跳至主要内容
临床试验/CTRI/2024/08/072872
CTRI/2024/08/072872尚未招募2 期

To evaluate the efficacy of Unani Compound Formulations in the management of Azm-e-Ghudda-e-Madhi (Benign Prostatic Hyperplasia)

State Takmeel uttib College and Hospital Lucknow1 个研究点 分布在 1 个国家目标入组 30 人开始时间: 2024年9月10日最近更新:

试验速览

阶段
2 期
状态
尚未招募
发起方
入组人数
30
试验地点
1
主要终点
Poor stream of urine

研究概览

简要总结

The primary purpose of the protocol is to outline standardized procedures for diagnosing, managing and treating BPH, a common condition in older men characterized by an enlarged prostate gland.

The protocol aims to provide a clear framework for assessing symptoms, evaluating the severity of the condition, and implementing appropriate interventions to improve patient outcomes and Quality of Life. This may include lifestyle modifications, medications, depending on the severity of the symptoms and the overall health of the patient.

To assess the various clinical presentations of BPH.

BPH is an old-age disease that is nearly never seen in people under the age of fifty. The prevalence of BPH varies with age. In general, the prevalence of BPH in males over the age of 50 varies from 20% to 62% worldwide.

The Quality of Life (QoL) is negatively impacted by Lower Urinary Tract Symptoms (LUTS), which are extremely irritating and interfere with daily routine.

Alternative medicines are risk-free and have the ability to improve both i.e. Quality of Life (QoL) and Lower Urinary Tract Symptoms (LUTS).

One of the most often used treatment option for BPH nowadays is phytotherapy or polyherbal treatment. The classic literature of the Unani System of Medicine has several references to Unani formulations and single drugs for the symptomatic treatment of BPH.

Due to old-age, patient doesn’t want to go under surgical procedure and prefer to medicated treatment. Hence the present study will focus on the management of Azm-e-Ghudda-e-Madhi (Benign Prostatic Hyperplasia) by Unani formulations.

The study aims to assess whether these Unani compound formulations can offer significant benefits in alleviating symptoms, improving urinary function, and enhancing overall Quality of Life for patients with BPH. The hypothesis underlying the study is that Unani compound formulations will demonstrate measurable efficacy in managing BPH symptoms.

研究设计

研究类型
Interventional
分配方式
Na
盲法
None

入排标准

年龄范围
40.00 Year(s) 至 80.00 Year(s)(—)
性别
Male

入选标准

  • Male patients complaining of LUTS Clinically diagnosed patients of BPH PSA level less than 10ng/ml USG findings (weight less than 60gm and PVR less than 200cc) Male patients willing to give written informed consent.

排除标准

  • Patients with severe cardiac and pulmonary diseases Patients with hepatic and renal diseases Uncontrolled Hypertension Uncontrolled Diabetes Mellitus Vesical Calculus Acute retention of urine Neurogenic bladder Abscess and Carcinoma of the prostate PSA level equal or more than 10ng/ml USG findings (weight equal or more than 60gm and PVR equal or more than 200cc) Male patients who not willing to give consent Mentally retarded patients.

结局指标

主要结局

Poor stream of urine

时间窗: 0, 7th, 14th, 21st, 28th, 35th and 42nd day

Hesitancy during micturition

时间窗: 0, 7th, 14th, 21st, 28th, 35th and 42nd day

Terminal dribbling

时间窗: 0, 7th, 14th, 21st, 28th, 35th and 42nd day

Feeling of incomplete emptying of urinary bladder

时间窗: 0, 7th, 14th, 21st, 28th, 35th and 42nd day

Frequency of urine

时间窗: 0, 7th, 14th, 21st, 28th, 35th and 42nd day

Nocturia

时间窗: 0, 7th, 14th, 21st, 28th, 35th and 42nd day

Urgency of urine

时间窗: 0, 7th, 14th, 21st, 28th, 35th and 42nd day

次要结局

  • Prostate Specific Antigen (PSA)(USG (Abdomenopelvic) including Full Bladder Volume (FBV) and Residual Urine Volume (RUV))

研究者

发起方
State Takmeel uttib College and Hospital Lucknow
申办方类型
Government medical college
责任方
Principal Investigator
主要研究者

DR MOHD NAZIM

Department of Ilmul Jarahat State Takmeel uttib College and Hospital

研究点 (1)

Loading locations...

相似试验