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CTRI Number  CTRI/2024/02/062766 [Registered on: 16/02/2024] Trial Registered Prospectively
Last Modified On: 12/02/2024
Post Graduate Thesis  Yes 
Type of Trial  Interventional 
Type of Study   Ayurveda 
Study Design  Randomized, Parallel Group, Active Controlled Trial 
Public Title of Study   The study compares how well uthara basti works in treating Bening Prostatic Hyperplasia when dhanwantharam taila mezhu paka is given through feeding tube (into the bladder) or through folleys adapter (into the urethra). 
Scientific Title of Study   Efficacy of Uá¹­taravasá¹­i with Dhānwaná¹­aram á¹­ailam using Foley’s adapter against using Feeding tube in VāṭāṣtÄ«la with special reference to Benign Prostatic Hyperplasia – A Randomised Controlled Non-Inferiority Trial 
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 Sanal Kumar M P 
Designation  PG Scholar  
Affiliation  VPSV Ayurveda College, kottakkal 
Address  Department of Panchakarma, VPSV Ayurveda College, Kottakkal, Malappuram

Malappuram
KERALA
676501
India 
Phone  9446445787  
Fax    
Email  drsanalkumarmp@gmail.com  
 
Details of Contact Person
Scientific Query  
Name  Dr Jigeesh P P 
Designation  Professor & Head 
Affiliation  VPSV Ayurveda College, kottakkal 
Address  Department of Panchakarma, VPSV Ayurveda College, Kottakkal, Malappuram

Malappuram
KERALA
676501
India 
Phone  9447997436  
Fax    
Email  drjigeesh@gmail.com  
 
Details of Contact Person
Public Query  
Name  Dr Jigeesh P P 
Designation  Professor & Head 
Affiliation  VPSV Ayurveda College, kottakkal 
Address  Department of Panchakarma, VPSV Ayurveda College, Kottakkal, Malappuram

Malappuram
KERALA
676501
India 
Phone  9447997436  
Fax    
Email  drjigeesh@gmail.com  
 
Source of Monetary or Material Support  
Arya vaidya sala kottakkal GMP certified institute 
 
Primary Sponsor  
Name  VPSV Ayurveda College Kottakkal 
Address  VPSV Ayurveda College, Kottakkal, Malappuram, Kerala 676501 
Type of Sponsor  Other [Aided 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 SANAL KUMAR M P  VPSV Ayurveda College, Kottakkal  OPD Department of Panchakarma,Room No A112 VPSV Ayurveda College, Kottakkal 676501
Malappuram
KERALA 		 9446445787

drsanalkumarmp@gmail.com 
 
Details of Ethics Committee  
No of Ethics Committees= 1  
Name of Committee  Approval Status 
Institutional Ethics Committee [IEC] Vaidyaratnam P S Varier Ayurveda College Kottakkal  Approved 
 
Regulatory Clearance Status from DCGI  
Status 
Not Applicable 
 
Health Condition / Problems Studied  
Health Type  Condition 
Patients  (1) ICD-10 Condition:N401||Benign prostatic hyperplasia withlower urinary tract symptoms. Ayurveda Condition: VATASHTHILA,  
 
