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CTRI Number  CTRI/2024/11/077015 [Registered on: 19/11/2024] Trial Registered Prospectively
Last Modified On: 17/11/2024
Post Graduate Thesis  Yes 
Type of Trial  Interventional 
Type of Study   Drug
Ayurveda 
Study Design  Randomized, Parallel Group, Active Controlled Trial 
Public Title of Study   To study the effect of Ervarubeejaadi yog and Renalka syrup in management of Pittaja Mutrakrichha with special reference to Dysuria 
Scientific Title of Study   A Randomized Controlled Clinical Trial to evaluate the efficacy of Ervarubeejaadi yog in Management of pittaja Mutrakriccha 
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 shweta Manohar Zoting 
Designation  Pg Scholar  
Affiliation  PDEAs College of Ayurved and Research Centre,Nigdi,Pune 
Address  PDEAs College of Ayurved and Research Centre,Third floor,Shalyatantra department Sector no.25 Pradhikaran, Nigdi

Pune
MAHARASHTRA
411044
India 
Phone  8412950566  
Fax    
Email  shwetamzoting@gmail.com  
 
Details of Contact Person
Scientific Query  
Name  Dr Bharat K Oza 
Designation  Associate Professor 
Affiliation  PDEAs College of Ayurved and Research Centre,Nigdi,Pune 
Address  PDEAs College of Ayurved and Research Centre,Third floor,Shalyatantra department Sector no.25,Pradhikaran, Nigdi

Pune
MAHARASHTRA
411044
India 
Phone  9970254593  
Fax    
Email  drbharat_oza@yahoo.co.in  
 
Details of Contact Person
Public Query  
Name  Dr Bharat K Oza 
Designation  Associate Professor 
Affiliation  PDEAs College of Ayurved and Research Centre,Nigdi,Pune 
Address  PDEAs College of Ayurved and Research Centre,Third floor,Shalyatantra department Sector no.25,Pradhikaran, Nigdi

Pune
MAHARASHTRA
411044
India 
Phone  9970254593  
Fax    
Email  drbharat_oza@yahoo.co.in  
 
Source of Monetary or Material Support  
PDEAs College of Ayurved and Research Centre,Third floor,Shalyatantra department Sector no.25,Pradhikaran,Nigdi Pune Maharashtra 411044 india 
 
Primary Sponsor  
Name  PDEAs College of Ayurved and Research Centre Nigi Pune 
Address  PDEAs College of Ayurved and Research Centre,Third floor,Shalyatantra department Sector no.25,Nigdi Pradhikaran,Pune 411044 Maharastra ,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 
Dr Shweta Manohar Zoting  Ayurved Rugnalya and Sterling Multi-speciality Hospital, Nigdi Pune  Shalyatantra Department, OPD No 123A Pradhikaran Nigdi Pune
Pune
MAHARASHTRA 		 08412950566

shwetamzoting@gmail.com 
 
Details of Ethics Committee  
No of Ethics Committees= 1  
Name of Committee  Approval Status 
Institutional Ethical Committee  Approved 
 
Regulatory Clearance Status from DCGI  
Status 
Not Applicable 
 
Health Condition / Problems Studied  
Health Type  Condition 
Patients  (1) ICD-10 Condition:N309||Cystitis, unspecified. Ayurveda Condition: MUTRAKRUCCRAM,  
 
Intervention / Comparator Agent  
snoIntervention/ComparatorTypeDrug-TypeProcedure NameDetails
1Comparator ArmDrugOther than Classical(1) Medicine Name: Renalka syrup, Reference: NA, Route: Oral, Dosage Form: Sharkara/ Syrup, Dose: 10(ml), Frequency: bd, Bhaishajya Kal: Abhakta, Duration: 7 Days, anupAna/sahapAna: Yes(details: Water), Additional Information: -
2Intervention ArmDrugClassical(1) Medicine Name: Ervarubeejadi Yog, Reference: Bhaisajya Ratnavali, Route: Oral, Dosage Form: Churna/ Powder, Dose: 5(g), Frequency: bd, Bhaishajya Kal: Adhobhakta, Duration: 7 Days, anupAna/sahapAna: Yes(details: -Tandulodak), Additional Information: -
 
