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CTRI Number  CTRI/2025/03/082716 [Registered on: 19/03/2025] Trial Registered Prospectively
Last Modified On: 18/03/2025
Post Graduate Thesis  Yes 
Type of Trial  Interventional 
Type of Study   Drug
Unani
Other (Specify) 
Study Design  Randomized, Parallel Group, Placebo Controlled Trial 
Public Title of Study   Therapeutic Evaluation of Unani Formulation in Salas al-Bawl (Stress Urinary Incontinence): A Randomized Controlled Study. 
Scientific Title of Study   Therapeutic Evaluation of Unani Formulation in Salas al-Bawl (Stress Urinary Incontinence): A Randomized Controlled Study. 
Trial Acronym  NIL 
Secondary IDs if Any  
Secondary ID  Identifier 
drjuveriya@gmail.com  Other 
 
Details of Principal Investigator or overall Trial Coordinator (multi-center study)  
Name  Dr Juveriya Naaz Bhusnur 
Designation  Assisstant Professor 
Affiliation   
Address  Luqman unani medical colllege hospital and research centre bijapur

Bijapur
KARNATAKA
586101
India 
Phone  7406810517  
Fax    
Email  drjuveriya10@gmail.com  
 
Details of Contact Person
Scientific Query
 
Name  Dr Juveriya Naaz Bhusnur 
Designation  Assisstant Professor 
Affiliation   
Address  Luqman unani medical colllege hospital and research centre bijapur


KARNATAKA
586101
India 
Phone  7406810517  
Fax    
Email  drjuveriya10@gmail.com  
 
Details of Contact Person
Public Query
 
Name  Dr Juveriya Naaz Bhusnur 
Designation  Assisstant Professor 
Affiliation   
Address  Luqman unani medical colllege hospital and research centre bijapur


KARNATAKA
586101
India 
Phone  7406810517  
Fax    
Email  drjuveriya10@gmail.com  
 
Source of Monetary or Material Support  
luqman college 
 
Primary Sponsor  
Name  shahila nigar 
Address  luqman unani medical college and hospital 
Type of Sponsor  Private 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 
shahila nigar  Dr. Shahila Nigar  luqman unani medical colllege hospital and research centre bijapur
Bijapur
KARNATAKA 
9523687616

nigarshahila9081@gmail.com 
 
Details of Ethics Committee  
No of Ethics Committees= 1  
Name of Committee  Approval Status 
Communication of Decision of the Institutional Committee(IEC) for Bio Medical Research  Approved 
 
Regulatory Clearance Status from DCGI  
Status 
Not Applicable 
 
Health Condition / Problems Studied  
Health Type  Condition 
Patients  (1) ICD-10 Condition: N319||Neuromuscular dysfunction of bladder, unspecified, (2) ICD-10 Condition: N319||Neuromuscular dysfunction of bladder, unspecified, (3) ICD-10 Condition: N319||Neuromuscular dysfunction of bladder, unspecified,  
 
Intervention / Comparator Agent  
Type  Name  Details 
Comparator Agent  placebo (roasted floor)   Roasted floor is taken and tablet (each of 1gm) will be made. 
Intervention  Polyherbal Unani formulation  •Kunjud siya(sesamum indicum) •Nankhawa (Trachyspermum Ammi) •Qand siya (Saccharum Officinarum) Above medicines are taken in equal quantity will be powdered and tablet (each of 1gm) will be made.  
 
Inclusion Criteria  
Age From  21.00 Year(s)
Age To  60.00 Year(s)
Gender  Female 
Details  •Married women above the age group of 21-60 years.
•Clinically diagnosed patients of stress urinary incontinence willing to participate in the study.
 
 
ExclusionCriteria 
Details  •Pregnant and lactating women.
•Patients with 3rd and 4th degree genital prolapse.
•H/o systemic illnesses, endocrinal diseases and malignancies.
•H/o any pharmacological intervention within 3 months and have had surgical intervention for SUI.
 
 
Method of Generating Random Sequence   Computer generated randomization 
Method of Concealment   Pre-numbered or coded identical Containers 
Blinding/Masking   Participant and Investigator Blinded 
Primary Outcome  
Outcome  TimePoints 
• Reduction in the number of incontinent episodes assessed by bladder diary.
• Reduction in ICIQ-SF score. 
Baseline (0day), 15th day, 30th day, 45th day and 60th day 
 
Secondary Outcome  
Outcome  TimePoints 
•Pelvic floor muscle strength assessed by Modified Oxford Grading Scale  Baseline (0day), 15th day, 30th day, 45th day and 60th day 
 
Target Sample Size   Total Sample Size="40"
Sample Size from India="40" 
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)   15/04/2025 
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="3" 
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  

Urinary incontinence (UI) is a multifactorial syndrome defined as an involuntary loss of urine[1]. Stress urinary incontinence (SUI) is an age-old problem that continues to generate great interest due to its considerable public health burden and the controversies that surround its management. It has been defined by the International Continence Society (ICS) as ‘‘the involuntary leakage of urine on exertion, or sneezing., urinary incontinence (UI) is an under-reported, undiagnosed, and often untreated medical condition that highly impacts the quality of life for women at any age[2,3]. SUI is one of the most common types of pelvic floor disorders in women.

The reported prevalence of SUI varies widely, ranging from 4.8 to 67% according to different epidemiological report. The symptoms of incontinence can severely compromise the physical, psychological, and economic well-being of individuals and their families, ultimately reducing the quality of life. Despite the high prevalence, health-seeking behaviour regarding SUI is low worldwide only 13–55 % of women with SUI symptoms seek medical care[4]. The risk factors for SUI in women are weak collagen, diabetes mellitus, advanced age, chronic obstructive airway disease, ethnicity, constipation, pregnancy and childbirth, obesity, (body mass index>30), advanced pelvic organ prolapse, hysterectomy, neurological disease, smoking, spinal cord trauma and pelvic floor injury SUI obviously requires some degree of weakness of both the proximal and distal urethral sphincter mechanisms. Symptoms are typically described as small amount of urine loss. [5]There is an increasing need for UI treatment, given the combination of ageing population and more women seeking treatment. Physical therapy is now recommended as first-line treatment for UI, with better results in relation to drug treatment and surgery.[1]

The first-line treatment for stress urinary incontinence (SUI) is pelvic floor muscle training (PFMT), with success in 60–70% of those who comply[6]. A length of at least three months is recommended for the practice of PFMT to see a major change[7]. Management strategies to reduce the burden of SUI include behavioural changes, weight reduction, pelvic floor muscle therapy (PFMT), and various surgical interventions[8]

In Unani system of medicine to treat such conditions, the renowned Unani physicians have mentioned about the use of drugs having qabiz (astringent), muqawwie dimagh (brain tonic) and muhallil (anti-inflammatory) properties. [9,10,26]. Considering this fact, it has been decided to conduct a clinical trial with polyherbal Unani formulation in the management of stress urinary incontinence. 
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