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CTRI Number  CTRI/2024/11/076942 [Registered on: 18/11/2024] Trial Registered Prospectively
Last Modified On: 15/11/2024
Post Graduate Thesis  Yes 
Type of Trial  Interventional 
Type of Study   Drug
Ayurveda 
Study Design  Randomized, Parallel Group Trial 
Public Title of Study   Usefullness of ayurvedic Yastyadi kadha in burning sensation of urine 
Scientific Title of Study   Randomised Controlled Clinical Trial to study the efficacy of Yastyadi kwatha in the management of Pittaj Mutrakruccha.  
Trial Acronym  NIL 
Secondary IDs if Any  
Secondary ID  Identifier 
NIL  NIL 
 
Details of Principal Investigator or overall Trial Coordinator (multi-center study)  
Name  Vd Ashvini Ganeshrao Patil 
Designation  Pg Scholar 
Affiliation  Bhartiya Sanskriti Darshan Trusts Ayurved Mahavidyalaya 
Address  Department of Kayachikitsa ,Bhartiya sanskriti Darshan Trusts Ayurved Mahavidyalaya,Vishwashanti Dham Kesanand Road, Wagholi,Pune-412207 Maharashtra

Pune
MAHARASHTRA
412207
India 
Phone  8928088546  
Fax    
Email  drashwinipatil32@gmail.com  
 
Details of Contact Person
Scientific Query  
Name  Vd Anjali Aniruddha Deshpande 
Designation  Professor and HOD of Kayachikitsa 
Affiliation  Bhartiya Sanskriti Darshan Trusts Ayurved Mahavidyalaya wagholi pune maharashtra 412207 
Address  Department of Kayachikitsa Bhartiya Sanskriti Darshan Trusts Ayurved Mahavidyalaya Vishwashanti Dham Kesanand road Wagholi Pune-412207 Maharashtra India
Department of Kayachikitsa Bhartiya Sanskriti Darshan Trusts Ayurved Mahavidyalaya Vishwashanti Dham Kesanand road Wagholi Pune-412207 Maharashtra India
Pune
MAHARASHTRA
412207
India 
Phone  9730069747  
Fax    
Email  anjalidesh1610@gmail.com  
 
Details of Contact Person
Public Query  
Name  Vd Anjali Aniruddha Deshpande 
Designation  Professor and HOD of Kayachikitsa 
Affiliation  Bhartiya Sanskriti Darshan Trusts Ayurved Mahavidyalaya wagholi pune maharashtra 412207 
Address  Department of kayachikitsa OPD Number 1 Bhartiya Sanskriti Darshan Trusts Ayurved Mahavidyalaya Vishwashanti Dham Kesanand road Wagholi Pune-412207 Maharashtra India
Department of kayachikitsa OPD Number 1 Bhartiya Sanskriti Darshan Trusts Ayurved Mahavidyalaya Vishwashanti Dham Kesanand road Wagholi Pune-412207 Maharashtra India
Pune
MAHARASHTRA
412207
India 
Phone  9730069747  
Fax    
Email  anjalidesh1610@gmail.com  
 
Source of Monetary or Material Support  
Bhartiya Sanskriti Darshan Trusts Ayurved Mahavidyalaya Vishawashanti dham kesanand road Wagholi Pune 412207 Maharashtra India  
 
Primary Sponsor  
Name  Bhartiya Sanskriti Darshan Trusts Ayurved Mahavidyalaya Wagholi Pune Maharashtra India  
Address  Bhartiya Sanskriti Darshan Trusts Ayurved Mahavidyalaya Vishwashanti dham Kesanand road Wagholi Pune 412207 Maharashtra India  
Type of Sponsor  Private medical college 
 
Details of Secondary Sponsor  
Name  Address 
NIL  NIL 
 
Countries of Recruitment     India  
Sites of Study  
No of Sites = 1  
Name of Principal Investigator  Name of Site  Site Address  Phone/Fax/Email 
Vd Ashvini Ganeshrao Patil  Bharatiya Sanskriti Darshan Trust Ayurved Hospital Wagholi Pune   Department of Kayachikitsa OPD and IPD of Bharatiya Sanskriti Darshan Trusts Ayurved Mahavidyalaya Vishwashanti dham Kesanand road Wagholi Pune Maharashtra
Pune
MAHARASHTRA 		 8928088546

drashwinipatil32@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  
Status 
Not Applicable 
 
