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CTRI Number  CTRI/2024/08/072872 [Registered on: 22/08/2024] Trial Registered Prospectively
Last Modified On: 12/08/2024
Post Graduate Thesis  Yes 
Type of Trial  Interventional 
Type of Study   Drug
Unani 
Study Design  Single Arm Study 
Public Title of Study   A study to evaluate efficacy of Unani Compound Formulations in Benign Prostatic Hyperplasia 
Scientific Title of Study   To evaluate the efficacy of Unani Compound Formulations in the management of Azm-e-Ghudda-e-Madhi (Benign Prostatic Hyperplasia) 
Trial Acronym  BPH 
Secondary IDs if Any  
Secondary ID  Identifier 
NIL  NIL 
 
Details of Principal Investigator or overall Trial Coordinator (multi-center study)  
Name  DR MOHD NAZIM 
Designation  PG Scholar 
Affiliation  Department of Ilmul Jarahat State Takmeel uttib College and Hospital 
Address  Department of Ilmul Jarahat State Takmeel uttib College and Hospital Near Ramabai Rally Sthal Bijnor Road Auranagabad Tiraha

Lucknow
UTTAR PRADESH
226002
India 
Phone  9675395928  
Fax    
Email  nazimamu6@gmail.com  
 
Details of Contact Person
Scientific Query  
Name  Dr Safiya Lokhande 
Designation  Professor and HoD 
Affiliation  Department of Ain Uzn Anaf wa Halaq State Takmeel uttib College and Hospital 
Address  Department of Ain Uzn Anaf wa Halaq State Takmeel uttib College and Hospital Near Ramabai Rally Sthal Bijnor Road Aurangabad Tiraha

Lucknow
UTTAR PRADESH
226002
India 
Phone  7985186938  
Fax    
Email  drsafiyalokhande@gmail.com  
 
Details of Contact Person
Public Query  
Name  Dr Abdul Quavi 
Designation  Professor and HoD 
Affiliation  Department of Ilmul Jarahat State Takmeel uttib College and Hospital 
Address  Department of Ilmul Jarahat State Takmeel uttib College and Hospital Near Ramabai Rally Sthal Bijnor Road Aurangabad Tiraha
Near Ramabai Rally Sthal Bijnor Road Aurangabad Tiraha
Lucknow
UTTAR PRADESH
226002
India 
Phone  9455077880  
Fax    
Email  quavinium@gmail.com  
 
Source of Monetary or Material Support  
State Takmeel uttib College and Hospital Lucknow Near Ramabai Rally Sthal Bijnor Road Auranagabad Tiraha 226002 
 
Primary Sponsor  
Name  State Takmeel uttib College and Hospital Lucknow 
Address  Near Ramabai Rally Sthal Bijnor Road Auranagabad Tiraha 226002 
Type of Sponsor  Government medical college 
 
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 MOHD NAZIM  State Takmeel uttib College and Hospital  Department of Ilmul Jarahat State Takmeel uttib College and Hospital Near Ramabai Rally Sthal Bijnor Road Auranagabad Tiraha 226002
Lucknow
UTTAR PRADESH 		 9675395928

nazimamu6@gmail.com 
 
Details of Ethics Committee  
No of Ethics Committees= 1  
Name of Committee  Approval Status 
Institutional Ethics Committee State Takmeel uttib College and Hospital Lucknow  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,  
 
Intervention / Comparator Agent  
Type  Name  Details 
Comparator Agent  NIL  NIL 
Intervention  Prepared Unani Formulation include the following ingredients: Shorah Qalmi (Potassium Nitrate) 1gm, Jawakhar (Hordium vulgare) 1gm and Namak-e-Turb (Raphanus sativus) 1gm.  1 tsf safoof for 6 weeks orally BD. 
Intervention  Prepared Unani Formulation include the following ingredients: Shorah Qalmi (Potassium Nitrate) 3gm, Tukhm-e-Neel (Ipomoea nil) 12gm and Kafoor (Cinnamomum camphora) 3gm.  Topical Application for 6 weeks OD. 
Intervention  Sharbat-e-Bazoori 20ml.  Orally for 6 weeks BD. 
 
Inclusion Criteria  
Age From  40.00 Year(s)
Age To  80.00 Year(s)
Gender  Male 
Details  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 
 
ExclusionCriteria 
Details  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 
 
Method of Generating Random Sequence   Not Applicable 
Method of Concealment   Not Applicable 
Blinding/Masking   Not Applicable 
Primary Outcome  
Outcome  TimePoints 
Poor stream of urine
Hesitancy during micturition
Terminal dribbling
Feeling of incomplete emptying of urinary bladder
Frequency of urine
Nocturia
Urgency of urine 		 0, 7th, 14th, 21st, 28th, 35th and 42nd day 
 
Secondary Outcome  
Outcome  TimePoints 
Prostate Specific Antigen (PSA)
USG (Abdomenopelvic) including Full Bladder Volume (FBV) and Residual Urine Volume (RUV) 		 0 and 42nd day 
 
Target Sample Size   Total Sample Size="30"
Sample Size from India="30" 
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   Phase 2 
Date of First Enrollment (India)   10/09/2024 
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="6"
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  
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.
 
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