| CTRI Number |
CTRI/2025/04/084062 [Registered on: 03/04/2025] Trial Registered Prospectively |
| Last Modified On: |
21/03/2025 |
| Post Graduate Thesis |
No |
| Type of Trial |
Interventional |
|
Type of Study
|
Nutraceutical |
| Study Design |
Single Arm Study |
|
Public Title of Study
|
Clinical Study on Leakless capsules in female participants with urinary incontinence |
|
Scientific Title of Study
|
An Open Labeled, Prospective, Multi-center, Clinical Study to Evaluate Efficacy and Safety of Leakless capsules in healthy Female participants with urinary incontinence. |
| Trial Acronym |
NIL |
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| UI/TLS/TIMER/01, Version1.0, Dated 6th Feb 2025 |
Protocol Number |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Dr Archana Jadhav |
| Designation |
Associate Professor |
| Affiliation |
Ayurved Seva Sanghs Ayurved Mahavidyala |
| Address |
Department of Prasuti Tantra and Stree Roga,
OPD No. 5, Ground floor, Ayurved Seva Sanghs Ayurved Mahavidyala, Ganeshwadi,
Nashik, India.
Nashik
MAHARASHTRA
422003
India |
| Phone |
7775058616 |
| Fax |
|
| Email |
archujadhav88@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Satyendra Kumar |
| Designation |
Senior Manager- Clinical Research |
| Affiliation |
Transformative Learning Solutions Pvt Ltd |
| Address |
Transformative Learning Solutions Pvt Ltd, 3rd Floor, Veritas Business Suit, Sector 53, Gurgaon, Haryana Gurgaon
HARYANA
Gurgaon
HARYANA
122002
India |
| Phone |
9891253516 |
| Fax |
|
| Email |
satyendra.kumar@transformative.in |
|
Details of Contact Person
Public Query
|
| Name |
Dr Sanjay Tamoli |
| Designation |
Director |
| Affiliation |
Target Institute of Medical Education and Research Pvt. Ltd |
| Address |
Target Institute of Medical Education and Research Pvt. Ltd, A wing 402 A B C, Jaswanti Allied Business Center, Ramchandra Lane Extension, Kachpada, Malad West, Mumbai
Mumbai (Suburban)
MAHARASHTRA
400064
India |
| Phone |
9322522252 |
| Fax |
|
| Email |
targetinstitute@yahoo.com |
|
|
Source of Monetary or Material Support
|
| Transformative Learning Solutions Private Limited
3rd Floor, Veritas Business Suit, Sector 53, Gurgaon, Haryana Gurgaon
|
|
|
Primary Sponsor
|
| Name |
Transformative Learning Solutions Private Limited |
| Address |
3rd Floor, Veritas Business Suit, Sector 53, Gurgaon, Haryana Gurgaon
HARYANA 122002
|
| Type of Sponsor |
Other [Healthcare Industry ] |
|
|
Details of Secondary Sponsor
|
|
|
Countries of Recruitment
|
India |
|
Sites of Study
|
| No of Sites = 2 |
| Name of Principal
Investigator |
Name of Site |
Site Address |
Phone/Fax/Email |
| Dr Archana Jadhav |
Ayurved Seva Sangh’s, Ayurved Mahavidyala, |
Department of Prasuti Tantra and Stree Roga,
OPD No. 5, Ground floor, Ayurved Seva Sanghs Ayurved Mahavidyala, Ganeshwadi,
Nashik-422003, India.
Nashik
MAHARASHTRA |
7775058616
archujadhav88@gmail.com |
| Dr Sarika Londhe |
Nirvikar Ayurveda Hospital |
Department of General OPD,
OPD No. 1, First Floor, Nirvikar Ayurveda Hospital, B Wing, Jay Ganesh Samrajya, Nashik Hwy, Sector No. 3, Bhosari, Pimpri Chinchwad, Pune Maharashtra 411039
Pune
MAHARASHTRA |
7776008686
Sarikalondhe49@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 2 |
| Name of Committee |
Approval Status |
| Institutional Ethics Committee Nirvikar Ayurved Hospital, Pune |
Submittted/Under Review |
| Institutional Ethics Committee, Ayurved Seva Sangh’s Ayurved Mahavidyalaya, Nashik. |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition: N394||Other specified urinary incontinence, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Intervention |
Leakless Capsules |
One capsule in the morning and evening after a meal with water for 12 weeks. |
| Comparator Agent |
NIL |
NIL |
|
|
Inclusion Criteria
|
| Age From |
40.00 Year(s) |
| Age To |
75.00 Year(s) |
| Gender |
Female |
| Details |
1. Healthy Female participants complaining of involuntary loss of urine incontinence persisting for at least 1 month as determined by a score greater than or equal to 5 on the ICIQ-SF questionnaire at the screening visit.