Health Condition / Problems Studied  
Health Type  Condition 
Patients  (1) ICD-10 Condition:N390||Urinary tract infection, site notspecified. Ayurveda Condition: MUTRAKRUCCRAM,  
 
Intervention / Comparator Agent  
snoIntervention/ComparatorTypeDrug-TypeProcedure NameDetails
1Intervention ArmDrugClassical(1) Medicine Name: Yastyadi kwatha, Reference: Sartha rasa ratnakar, Route: Oral, Dosage Form: Kwatha/ Kashaya, Dose: 40(ml), Frequency: bd, Bhaishajya Kal: Abhakta, Duration: 14 Days, anupAna/sahapAna: Yes(details: -Honey,candy sugar,rasasindur bhasma), Additional Information: -
2Comparator ArmDrugClassical(1) Medicine Name: Trunapanchamula kwatha, Reference: Chakradatta, Route: Oral, Dosage Form: Kwatha/ Kashaya, Dose: 40(ml), Frequency: bd, Bhaishajya Kal: Abhakta, Duration: 14 Days, anupAna/sahapAna: No, Additional Information: -
 
Inclusion Criteria  
Age From  20.00 Year(s)
Age To  60.00 Year(s)
Gender  Both 
Details  1)Patients having symptoms -Sadaha mutra,Sashoola mutra,Peeta mutra,Sarakta mutra,Muhurmuhur mutra.
2)Pateints having at least 3-4 above symptoms.
3)Patients of any gender
4)Patients between age group 20 to 60 years 
 
ExclusionCriteria 
Details  1)Patients suffering from Diabetes mellitus.
2)Malignancy of any part of urinary tract.
3)Pregnant and lactating women.
4)Prostate enlargement.
5)Known case of renal failure,chronic kidney disease,ranal calculi.
6)Tuberculosis with undergoing treatment.
7)severe traumatic cases. 
 
Method of Generating Random Sequence   Coin toss, Lottery, toss of dice, shuffling cards etc 
Method of Concealment   Sequentially numbered, sealed, opaque envelopes 
Blinding/Masking   Open Label 
Primary Outcome  
Outcome  TimePoints 
To observe and document the efficacy of Yastyadi Kwatha in the management of Pittaj Mutrakruccha  assessment on 0th 7th 14th day 
 
Secondary Outcome  
Outcome  TimePoints 
To find out adverse effect of Yastyadi kwatha if any  assessment on 0th 7th 14th day 
 
Target Sample Size   Total Sample Size="64"
Sample Size from India="64" 
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   N/A 
Date of First Enrollment (India)   27/11/2024 
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  

The current study is randomized control clinical trial to study the efficacy of  Yastyadi kwatha in the management  of Pittaj Mutrakruccha. Diagnosed patients of Pittaj Mutrakruccha will be divided in two equal groups, Experimental and Control group. The treatment for experimental group is Yastyadi kwath ((decoction) 40 ml with Honey, Sita (candy sugar) and Rasasindura bhasma twice a day for 14 days and Trunapanchamula kwath 4o ml twice a day for 14 days for control group will be given.  Assessment will be done on 0th ,7th ,14th day.

In the modern era, there are many newly arising and old prominent bacterial and viral infections. Among all Urinary tract infection is one of the most common bacterial infections. The prevalence rate of urinary tract infection in India range is 33.54% and affecting 150 million people each worldwide. In the modern medicine urinary tract infection are treated with antimicrobial agents, alkalizing agents and Antibiotics which has many side effects.

Burning, frequent, painful micturition, blood in urine, urinary hesitancy are he symptoms of urinary tract infection that can be corelated with symptoms of Pittaj Mutrakruccha. Ayurved recommends shaman (Internal treatment) and shodhan chikitsa (detoxification treatment) for the treatment of Pittaj Mutrakruccha. Yastyadi kwatha mentioned in Ayurvedic text(Sartha rasa Ratnakar) for the treatment of Pittaj  Mutrakruccha  having  Pitta shamak, mutra virechana, daha prashamana propertieswhich relieving  the Pittaj mutrakruccha selected for the current study which is easily available and cost effective.  

 
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