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CTRI Number  CTRI/2026/02/105057 [Registered on: 27/02/2026] Trial Registered Prospectively
Last Modified On: 21/02/2026
Post Graduate Thesis  Yes 
Type of Trial  Interventional 
Type of Study   Drug
Unani 
Study Design  Randomized, Parallel Group Trial 
Public Title of Study   Effect of Two Traditional Unani Medicines in Women with Urine Leakage During Coughing or Sneezing 
Scientific Title of Study   A Randomized Comparative Clinical Trial of Sufoof e Masik ul Baul and Majoon Kundur in Salas al Bawl Stress Urinary Incontinence 
Trial Acronym  NIL 
Secondary IDs if Any  
Secondary ID  Identifier 
NIL  NIL 
 
Details of Principal Investigator or overall Trial Coordinator (multi-center study)  
Name  Dr Zeba Fathima 
Designation  PG SCHOLAR 
Affiliation  Government Unani Medical College and Hospital  
Address  Room no G11 Department of Ilmul Qabalat wa Amraz e Niswan Government Unani Medical College and Hospital Basaveshwaranagar Bangalore KARNATAKA 560079 India

Bangalore
KARNATAKA
560079
India 
Phone  9448826030  
Fax    
Email  fzebafathima4@gmail.com  
 
Details of Contact Person
Scientific Query
 
Name  Dr Manjula S 
Designation  Principal, Professor and Guide 
Affiliation  Government Unani Medical College and Hospital  
Address  Room no G11 Department of Ilmul Qabalat wa Amraz e Niswan Government Unani Medical College and Hospital Basaveshwaranagar Bangalore KARNATAKA 560079 India

Bangalore
KARNATAKA
560079
India 
Phone  9731628373  
Fax    
Email  drmanjulaprasad@gmail.com  
 
Details of Contact Person
Public Query
 
Name  Dr Manjula S 
Designation  Principal, Professor and Guide 
Affiliation  Government Unani Medical College and Hospital  
Address  Room no G11 Department of Ilmul Qabalat wa Amraz e Niswan Government Unani Medical College and Hospital Basaveshwaranagar Bangalore KARNATAKA 560079 India

Bangalore
KARNATAKA
560079
India 
Phone  9731628373  
Fax    
Email  drmanjulaprasad@gmail.com  
 
Source of Monetary or Material Support  
Government Unani Medical College and Hospital Dr Siddaiah Puranik Road, Basaveshwaranagar, Bangalore 560079, Karnataka, India  
 
Primary Sponsor  
Name  Government Unani Medical College & Hospital Bangalore 560079 
Address  Room no G11 Department of Ilmul Qabalat wa Amraz e Niswan,Government Unani Medical College and Hospital Dr Siddaiah Puranik Road, Basaveshwaranagar, Bangalore 560079, Karnataka, India  
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 Zeba Fathima  Government Unani Medical College and Hospital  Room no G11 Department of Ilmul Qabalat wa Amraz e Niswan,Government Unani Medical College and Hospital Dr Siddaiah Puranik Road, Basaveshwaranagar, Bangalore 560079, Karnataka, India Bangalore, KARNATAKA
Bangalore
KARNATAKA 
9448826030

fzebafathima4@gmail.com 
 
Details of Ethics Committee  
No of Ethics Committees= 1  
Name of Committee  Approval Status 
Institutional Ethics Committee (IEC) for Biomedical Research, Government Unani Medical College and Hospital, Bangalore   Approved 
 
Regulatory Clearance Status from DCGI  
Status 
Not Applicable 
 
Health Condition / Problems Studied  
Health Type  Condition 
Patients  (1) ICD-10 Condition: N393||Stress incontinence (female) (male),  
 
Intervention / Comparator Agent  
Type  Name  Details 
Comparator Agent  Majoon kundur ingredients Juft Baloot One hundred gram Kundur One hundred gram Qust Shireen One hundred gram Filfil Siyah Forty gram Zanjabeel Forty gram Saad Kufi Two hundred ten gram Qiwam Shakar One point eight kilogram  Ingredients will be procured from the market, quality checked and cleaned. Majoon will be prepared and administered orally ten grams in two divided doses daily with water for two months 
Intervention  Safoof masik ul Baul ingredients Baloot Five hundred gram Kundur Three hundred gram Gil e Armani One hundred gram Samagh e Arabi One hundred gram Kishneez Khushk Biryan One hundred gram Mayeen Kalan Fifty gram Gulnar Fifty gram  All ingredients will be procured from the market quality checked and cleaned. The ingredients will be powdered and ten point five grams is administered orally in two divided doses daily with water for two months 
 
Inclusion Criteria  
Age From  20.00 Year(s)
Age To  65.00 Year(s)
Gender  Female 
Details  Female aged twenty to sixty five years
Married parous women
Weak pelvic floor muscles
Diagnosed with Stress Urinary Incontinence based on QUID and ICIQ SF questionnaires 
 
ExclusionCriteria 
Details  Pregnancy and lactation
Diabetes Mellitus
Hepatic and renal insufficiency
Urinary tract infection
Known cases of genitourinary malignancy
Ongoing treatment of Stress Urinary Incontinence 
 
Method of Generating Random Sequence   Computer generated randomization 
Method of Concealment   An Open list of random numbers 
Blinding/Masking   Open Label 
Primary Outcome  
Outcome  TimePoints 
Improvement in QUID and ICIQ SF  Baseline,15th day,30th day,45th day, 60th day, 75th day
 
 
Secondary Outcome  
Outcome  TimePoints 
Improvement in UDI IIQ IQoL and ISI  Baseline and 75th day 
 
Target Sample Size   Total Sample Size="34"
Sample Size from India="34" 
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)   28/09/2026 
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 Yet Recruiting 
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  
Stress Urinary Incontinence is the involuntary leakage of urine during physical exertion such as sneezing coughing laughing walking or turning in bed. Common causes include childbirth trauma menopause obesity multiparity and pelvic surgeries such as hysterectomy.
Globally urinary incontinence affects more than sixty two percent of women with approximately thirty seven point five percent of these cases being Stress Urinary Incontinence. The incidence varies depending on age obesity and menopausal status.
Indian studies report a prevalence of urinary incontinence ranging from twenty five percent to forty five percent with Stress Urinary Incontinence accounting for approximately forty three point seven percent of these cases. However the actual prevalence may be higher due to social stigma and under reporting.
Stress Urinary Incontinence significantly impairs quality of life leading to embarrassment social withdrawal reduced sexual satisfaction anxiety and depression.
In conventional medicine management includes pelvic floor muscle exercises pharmacological agents such as duloxetine intravaginal devices and surgical procedures. However these options may not be suitable for all patients due to cost side effects or invasiveness.
In classical Unani texts urinary incontinence is described under the term Salas al Bawl defined as involuntary loss of urine or inability to control urination.
According to Unani physicians Salas al Bawl is considered a symptom of various diseases. Causes include
Sue Mizaj Barid meaning abnormal cold temperament
Sue Mizaj Haar meaning abnormal warm temperament
Istirkha al Mathana meaning flaccidity of urinary bladder muscles
Khalal Faqrat Mathana meaning damage to supporting structures of urinary bladder
Injury to spinal cord
Despite high prevalence and significant impact there is limited research evaluating effectiveness of Unani medicine in its management. Formulations such as Sufoof e Masik ul Baul and Majoon Kundur are believed to offer cost effective non invasive and holistic alternatives. Therefore scientific validation through clinical research is essential
 
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