And Hospital PG Institute And Research Centre Urun Islampur Department of Shalyatantra Division No 1 Room No 1 Tal Walwa Dist Sangli Maharashtra 415409
Sangli
MAHARASHTRA |
9657601543
drsmityogesh1891@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Institutional Ethics Committee |
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 | Comparator Arm | Drug | Classical | | (1) Medicine Name: pashanbhedadi kashaya, Reference: Bharat Bhaishajya Ratnakar Bhag 3, Route: Oral, Dosage Form: Kwatha/ Kashaya, Dose: 20(ml), Frequency: bd, Bhaishajya Kal: Adhobhakta, Duration: 7 Days, anupAna/sahapAna: Yes(details: -koshna Jal), Additional Information: Bharat Bhaishyajya Ratnakar bhag 3 | | 2 | Intervention Arm | Drug | Classical | | (1) Medicine Name: shunthyadi Kashaya, Reference: Bhavprakash Madhyam Kand37/9-10, Route: Oral, Dosage Form: Kwatha/ Kashaya, Dose: 20(ml), Frequency: bd, Bhaishajya Kal: Adhobhakta, Duration: 7 Days, anupAna/sahapAna: Yes(details: -koshna jal), Additional Information: Bhavprakash madhym khand |
|
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
60.00 Year(s) |
| Gender |
Both |
| Details |
1. Patients having signs and symptoms of mutrakrucchra (sadaha,saruja mutrapravruti)
2.Age group between 18 to 60 years.
3. Patients irrespective of religion, sex and economical status |
|
| ExclusionCriteria |
| Details |
1.Pregnancy And lactation are exclude
2. Patients who having known case of any part of urinary tract , renal failure , chronic kidney diseases, renal calculi , nephritis, pyelonephritius , prostate enlargement .
3. Phimosis or paraphimosis
4. Patients having known case of systemic illness like DM,HTN,,Asthma,HIV,HBSAg.
5. Patients having autoimmune disorders.
6. Patients having fever with other diseases like typhoid, malaria, dengue etc. |
|
|
Method of Generating Random Sequence
|
Computer generated randomization |
|
Method of Concealment
|
Other |
|
Blinding/Masking
|
Open Label |
|
Primary Outcome
|
| Outcome |
TimePoints |
To Study The efficacy Of Shunthyadi Kashay In Management Of Mutrakrucchra
|
Orally For 7Days follow up 10,15 day |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
1. To study mutrakrucchra in detail as per ayurvedic aspect.
2.To study urinary tract infection in detail according to modern aspect |
Orally For 7 Days
|
|
|
Target Sample Size
|
Total Sample Size="80"
Sample Size from India="80"
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)
|
20/04/2025 |
| 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="0"
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
|
This is Randomised Clinical trial Shunthyadi Kashay used in Mutrakrucchra with special reference to urinary tract infection. In this kashay contains Pashanbhed , Varun , Gokshur are shit in virya that cure burning micturition as well as Agnimantha , Shunthi with their Shoolhar Properties, Gokshur mutravirechana properties. Shigru Gambhari has antipyritic and antibactrial action . Yawakshar Saindhav lavan ,Hingu Churna this herbs act on mutravaha strotas which improve urinary flow , reduce burning sensation and pain. Total No. Of Patients taken Trial group 40 and control group 40. |