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CTRI Number  CTRI/2024/02/062595 [Registered on: 13/02/2024] Trial Registered Prospectively
Last Modified On: 25/01/2024
Post Graduate Thesis  Yes 
Type of Trial  Interventional 
Type of Study   Drug
Ayurveda 
Study Design  Non-randomized, Active Controlled Trial 
Public Title of Study   A clinical study to compare the effect of two drugs - patala kshara in tilataila and trikantakadi guggulu in patients with Benign Prostatic Hyperplasia. 
Scientific Title of Study   Effect of Patala kshara with tilataila and Trikantakadi guggulu in reduction of lower urinary tract symptoms secondary to Benign Prostatic Hyperplasia - A Comparative clinical 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 Subi N H 
Designation  Associate Professor 
Affiliation  Government Ayurveda College, Tripunithura 
Address  Department of Shalyatantra Government Ayurveda College Tripunithura Ernakulam -682301

Ernakulam
KERALA
682301
India 
Phone  9495881390  
Fax    
Email  drsubironish@gmail.com  
 
Details of Contact Person
Scientific Query  
Name  Dr. T. Sreekumar 
Designation  Professor 
Affiliation  PNNM Ayurveda Medical College, Shornur 
Address  Department of Shalyatantra PNNM Ayurveda Medical College Shornur
Harisree, Rose Nagar Bypass Junction Mannuthy PO Thrissur - 680651
Thrissur
KERALA
679531
India 
Phone  09447071367  
Fax    
Email  harisree.ayur@yahoo.co.in  
 
Details of Contact Person
Public Query  
Name  Dr Subi N H 
Designation  Associate Professor 
Affiliation  Government Ayurveda College, Tripunithura 
Address  Department of Shalyatantra Government Ayurveda College Tripunithura Ernakulam -682301

Ernakulam
KERALA
682301
India 
Phone  9495881390  
Fax    
Email  drsubironish@gmail.com  
 
Source of Monetary or Material Support  
Government Ayurveda College, Tripunithura, Ernakulam 
 
Primary Sponsor  
Name  Dr Subi N H 
Address  Associate Professor Government Ayurveda College, Tripunithura Ernakulam - 682301 
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 Subi N H  Government Ayurveda College, Tripunithura  Shalyatantra Department, OPD No.4, Ground floor, Hospital building
Ernakulam
KERALA 		 9495881390

drsubironish@gmail.com 
 
Details of Ethics Committee  
No of Ethics Committees= 1  
Name of Committee  Approval Status 
Institutional Committee For Ethics in Research , Govt. Ayurveda College, Tripunithura   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
1Comparator ArmDrugClassical(1) Medicine Name: Trikantakadi guggulu, Reference: Yogaratnakara, Route: Oral, Dosage Form: Guggulu , Dose: 500(mg), Frequency: bd, Bhaishajya Kal: Adhobhakta, Duration: 60 Days, anupAna/sahapAna: Yes(details: Luke warm water), Additional Information:
2Intervention ArmDrugClassical(1) Medicine Name: Patala kshara, Reference: Susruta Samhita, Route: Oral, Dosage Form: Kshara , Dose: 500(mg), Frequency: bd, Bhaishajya Kal: Adhobhakta, Duration: 60 Days, anupAna/sahapAna: Yes(details: -tila taila 5ml), Additional Information: -
 
Inclusion Criteria  
Age From  50.00 Year(s)
Age To  75.00 Year(s)
Gender  Male 
Details  •Patients with LUTS secondary to BPH and diagnosed by Transabdominal Ultrasound.
•BPH with IPSS score minimum 5.
•Patients who are willing to provide written informed consent
 
 
ExclusionCriteria 
Details  •Known cases of Prostatitis, Carcinoma Prostate and those who have undergone any surgery for Prostate.
•Known cases with complications of BPH like acute urinary retention, haematuria, hydronephrosis and renal insufficiency.
•Known cases of stricture of urethra, congenital contracture of bladder neck and bladder polyps and diverticula.
•BPH patients with severe cardiac disease, uncontrolled diabetes mellitus and immuno-compromised.
•Those who are contraindicated for the internal use of kshara.
 
 
Method of Generating Random Sequence   Not Applicable 
Method of Concealment   Not Applicable 
Blinding/Masking   Open Label 
Primary Outcome  
Outcome  TimePoints 
Primary outcome– International Prostate Symptom Score (IPSS) and QOL will be assessed using
validated questionnaire to quantify the reduction in LUTS . 		 At baseline, 31st day and 61st day. 
 
Secondary Outcome  
Outcome  TimePoints 
Change in Post-Void Residual urine volume (PVR) & Prostate Volume (PV) will be assessed using Transabdominal Ultrasound.  At baseline & after 60 days 
 
Target Sample Size   Total Sample Size="70"
Sample Size from India="70" 
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 3 
Date of First Enrollment (India)   13/02/2024 
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="2"
Months="0"
Days="0" 
Recruitment Status of Trial (Global)   Not Yet Recruiting 
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 - YES
  1. What data in particular will be shared?
    Response (Others) -  final trial result

  2. What additional supporting information will be shared?
    Response -  Study Protocol
    Response - Clinical Study Report

  3. Who will be able to view these files?
    Response - Anyone

  4. For what types of analyses will this data be available?
    Response - To achieve aims in the approved proposal.

  5. By what mechanism will data be made available?
    Response (Others) -  on published journal

  6. For how long will this data be available start date provided 01-06-2026 and end date provided 31-12-2031?
    Response - Immediately following publication. No end date.

  7. Any URL or additional information regarding plan/policy for sharing IPD? 
    Additional Information - Nil
Brief Summary   This study is a non randomized active controlled trial comparing the effectiveness of Patala kshara 500mg along with tilataila 5ml twice daily and Trikantakadi guggulu two 500mg tablets twice daily for 60 days in 70 patients with Benign Prostatic Hyperplasia, that will be conducted at Govt. Ayurveda College Hospital, Tripunithura, Ernakulam, Kerala, India. The primary outcome measures will be International Prostate Symptom Score and Quality of  Life, assessed on baseline, 31 and 61 days.  The secondary outcomes will be Post-residual Urine Volume and Prostate Volume assessed by Transabdominal Ultrasound on baseline and after treatment.   
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