跳至主要内容
临床试验/CTRI/2025/01/078894
CTRI/2025/01/078894尚未招募不适用

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

Dr Pavneet Kaur1 个研究点 分布在 1 个国家目标入组 250 人开始时间: 2025年2月1日最近更新:

试验速览

阶段
不适用
状态
尚未招募
发起方
入组人数
250
试验地点
1
主要终点
To correlate Taila bindu Pariksha findings with TAUS Trans Abdominal Ultrasonography IPSS International Prostate

研究概览

简要总结

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.

研究设计

研究类型
Observational

入排标准

年龄范围
40.00 Year(s) 至 85.00 Year(s)(—)
性别
Male

入选标准

  • Patients who willingly participate and has given written consent.
  • Diagnosed Patients of Benign Prostatic Hyperplasia of age 40-85 years.

排除标准

  • 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.

结局指标

主要结局

To correlate Taila bindu Pariksha findings with TAUS Trans Abdominal Ultrasonography IPSS International Prostate

时间窗: Baseline

Symptom Score and PSA Prostate Specific Antigen Test levels in Benign Prostatic Hyperplasia Patients

时间窗: Baseline

次要结局

  • To study the directions of oil dispersion in Benign Prostatic(Hyperplasia patients through Taila bindu Pariksha)

研究者

发起方
Dr Pavneet Kaur
申办方类型
Other [self]
责任方
Principal Investigator
主要研究者

Dr Pavneet Kaur

Shri Dhanwantry Ayurvedic College and hospital Sector 46 B Chandigarh

研究点 (1)

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