| CTRI Number |
CTRI/2025/06/088276 [Registered on: 04/06/2025] Trial Registered Prospectively |
| Last Modified On: |
27/05/2025 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Ayurveda |
| Study Design |
Randomized, Parallel Group, Active Controlled Trial |
|
Public Title of Study
|
Evaluating The Efficacy Of Vidaryadi Kwath for Managing Pittaj Mutrakrucchra A Clinical Trial On Urinary Tract Infection. |
|
Scientific Title of Study
|
Randomized Controlled Clinical Trial To Study The Effect Of Vidaryadi Kwath In The Management Of Pittaj Mutrakrucchra 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 Kamlesh Shivaji Mahajan |
| Designation |
MD Scholar |
| Affiliation |
Department Of kayachikitsa Shree Saptshrungi Ayurved Mahavidyalaya And Hospital Nashik |
| Address |
OPD No.2, Department Of Kayachikitsa, Shree Saptshrungi Ayurved Mahavidyalaya And Hospital, Kamal Nagar, Hirawadi, Panchvati, Nashik,422003 Maharashtra,
India
Nashik
MAHARASHTRA
422003
India |
| Phone |
8857903851 |
| Fax |
|
| Email |
mahajankamlesh41@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Somdatta Bhaskarrao Kulkarni |
| Designation |
HOD |
| Affiliation |
Department Of kayachikitsa Shree Saptshrungi Ayurved Mahavidyalaya And Hospital Nashik |
| Address |
OPD No. 2,Departmant of kayachikitsa, Shree Saptshrungi Ayurved Mahavidyalaya And Hospital, Kamal Nagar, Hirawadi, Panchvati, Nashik,422003 Maharashtra, India
Nashik
MAHARASHTRA
422003
India |
| Phone |
9860268117 |
| Fax |
|
| Email |
somdattak85@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Dr Kamlesh Shivaji Mahajan |
| Designation |
MD Scholar |
| Affiliation |
Department Of kayachikitsa Shree Saptshrungi Ayurved Mahavidyalaya And Hospital Nashik |
| Address |
OPD No. 2, Department Of Kayachikitsa, Shree Saptshrungi Ayurved Mahavidyalaya And Hospital, Kamal Nagar, Hirawadi, Panchvati, Nashik, Maharashtra 422003 India
Nashik
MAHARASHTRA
422003
India |
| Phone |
8857903851 |
| Fax |
|
| Email |
mahajankamlesh41@gmail.com |
|
|
Source of Monetary or Material Support
|
| Shree Saptshrungi Ayurved Medical college And Hospital, Kamal nagar, Hirawadi, Panchvati, Nashik 422003, Maharashtra India |
|
|
Primary Sponsor
|
| Name |
Shree Saptshrungi Ayurved Mahavidyala Kamalnagar Hirawadi Panchvati Nashik |
| Address |
Department Of Kayachikitsa, Shree Saptshrungi Ayurved, Kamalnagar, Hirawadi, Panchvati, Nashik 422003,Maharashtra, India |
| Type of Sponsor |
Private medical college |
|
|
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 Kamlesh Shivaji Mahajan |
Shree Saptshrungi Ayurved Medical College and Hospital |
Department of Kayachikitsa Shree Saptshrungi Ayurved Mahavidyalaya and Hospital ,Kamal Nagar ,Hirawadi,Panchavati,Nashik ,Maharashtra
Nashik
MAHARASHTRA |
8857903851
mahajankamlesh41@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| IEC Shree Saptshrungi Ayurved Mahavidyalaya Nashik |
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: Vidaryadi Kwath, Reference: Bhaishajya Ratnavali, Chapter no. 34,Shlock no. 18, Route: Oral, Dosage Form: Kwatha/ Kashaya, Dose: 48(ml), Frequency: bd, Bhaishajya Kal: Pragbhakta, Duration: 7 Days, anupAna/sahapAna: Yes(details: -Madhu), Additional Information: - | | 2 | Comparator Arm (Non Ayurveda) | | - | Disodium Hydrogen Citrate | Syp.Disodium Hydrogen Citrate 20 ml Tds after food(Breakfast, Lunch, Dinner) orally with water for 7 days. |
|
|
|
Inclusion Criteria
|
| Age From |
20.00 Year(s) |
| Age To |
60.00 Year(s) |
| Gender |
Both |
| Details |
1.Patients having signs and symptomps of Pittaj Mutrakrucchra.
2.Patients irrespective of religion,sex,economical status.
3.Patients with uncomplicated urinary tract infection. |
|
| ExclusionCriteria |
| Details |
1.Pregnancy and Lactation.
2.Prostate enlargement.
3.Known case of malignancy.
4.Phimosis or Paraphimosis
5.Known case of renal failure,chronic kidney disease,urinary calculas.
6.Traumatic causes.
7.Known case of uncontrolled Diabetes. |
|
|
Method of Generating Random Sequence
|
Computer generated randomization |
|
Method of Concealment
|
Not Applicable |
|
Blinding/Masking
|
Open Label |
|
Primary Outcome
|
| Outcome |
TimePoints |
| Reduction in signs and symptomps of urinary tract infection. |
7th day |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| Where the Trial group stands in comparison with Control group in reducing signs and symptoms of Urinary Tract Infection. |
18 Months |
|
|
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)
|
09/06/2025 |
| 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="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
|
Primary Objective: 1. To study the effect of Vidaryadi Kwath in the management of Pittaj Mutrakrucchra with special reference to urinary tract infection.
Secondary Objective: 1. To study the disease Pittaj Mutrakrucchra In detail according to ayurved. 2. To study urinary tract infection in detail.
Participants: 60 adults diagnosed with Pittaj Mutrakrucchra, meeting inclusion and exclusion criteria from Opd and Ipd of department of Kayachikitsa,Shree Saptshrungi Ayurved Mahavidyalaya and Hospital, Nashik.
Treatment duration:90 days
Follow up: 5th day, 7th day
Data Analysis:Data will be analysed using appropriate stastical methods to compare the effectivness of the intervention on the primary and secondary outcomes.
Ethical consideration: The study will be conducted in accordance with ethical guidelines and with informed consent from participants. |