2. Participants complaining of involuntary loss of urine incontinence for 3 or more times during Day and night
3. Female participant not having child-bearing potential (defined as females who have undergone a sterilization procedure like hysterectomy, bilateral oophorectomy, bilateral tubal ligation etc. or have been post-menopausal (natural or surgically) for at least 1 year prior to screening.
5. Participants are willing to follow the procedures as per the study protocol and voluntarily sign an informed consent form.
|
|
| ExclusionCriteria |
| Details |
1. Female undergoing any hospitalized treatment.
2. Participants with BMI less than 18.5 or greater than 35.0 kg per meter square.
3. Participants currently participating or having participated in any other investigational clinical trial within the last 30 days prior to screening.
4. Participants with history of or current severe medical conditions, such as uncontrolled hypertension, diabetes mellitus, thyroid, chronic kidney disease, heart disease, or severe hepatic impairment
5. Participants with neurological conditions like multiple sclerosis, Parkinson disease, spinal cord injuries, or stroke.
6. Females who are pregnant, lactating, or planning to become pregnant during the study period.
7. Participants with active or recurrent urinary tract infections within 30 days prior of screening
8. Participants who have undergone previous surgical interventions for urinary incontinence within the past 12 months.
9. History of interstitial cystitis, bladder cancer, bladder stones, or any major urological condition requiring intervention within the past 6 months.
10. Known hypersensitivity or allergy to the ingredients of the study product
11. Participants on medications like diuretics, anticholinergics, or alpha-blockers, unless they have been on a stable dose for at least 3 months prior to screening.
12. Participants with current or past 12 month history of drug abuse or alcohol dependency, as well as the use of recreational drugs.
|
|
|
Method of Generating Random Sequence
|
Not Applicable |
|
Method of Concealment
|
Not Applicable |
|
Blinding/Masking
|
Not Applicable |
|
Primary Outcome
|
| Outcome |
TimePoints |
| Assessment of bladder muscle tone and elasticity by evaluating change in severity of urinary incontinence symptoms on ICIQ-SF and participant diary |
Screening visit, week 1, week 2, week 4, weeks 8, week 12 |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
1. Assessment of changes or difference in stress-induced urinary incontinence as per subject diary
2. Assessment of change or difference in frequency of nocturia as per subject diary.
3. Assessment of change or difference in frequency of daytime urination as per subject diary.
4. Assessment of change in urinary incontinence- related quality of life
5. Assessment of change in urinary symptoms related to female lower urinary tract symptoms and impact on quality of life
6. Assessment of change in sleep quality or efficiency as per subject diary.
7. Assessment of requirement of rescue medications as per subject diary
8. Change in Global evaluation for overall change by subject and investigator
9. Assessment of tolerability of the study product by assessing adverse events
10. Safety of study products through clinical and laboratory assessment
11. Safety Evaluation through assessments of adverse events.
|
Screening visit, week 1, week 2, week 4, weeks 8, week 12 |
|
|
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/ Phase 3 |
|
Date of First Enrollment (India)
|
03/04/2025 |
| 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="0"
Days="0" |
|
Recruitment Status of Trial (Global)
|
Not Applicable |
| Recruitment Status of Trial (India) |
Open to Recruitment |
|
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
|
It
is an open labeled, prospective, multi-center, clinical study to evaluate efficacy
and safety of Leakless capsules in healthy female participants with urinary
incontinence. The study will be carried out at 3 to 4 centers in India. Participants
will be given one capsule in the morning and evening after a meal with water
for 12 weeks. The primary objective of the study will be to assess bladder muscle tone and elasticity by
evaluating change in severity of urinary incontinence symptoms on ICIQ-SF and
participant diary. The secondary objectives of the study will be to assess changes
or difference in stress-induced urinary incontinence as per subject diary, change
or difference in frequency of nocturia as per subject diary, change or difference
in frequency of daytime urination as per subject diary, change in urinary
incontinence- related quality of life, change in urinary symptoms related to female
lower urinary tract symptoms and impact on quality of life, change in sleep
quality or efficiency as per subject diary, requirement of rescue medications
as per subject diary, change in Global evaluation for overall change by subject
and investigator, tolerability of the study product by assessing adverse events,
safety of study products through clinical and laboratory assessment and safety
Evaluation through assessments of adverse events on screening visit, week 1, week 2, week 4, weeks 8, week 12. |