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CTRI Number  CTRI/2022/10/046356 [Registered on: 11/10/2022] Trial Registered Prospectively
Last Modified On: 21/09/2022
Post Graduate Thesis  Yes 
Type of Trial  Interventional 
Type of Study   Ayurveda 
Study Design  Single Arm Study 
Public Title of Study   To study the efficacy of Basti procedure along with oral medicine in urine incontinance 
Scientific Title of Study   A clinical study to evaluate the efficacy of Ashwabaladi Taila Uttar Basti along with Brahatiyadi Kashayam orally in Mutratita (Urine incontinance) 
Trial Acronym   
Secondary IDs if Any  
Secondary ID  Identifier 
NIL  NIL 
 
Details of Principal Investigator or overall Trial Coordinator (multi-center study)  
Name  Dr Omprakash Nain 
Designation  PG Scholar 
Affiliation  UPGIAS&R, Dr. Sarvepalli Radhakrishnan Rajasthan Ayurved University, Jodhpur 
Address  PG Department of Shalya, UPGIAS&R, Dr. Sarvepalli Radhakrishnan Rajasthan Ayurved University, Jodhpur

Jodhpur
RAJASTHAN
342037
India 
Phone  8290282168  
Fax    
Email  dromnain29@gmail.com  
 
Details of Contact Person
Scientific Query  
Name  Dr Rajesh Kumar Gupta 
Designation  Head of Department 
Affiliation  UPGIAS&R, Dr. Sarvepalli Radhakrishnan Rajasthan Ayurved University, Jodhpur 
Address  PG Department of Shalya, UPGIAS&R, Dr. Sarvepalli Radhakrishnan Rajasthan Ayurved University, Jodhpur

Jodhpur
RAJASTHAN
342037
India 
Phone  9636520573  
Fax    
Email  guptadrrajeshkumargupta@gmail.com  
 
Details of Contact Person
Public Query  
Name  Dr Rajesh Kumar Gupta 
Designation  Head of Department 
Affiliation  UPGIAS&R, Dr. Sarvepalli Radhakrishnan Rajasthan Ayurved University, Jodhpur 
Address  PG Department of Shalya, UPGIAS&R, Dr. Sarvepalli Radhakrishnan Rajasthan Ayurved University, Jodhpur

Jodhpur
RAJASTHAN
342037
India 
Phone  9636520573  
Fax    
Email  guptadrrajeshkumargupta@gmail.com  
 
Source of Monetary or Material Support  
UPGIAS&R Dr Sarvepalli Radhakrishnan Rajasthan Ayurved University, Jodhpur 
 
Primary Sponsor  
Name  UPGIASR Dsrrau jodhpur 
Address  Dr Sarvepalli Radhakrishnan Rajasthan Ayurved University, Jodhpur  
Type of Sponsor  Government 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 Omprakash Nain  Hospital of UPGIAS&R  Room No. 14, OPD Shalya, Hospital of UPGIAS&R Dr Sarvepalli Radhakrishnan Rajasthan Ayurved University, Jodhpur
Jodhpur
RAJASTHAN 		 8290282168

dromnain29@gmail.com 
 
Details of Ethics Committee  
No of Ethics Committees= 1  
Name of Committee  Approval Status 
Institutional Ethics Committee, DSRRAU, Jodhpur  Approved 
 
Regulatory Clearance Status from DCGI  
Status 
Not Applicable 
 
Health Condition / Problems Studied  
Health Type  Condition 
Patients  (1) ICD-10 Condition:N394||Other specified urinary incontinence. Ayurveda Condition: MUTRATITAH,  
 
Intervention / Comparator Agent  
snoIntervention/ComparatorTypeDrug-TypeProcedure NameDetails
1Intervention ArmProcedure-uttara-bastiH, उत्तर-बस्तिः (Procedure Reference: Sushruta Samhita chikitsa sthana 37, Procedure details: Uttar Basti procedure of Ashwabaladi Taila is given to diagnosed patients of Urine Incontinance along with medicine till 6 months. )
(1) Medicine Name: Brihatiyadi Kashayam, Reference: Ashtanga Hridaya chapter 35 shloka 11, Route: Oral, Dosage Form: Kwatha/Kashaya, Dose: 10(ml), Frequency: bd, Duration: 6 Months
 
Inclusion Criteria  
Age From  40.00 Year(s)
Age To  60.00 Year(s)
Gender  Both 
Details  Patients with classical signs and symptoms of urine incontinence will be included in the trial.  
 
ExclusionCriteria 
Details  Patients suffering from disease like UTI, Prostate enlargement cystocele vaginal prolapse. Patiens related with malignancy. 
 
Method of Generating Random Sequence   Computer generated randomization 
Method of Concealment   An Open list of random numbers 
Blinding/Masking   Not Applicable 
Primary Outcome  
Outcome  TimePoints 
Relief from the signs and symptoms of patients after the procedure.
1. Incontinence of
urine
2. Assessment of
urgency (ability
to hold the urine

 		 participate will be assessed before the treatment and 15 days later after the 3rd dose of uttar basti procedure. 
 
Secondary Outcome  
Outcome  TimePoints 
Efficacy of procedure in urine incontinence   6 months 
 
Target Sample Size   Total Sample Size="30"
Sample Size from India="30" 
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)   01/11/2022 
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="0"
Months="6"
Days="0" 
Recruitment Status of Trial (Global)   Not Yet Recruiting 
Recruitment Status of Trial (India)  Not Yet Recruiting 
Publication Details   NIL 
Individual Participant Data (IPD) Sharing Statement

Will individual participant data (IPD) be shared publicly (including data dictionaries)?  

Response - NO
Brief Summary   Patient who are diagnosed with urine incontinence will be selected in opd of department of shalya hospital of upgias&r and will be assessed according to inclusion and exclusion criteria of the trial and will be applied with the procedure of uttar basti of ashwabaladi taila and brahatiyadi kashayam  will be given orally 10 ml twice a day. Results will be assessed on relief in the signs and symptoms of patients. Trial duration will be of 6 months. 
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