| 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
|
|
|
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
|
|
|
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 |