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Clinical Trials/CTRI/2024/08/072872
CTRI/2024/08/072872Not yet recruitingPhase 2

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 site in 1 country30 target enrollmentStarted: September 10, 2024Last updated:

Trial Snapshot

Phase
Phase 2
Status
Not yet recruiting
Sponsor
Enrollment
30
Locations
1
Primary Endpoint
Poor stream of urine

Study Overview

Brief Summary

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.

Study Design

Study Type
Interventional
Allocation
Na
Masking
None

Eligibility Criteria

Ages
40.00 Year(s) to 80.00 Year(s) (—)
Sex
Male

Inclusion Criteria

  • 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.

Exclusion Criteria

  • 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.

Outcomes

Primary Outcomes

Poor stream of urine

Time Frame: 0, 7th, 14th, 21st, 28th, 35th and 42nd day

Hesitancy during micturition

Time Frame: 0, 7th, 14th, 21st, 28th, 35th and 42nd day

Terminal dribbling

Time Frame: 0, 7th, 14th, 21st, 28th, 35th and 42nd day

Feeling of incomplete emptying of urinary bladder

Time Frame: 0, 7th, 14th, 21st, 28th, 35th and 42nd day

Frequency of urine

Time Frame: 0, 7th, 14th, 21st, 28th, 35th and 42nd day

Nocturia

Time Frame: 0, 7th, 14th, 21st, 28th, 35th and 42nd day

Urgency of urine

Time Frame: 0, 7th, 14th, 21st, 28th, 35th and 42nd day

Secondary Outcomes

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

Investigators

Sponsor
State Takmeel uttib College and Hospital Lucknow
Sponsor Class
Government medical college
Responsible Party
Principal Investigator
Principal Investigator

DR MOHD NAZIM

Department of Ilmul Jarahat State Takmeel uttib College and Hospital

Study Sites (1)

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