| 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
|
|
|
Primary Sponsor
|
| Name |
shahila nigar |
| Address |
luqman unani medical college and hospital |
| Type of Sponsor |
Private 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 |
| 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
|
|
|
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. |