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CTRI Number  CTRI/2025/01/078894 [Registered on: 17/01/2025] Trial Registered Prospectively
Last Modified On: 14/12/2024
Post Graduate Thesis  Yes 
Type of Trial  Observational 
Type of Study   Cross Sectional Study 
Study Design  Other 
Public Title of Study   To assess the prognosis of Benign Prostatic Hyperplasia Through Taila Bindu Pariksha  
Scientific Title of Study   An observational study to correlate the findings of Taila bindu Pariksha with TAUS IPSSCORE and PSA levels to assess the prognostic aspects of Benign Prostatic Hyperplasia 
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 Pavneet Kaur 
Designation  PG Scholar 
Affiliation  Shri Dhanwantry Ayurvedic College and hospital Sector 46 B Chandigarh 
Address  A 107 Department of Rog Nidan Evum Vikriti Vigyan Shri Dhanwantry Ayurvedic College and Hospital Sector 46 B Chandigarh 160047

Chandigarh
CHANDIGARH
160047
India 
Phone  7973835947  
Fax    
Email  pavneetk195@gmail.com  
 
Details of Contact Person
Scientific Query  
Name  Dr Nithin Krishnan 
Designation  Associate Professor 
Affiliation  Shri Dhanwantry Ayurvedic College and Hospital sector 46 B Chandigarh 160047 
Address  A 107 Department of Rog Nidan Evum Vikriti Vigyan Shri Dhanwantry Ayurvedic College and Hospital Sector 46 B Chandigarh 160047

Chandigarh
CHANDIGARH
160047
India 
Phone  9620300103  
Fax    
Email  drnithinkrishnan@gmail.com  
 
Details of Contact Person
Public Query  
Name  Dr Pavneet Kaur 
Designation  PG Scholar 
Affiliation  Shri Dhanwantry Ayurvedic College and hospital Sector 46 B Chandigarh 
Address  A 107 Department of Rog Nidan Evum Vikriti Vigyan Shri Dhanwantry Ayurvedic College and Hospital Sector 46 B Chandigarh 160047

Chandigarh
CHANDIGARH
160047
India 
Phone  7973835947  
Fax    
Email  pavneetk195@gmail.com  
 
Source of Monetary or Material Support  
Laboratory of Shri Ayurvedic college and Hospital Sector 46 B Chandigarh 160047 
 
Primary Sponsor  
Name  Dr Pavneet Kaur 
Address  A-107 Department of Rog Nidan Evum Vikriti Vigyan Shri Dhanwantry Ayurvedic College and Hospital Sector 46 B Chandigarh 160047 
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 Pavneet Kaur  Shri Dhanwantry Ayurvedic College and Hospital sector 46 B Chandigarh 160047  A-107 Department of Rog Nidan evum Vikriti Vigyan Shri Dhanwantry Ayurvedic College and Hospital Sector 46 B Chandigarh 160047
Chandigarh
CHANDIGARH 		 7973835947

pavneetk195@gmail.com 
 
Details of Ethics Committee  
No of Ethics Committees= 1  
Name of Committee  Approval Status 
Institutional Ethics Committee Shri Dhanwantry Ayurvedic College and Hospital  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: ASHTHILIKA,  
 
Intervention / Comparator Agent  
snoIntervention/ComparatorTypeDrug-TypeProcedure NameDetails
 
Inclusion Criteria  
Age From  40.00 Year(s)
Age To  85.00 Year(s)
Gender  Male 
Details  Patients who willingly participate and has given written consent.
Diagnosed Patients of Benign Prostatic Hyperplasia of age 40-85 years 
 
ExclusionCriteria 
Details  Patients who are not willing to include themselves into the study
Patients with Prostatitis
Patients with Kidney stones
Patients with Prostate cancer
Patients with Diabetes mellitus 
 
Method of Generating Random Sequence   Other 
Method of Concealment   Other 
Blinding/Masking   Participant and Investigator Blinded 
Primary Outcome  
Outcome  TimePoints 
To correlate Taila bindu Pariksha findings with TAUS Trans Abdominal Ultrasonography IPSS International Prostate
Symptom Score and PSA Prostate Specific Antigen Test levels in Benign Prostatic Hyperplasia Patients
 		 Baseline
 
 
Secondary Outcome  
Outcome  TimePoints 
To study the directions of oil dispersion in Benign Prostatic
Hyperplasia patients through Taila bindu Pariksha
To study the rate of spread of oil drop in Benign Prostatic
Hyperplasia patients through Taila bindu Pariksha
To study the Doshic predominance in subjects of Benign Prostatic Hyperplasia through Taila bindu Pariksha
To see any specific pattern found in the urine of Benign
Prostatic Hyperplasia patient after the Taila bindu Pariksha
To assess the Dasavidha Rogi Pariksha of Benign Prostatic
Hyperplasia patient
 		 Baseline 
 
Target Sample Size   Total Sample Size="250"
Sample Size from India="250" 
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)   01/02/2025 
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  

An observational study to correlate the findings of Taila bindu Pariksha with TAUS, IPSSCORE and PSA levels to assess the prognostic aspects of Benign Prostatic Hyperplasia.

Introduction

Taila Bindu Pariksha, an Ayurvedic diagnostic method, evaluates urine to assess the prognosis, severity, and treatment planning for Benign Prostatic Hyperplasia (BPH). It addresses symptoms like urinary flow restriction and Lower Urinary Tract Symptoms (LUTS). Integrating Ayurvedic urine analysis with modern tools such as TAUS (Trans Abdominal Ultrasonography), IPSS (International Prostate Symptom Score), and PSA (Prostate Specific Antigen) offers insights into BPH management.

Need of Study

BPH, a common condition in aging men, increases morbidity and LUTS, impairing quality of life. While prognosis remains a challenge, Taila Bindu Pariksha offers a cost-effective approach. This study correlates its findings with modern diagnostic tools and revalidates Acharya Yogratnakar’s ancient Ayurvedic method.

Aim and Objectives

Aim: To Assess Taila Bindu Pariksha’s utility in BPH prognosis by correlating it with TAUS, IPSS, and PSA levels.

Primary Objective: TO Correlate Taila Bindu Pariksha results with TAUS, IPSS, and PSA levels.

Secondary Objectives: To Examine oil dispersion patterns, spread rates, Doshic predominance, and Dasavidha Rogi Pariksha in BPH patients.

Material and Methods

An observational study will include 250 patients from IPD and OPD of Shri Dhanwantry Ayurvedic College and Hospital, Chandigarh. Patients meeting diagnostic and inclusion criteria will be screened based on laboratory findings, Transabdominal ultrasonography, and IPSS questionnaires.

Taila Bindu Pariksha involves urine sample collection from BPH patients and recording oil dispersion patterns via videography. Diagnosis is supported by TAUS, PSA, and IPSS scores.

The study employs a double-blind design to ensure unbiased results. Patients are unaware of the purpose of the analysis, and the investigator remains blinded to patient identities. Urine samples are coded by the lab technician, who securely maintains confidentiality. The statistician will analyze the combined dataset, interpret results, and prepare the final report based on integrated data.

For data analysis, two groups will be compared: Group A (BPH patients on medication) and Group B (BPH patients without medication), focusing on correlations between Taila Bindu Pariksha findings and clinical parameters.

Statistical Analysis

Data will be recorded using Case Report Forms (CRFs) integrating Ayurvedic and modern parameters. Descriptive and inferential statistics will be employed, using tools like Z-test, t-test, Spearman’s rank, and Mann-Whitney U test. Analysis will be performed via SPSS, Python, and R, with significance set at p < 0.05.

 
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