Intervention / Comparator Agent  
snoIntervention/ComparatorTypeDrug-TypeProcedure NameDetails
1Intervention ArmProcedure-uttara-bastiH, उत्तर-बस्तिः (Procedure Reference: Google. (2009, April 17). KR100893667B1 - liquid injector into the male urethra. Google Patents, Procedure details: Sterile foley’s adapter is obtained either by autoclave (metal) or by using a fresh disposable piece(plastic). Then drug is administrated through the urethra by inserting the adapter through the urethra until it seals the urethra so as to prevent the back flow of the medicine while pushing. Maximum penetrating length will be 4-5 cm. Then 30 ml of Dhānwanṭaram ṭailam will be loaded into a 50 ml syringe & it will be connected to adapter then push the medicine gently into the urethra))
(1) Medicine Name: Dhanwantharam tailam Mezhupakam, Reference: Prof.K.R Srikantha Murthy.editor.Vagbhata Ashtangahrudaya with sarvangasundara & Ayurvedarasayana commentary, Krishnadas ayurveda series vol.27.varanasi: Chaukhamba Sanskrit Sansthan;2016. Sharira Sthana 2/47-52, Route: Urethral, Dosage Form: Taila, Dose: 30(ml), Frequency: od, Duration: 7 Days
2Comparator ArmProcedure-uttara-bastiH, उत्तर-बस्तिः (Procedure Reference: Akhil C Suresh.A randomized clinical study to compare the effectiveness of dhanwantara taila as uttara basti and oral administration in the management of vatashtheela with special reference to benign prostate hyperplasia [dissertation].All India Institute of Ayurveda; 2022, Procedure details: Sterile feeding tube is selected after the calibration procedure of urethra. Tube will be then inserted carefully into the bladder via the urethra. After accessing the bladder drug will be administrated through the tube by using a 50 ml sterile syringe. Feeding tube will be carefully removed & penis will be clamped using a catheter clamp in order to prevent the leakage of medicine. The participant will be asked to lie in supine position until he feels urge to evacuate the bladder ))
(1) Medicine Name: Dhanwantharam Tailam Mezhupakam, Reference: Prof.K.R Srikantha Murthy.editor.Vagbhata Ashtangahrudaya with sarvangasundara & Ayurvedarasayana commentary, Krishnadas ayurveda series vol.27.varanasi: Chaukhamba Sanskrit Sansthan;2016. Sharira Sthana 2/47-52, Route: Urethral, Dosage Form: Taila, Dose: 30(ml), Frequency: od, Duration: 7 Days
 
Inclusion Criteria  
Age From  50.00 Year(s)
Age To  70.00 Year(s)
Gender  Male 
Details  Age between 50 and 70
Prostate volume below 70 cc in USG
PSA below 4 ng/ml
IPSS between 8 and 19
Post Void Residual Urine Volume greater than or equal to 50
 
 
ExclusionCriteria 
Details  Those who are Uá¹­taravasá¹­i anarha.
Diagnosed cases of Malignancy.
Sexually Transmitted Diseases (STD).
Participants having other Urinary system. pathologies like severe Urinary tract infection, Nephrolithiasis, Urethral stricture, Prostatitis and Congenital deformity of Urogenital system.
Uncontrolled Diabetes Mellitus, Hypertension, Hypercholesterolemia.
Participants having other systemic pathologies where Uá¹­taravasá¹­i is difficult to administer. 
 
Method of Generating Random Sequence   Computer generated randomization 
Method of Concealment   Sequentially numbered, sealed, opaque envelopes 
Blinding/Masking   Not Applicable 
Primary Outcome  
Outcome  TimePoints 
Change in self-administered IPSS questionnaire score  15th and 45th day from the starting of procedure 
 
Secondary Outcome  
Outcome  TimePoints 
Reduction in Prostate size &
Post void Residual Urine Volume. Samyak laká¹£ana of Uá¹­taravasá¹­i also be noted
 		 Prostate size & Post void residual urine volume will be assessed on 0th & 45th days. Event Evaluation Scale & Samyak laká¹£ana chart will be observed on every day of Uthara vasthi 
 
Target Sample Size   Total Sample Size="24"
Sample Size from India="24" 
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)   22/02/2024 
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="6"
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 aim of this study is to compare the effectiveness of Uá¹­taravasá¹­i with Dhānwaná¹­aram á¹­ailam administered through Foley’s adapter or feeding tube in treating VāṭāṣtÄ«la wsr Benign Prostatic Hyperplasia. This is a randomized controlled open label non-inferiority trial. 24 patients will be recruited from the OPD of VPSV Ayurveda College, Kottakkal using consecutive sampling and assigned to either group by a computer program. The intervention group will receive Uthara vasti with 30ml medicine through Foley’s adapter, while the control group will receive the same through feeding tube. The treatment will be given on alternate days for 14 days. The patients will be followed up for 30 days. Assessment will be done by IPSS score and USG. 
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