| CTRI Number |
CTRI/2024/12/078155 [Registered on: 16/12/2024] Trial Registered Prospectively |
| Last Modified On: |
21/02/2026 |
| 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 on the Effectiveness of Comparing Yashtyadi Kwath and Yashtyadi Kwath with Coconut Water in Treating Urinary Tract Infections |
|
Scientific Title of Study
|
Clinical Comparative Study to Evaluate the Efficacy of
Yashtyadi Kwath and Yashtyadi Kwath with Narikel Jal Anupan
in the Management of Pittaj Mutrakruccha 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 Amol Ashok Bhuite |
| Designation |
M.S. Scholar Shalyatantra Samanya Department |
| Affiliation |
Shree Saptashrungi Ayurved Mahavidyalaya,Kamal nagar Hiravadi, Panchavati, Nashik, |
| Address |
Department of Shalyatantra Samanya, Shree Saptashrungi Ayurved Mahavidyalaya,Kamal nagar Hiravadi, Panchavati, Nashik, Maharashtra 422003
Nashik
MAHARASHTRA
422003
India |
| Phone |
9773299369 |
| Fax |
|
| Email |
bhuiteamol7679@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Aparna Raut |
| Designation |
H.O.D. |
| Affiliation |
Shree Saptashrungi Ayurved Mahavidyalaya,Kamal nagar Hiravadi, Panchavati, Nashik |
| Address |
Department of Shalyatantra Samanya, Shree Saptashrungi Ayurved Mahavidyalaya,Kamal nagar Hiravadi, Panchavati, Nashik, Maharashtra 422003
Nashik
MAHARASHTRA
422003
India |
| Phone |
9822979769 |
| Fax |
|
| Email |
dr.aparnaraut12@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Dr Amol Ashok Bhuite |
| Designation |
M.S. Scholar Shalyatantra Samanya Department |
| Affiliation |
Shree Saptashrungi Ayurved Mahavidyalaya,Kamal nagar Hiravadi, Panchavati, Nashik |
| Address |
Department of Shalyatantra Samanya, Shree Saptashrungi Ayurved Mahavidyalaya,Kamal nagar Hiravadi, Panchavati, Nashik, Maharashtra 420003
Nashik
MAHARASHTRA
422003
India |
| Phone |
09773299369 |
| Fax |
|
| Email |
bhuiteamol7679@gmail.com |
|
|
Source of Monetary or Material Support
|
| Shree Saptashrungi Ayurved Medical College And Hospital , KamalNagar , Hirawadi , Panchwati, Nashik , MAHARASHTRA , INDIA 422003 |
|
|
Primary Sponsor
|
| Name |
Shree Saptashrungi Ayurved MahavidyalayaKamal nagar Hiravadi Panchavati Nashik |
| Address |
Department of Shalyatantra Samanya, Shree Saptashrungi Ayurved Mahavidyalaya,Kamal nagar Hiravadi, Panchavati, Nashik, Maharashtra 422003 , 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 AMOL ASHOK BHUITE |
Shree Saptashrungi Ayurved Medical College And Hospital |
OPD No.2 Department of Shalyatantatra
Nashik
MAHARASHTRA |
9773299369
bhuiteamol7679@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| IEC Shree Saptashrungi 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: Yashtyadi Kwath , Reference: Bharat bhaishajya ratnavali chaturth bhag, Route: Oral, Dosage Form: Kwatha/ Kashaya, Dose: 24(ml), Frequency: bd, Bhaishajya Kal: Adhobhakta, Duration: 7 Days, anupAna/sahapAna: Yes(details: Narikel Jal), Additional Information: - | | 2 | Comparator Arm | Drug | Classical | | (1) Medicine Name: Yashtyadi Kwath, Reference: Bharat bhaishajya ratnakar chaturth bhag, Route: Oral, Dosage Form: Kwatha/ Kashaya, Dose: 24(ml), Frequency: bd, Bhaishajya Kal: Adhobhakta, Duration: 7 Days, anupAna/sahapAna: No, Additional Information: - |
|
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
60.00 Year(s) |
| Gender |
Both |
| Details |
1. Patients having sign and symptoms of Pittaj Mutrakruchra (Sadaha, Sapeet,
Saruja Mutrapravruti).
2. The age group between 18 to 60 years.
3. Patients irrespective of religion, sex and economical status.
4. Patients with urinary tract infection.
5. Patients having recurrent UTI. |
|
| ExclusionCriteria |
| Details |
1. Pregnancy & lactation
2. Prostate enlargement
3. Patients who having Malignancy of any part of urinary tract.
4. Phimosis or paraphimosis
5. Patients who having Renal failure, chronic kidney diseases, Renal calculus.
6. Sever Traumatic causes
7. Patients who having DM, HTN, Asthma, HIV, HbsAg..
8. Bleeding during micturition due to renal calculus .
9. Patients who having autoimmune disorder. |
|
|
Method of Generating Random Sequence
|
Other |
|
Method of Concealment
|
Other |
|
Blinding/Masking
|
Open Label |
|
Primary Outcome
|
| Outcome |
TimePoints |
| Reduce The Sign And Symptoms Of Pittaj Mutrakruccha |
7 Days |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| No Reccurency Of Pittaj Mutrakruccha |
14 Days |
|
|
Target Sample Size
|
Total Sample Size="70"
Sample Size from India="70"
Final Enrollment numbers achieved (Total)= "70"
Final Enrollment numbers achieved (India)="70" |
|
Phase of Trial
|
Phase 2/ Phase 3 |
|
Date of First Enrollment (India)
|
24/12/2024 |
| Date of Study Completion (India) |
10/10/2025 |
| Date of First Enrollment (Global) |
Date Missing |
| Date of Study Completion (Global) |
Date Missing |
|
Estimated Duration of Trial
|
Years="1"
Months="0"
Days="0" |
|
Recruitment Status of Trial (Global)
|
Not Yet Recruiting |
| Recruitment Status of Trial (India) |
Completed |
Publication Details
Modification(s)
|
N/A |
|
Individual Participant Data (IPD) Sharing Statement
|
Will individual participant data (IPD) be shared publicly (including data dictionaries)?
Response - NO
|
Brief Summary
Modification(s)
|
OBJECTIVES Primary Objective: 1. To compare the efficacy of Yashtyadi kwatha and Yashtyadi kwatha with anupan narikel jal in Pittaj Mutrakrucchra with special reference to urinary tract infection. 2. To study the efficacy of Yashtyadi kwath in Pittaj Mutrakruchhra 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. 3. Study the efficacy of Yashtyadi kwatha in Pittaj mutrakruchchra with special reference to UTI 4. Study the efficacy of Yashtyadi kwath with anupan narikel jal in Pittaj Mutrakrucchra with special reference to urinary tract infection .
PARTICIPANTS 70 Adults diagnosed with urinary tract infection meeting inclusion and exclusion criteria from OPD and IPD of department of shalyatantra of Shree Saptashrungi Medical College and Hospital Nashik
Interventions 35 patients Yashtyadi Kwath : Administered according to standardized protocol. 35 patients Yashtyadi Kwath with Narikel Jal anupan : Administered according to standardized protocol.
Primary Outcome : Reduce the sign and symptoms of pittaj mutrakruccha
Secondary Outcome: No recurrency of pittaj mutrakruccha
Treatment Duration : 7 Days Follow Up :0th , 7th , 14th Days
Data Analysis : Data will be analysed using appropriate statistical methods to compare the effectiveness of the intervension on the primary and secondary outcomes.
Ethical Considerations : The study will be conducted in accordence with ethical guidelines and with informed consent from participents. |