Inclusion Criteria  
Age From  18.00 Year(s)
Age To  60.00 Year(s)
Gender  Both 
Details  Patients will be selected irrespective of gender, religion, occupation, economical status and marital status.
Patient presenting with symptoms of Pittaja Mutrakrichha mentioned in Yogratnakar, chapter Mutrakrichha5 .
1. पीत्तं मूत्र (yellowish urine)
2. सरक्तं मूत्र ( haematuria)
3. सरूजं मूत्र ( Pain during micturition)
4. सदाहं मूत्र (Burning micturition)
5. मुहुर्मुहु मूत्र ( frequency of urination)
Patient presenting with above mentioned 2-3 symptoms of pittaja Mutrakriccha will be taken for study.
Patients with or without UTI (confirmed by presence of Pus cells & crystals in urine routine report) having symptoms of pittaja mutrakriccha would be taken for study.
 
 
ExclusionCriteria 
Details  K/C/O –
BPH, Urethral Stricture, Bladder outlet obstruction
Uncontrolled Diabetes Milletus
pregnancy
Renal failure
• Benign or Malignant tumors of Bladder
 
 
Method of Generating Random Sequence   Coin toss, Lottery, toss of dice, shuffling cards etc 
Method of Concealment   Alternation 
Blinding/Masking   Open Label 
Primary Outcome  
Outcome  TimePoints 
The effect of Ervarubeejaadi yog will be accessed with the effect of Renalka syrup in pittaja mutrakrichha after 7 days .Assessment will be done by criteria like Brning micturition, painful micturition,Haematuria,Frequency of micturition   pt will be followed up on 3rd , 5th then on 7th day & if necessary on 10th day  
 
Secondary Outcome  
Outcome  TimePoints 
NA  NA 
 
Target Sample Size   Total Sample Size="66"
Sample Size from India="66" 
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)   01/12/2024 
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   This study is randomized standard controlled clinical trial to assess the efficacy of Ervarubeejaadi yog in the management of Pittaja Mutrakriccha.In this study we are going to see Ervarubeejaadi yog for Trial group and Renalka syrup for control group which one is doing well in pittaja mutrakriccha. In Ayurveda, the urinary disorders are described in the form of 8 types of Mutrakriccha, 13 types of Mutraghat, 4 types of Ashmari and 20 types of Prameha. Mutrakriccha comes under the disorders of Mutravaha strotas and mainly deals with Shoola(pain) and kriccha(dysuria). In  Mutrakriccha, the vitiated Pitta dosha along with the Vata (Apana vayu) on reaching Basti (Urinary bladder) afflicts the Mutravaha strotas due to which the patient feels difficulty in micturition.
The above mentioned symptomatology has close resemblance with urinary tract infection ( Cystitis).Mutrakriccha can also be seen as an independent disease as well as Purvarupa and Rupa of the other diseases. The common symptoms explained by Yogratnakar are yellowish urine, heamaturia ,burning micturition ,painful micturition, increase in frequency of micturition. 
Renalka syrup has been used in the treatment of Urinary Tract Infection especially for burning micturition . The  study intends  to evaluate efficacy  of Ervarubeejaadi yog . By comparing effects  of both types  of treatment  we can get judgement  of efficacy  of Ervarubeejaadi yog  & Renalka syrup in the management of Pittaja  Mutakriccha .
The trial drug Ervarubeejaadi yog  will be prepared according to the classical text  from sharangdhar samhita . Ervarubeejaadi  yog  is in the churna form  which contains  only  3 drug  ervarubeeja, Yastimadhu & daruharidra. Renalka syrup contains Shatavari , Sariva , Musta & Gokshura.
Study will include total 66 patient  & wiil be divided in to 2 groups 
 Group A ( Trial  group ) - 33 patient will be administrated with Ervarubeejaadi yog  5gm BD with 1 cup tanduloka 
 Group B (control group ) - 33  patient will be administrated  with Renalka syrup 10 ml BD with 1cup of lukewarm water
There has not been any research conducted to access the efficacy of Ervarubeejaadi yog  with Renalka syrup in the management of pittaja mutrakriccha . Therefore , this study will help in the  future  curative strategy of mutrakriccha . Hence, this topic is selected 

 
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