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CTRI Number  CTRI/2023/01/048678 [Registered on: 02/01/2023] Trial Registered Prospectively
Last Modified On: 29/12/2022
Post Graduate Thesis  Yes 
Type of Trial  Interventional 
Type of Study   Drug
Ayurveda
Other (Specify) 
Study Design  Randomized, Parallel Group Trial 
Public Title of Study   A randomised open labelled double arm clinical study of uttarvasti with varunadi tailam and dhanwantri tailam in vatasthila w,s.r. to benign prostate hyperplasia 
Scientific Title of Study   A randomised open labelled double arm clinical study of uttarvasti with varunadi tailam and dhanwantri tailam in vatasthila w,s.r. to benign prostate hyperplasia 
Trial Acronym   
Secondary IDs if Any  
Secondary ID  Identifier 
NIL  NIL 
 
Details of Principal Investigator or overall Trial Coordinator (multi-center study)  
Name  Dr Rohit Kumar 
Designation  PG scholar 
Affiliation  Sri Jayendra Saraswathi Ayurveda College & Hospital,  
Address  Sri Jayendra Saraswathi Ayurveda College and Hospital Chennai 600123
Sri Jayendra Saraswathi Ayurveda College and Hospital Chennai 600123
Chennai
TAMIL NADU
600123
India 
Phone  8218310910  
Fax    
Email  rohitdr2008@gmail.com  
 
Details of Contact Person
Scientific Query  
Name  Dr T Udayakiran 
Designation  Professor 
Affiliation  jayendra saraswathi ayurveda college and hospital  
Address  Sri Jayendra Saraswathi Ayurveda College and Hospital Chennai 600123
Sri Jayendra Saraswathi Ayurveda College and Hospital Chennai 600123
Chennai
TAMIL NADU
600123
India 
Phone  9849666054  
Fax    
Email  dr_tenneti@yahoo.co.in  
 
Details of Contact Person
Public Query  
Name  Dr T Udayakiran 
Designation  Professor 
Affiliation  jayendra saraswathi ayurveda college and hospital  
Address  Sri Jayendra Saraswathi Ayurveda College and Hospital Chennai 600123
Sri Jayendra Saraswathi Ayurveda College and Hospital Chennai 600123
Chennai
TAMIL NADU
600123
India 
Phone  9849666054  
Fax    
Email  dr_tenneti@yahoo.co.in  
 
Source of Monetary or Material Support  
Sri Jayendra Saraswathi Ayurveda college and hospital 
 
Primary Sponsor  
Name  Dr Rohit kumar  
Address  Department of shalya tantra Room no. 8 OPD block Sri Jayendra Saraswathi Ayurveda College & Hospital, Chennai 600123 
Type of Sponsor  Other [self] 
 
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 Rohit Kumar   sri jayendra saraswathi ayurveda college and hospital   Department of shalya tantra Room no 8 OPD block Sri Jayendra Saraswathi Ayurveda College & Hospital, Chennai 600123
Chennai
TAMIL NADU 		 8218310910

rohitdr2008@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:N400||Benign prostatic hyperplasia without lower urinary tract symptoms. Ayurveda Condition: VATASHTHILA,  
 
Intervention / Comparator Agent  
snoIntervention/ComparatorTypeDrug-TypeProcedure NameDetails
1Intervention ArmProcedure-uttara-bastiH, उत्तर-बस्तिः (Procedure Reference: Charak samhita. siddhisthan. 9/65-67, Procedure details: the patient will be kept in supine position for uttarbasti. Rubber catheter smeared with lignocaine 2% jelly and slowly inserted into urethera. Catheter passed without obstruction, then the bastinetra inserted in the urethera. compressing the bastiputak without shaking it and without causing discomfort. Three uttarvasti will be given. This treatment will be done with a gradual increase in the doses. By the same procedure as same explained above, the process will be repeated with the interval of )
(1) Medicine Name: varunadi tailam and dhanwantara tailam, Reference: bhaijjayay Ratanawali vol 2 chapter no 36 andShasstrayogam tail prakaram page no 74, Route: Urethral, Dosage Form: Taila, Dose: 30(ml), Frequency: od, Duration: 3 Weeks
 
Inclusion Criteria  
Age From  50.00 Year(s)
Age To  70.00 Year(s)
Gender  Male 
Details  1. Patient diagnosed with post voidable urine volume less than 100ml .
2. Patient willing for uttarvasti procedure.
3. Having symptoms of BPH.
4. Patient diagnosed as BPH by both clinical sign symptoms and USG were included.  
 
ExclusionCriteria 
Details  1. Urethral stricture
2. Raised PSA.
3. K/C/O Malignancy of Urogenital System.
4. K/C/O Congenital deformities of Urogenital Tract .
5. K/C/O Renal failure , Uretric calculi , renal calculi , chronic UTI.
6. Uncontrol Diabetes mellitus
7. Hypertension
8. Cardiac problem
9. Liver disease .

 
 
Method of Generating Random Sequence   Not Applicable 
Method of Concealment   Not Applicable 
Blinding/Masking   Open Label 
Primary Outcome  
Outcome  TimePoints 
change in the scoring of incomplete emptying , frequency , Intermittency , urgency , weak stream , Straining , Nocturia symptoms reduce after giving Uttarvasti
2. Complete reduction of the BPH Size .  		 21 days 
 
Secondary Outcome  
Outcome  TimePoints 
1. Any general improvement of in other aspects of health.
2. lack of Recurrence  		 2 month  
 
Target Sample Size   Total Sample Size="40"
Sample Size from India="40" 
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)   07/01/2023 
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="2"
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   The study is an open labelled  double arm clinical study of uttarvasti with varunadi tailam and dhanwantra tailam in Vatasthila w.s.r to Benign Prostrate Hyperplasia. Thus 40 patient fullfilling the inclusion criteria will be selected from the OPD of sri jayendra Saraswathi Ayurveda college and hospital . The primary outcome of the study is to analyse the change in the scoring of Incomplete emptying , Frequency , Intermittency , Urgency , Weak stream, Straining , Nocturia  after the procedure of Uttarvasti for a period of 3 days countinuosly and 4 day gap similarly procedure will be done for 21 days . The secondry outcome of the study fossuses on any general improvement in mental , physical , social aspects of health as well as to note whether there is any recurrence for a period of 2 month . follow up is carried out once a week for one month after 21 days of observation of procedure .  
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