To evaluate the efficacy of Unani Compound Formulations in the management of Azm-e-Ghudda-e-Madhi (Benign Prostatic Hyperplasia)
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
DR MOHD NAZIM
Department of Ilmul Jarahat State Takmeel uttib College and Hospital
