| CTRI Number |
CTRI/2026/01/101298 [Registered on: 15/01/2026] Trial Registered Prospectively |
| Last Modified On: |
14/01/2026 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Drug
Ayurveda
Other (Specify) |
| Study Design |
Randomized, Parallel Group Trial |
|
Public Title of Study
|
Study to compare an Ayurvedic Herbal Formulation with Pelvic Floor Exercise for Urinary Leakage in Elderly Female |
|
Scientific Title of Study
|
A CLINICAL STUDY TO COMPARE THE EFFICACY OF PRASARINYADI YOGAH AND KEGELS EXERCISE IN MUTRAVAHA STROTODUSHTI ATIPRAVRITTI W.S.R. URINARY INCONTINENCE (UI) IN ELDERLY FEMALE |
| 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 Smruti Ganesh Hedau |
| Designation |
MD Scholar |
| Affiliation |
Chaudhary Brahm Prakash Ayurved Charak Sansthan Khera Dabar ,Najafgarh, New Delhi |
| Address |
Room no 108,Department of Kayachikitsa,Chaudhary Brahm Prakash Ayurved Charak Sansthan,Khera Dabar,Najafgarh South West DELHI 110073
South West
DELHI
110073
India |
| Phone |
9960920922 |
| Fax |
|
| Email |
smrutihedau@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Prof Dr N R Singh |
| Designation |
Professor (Department of Kayachikitsa) |
| Affiliation |
Chaudhary Brahm Prakash Ayurved Charak Sansthan Khera Dabar ,Najafgarh, New Delhi |
| Address |
Room no 146,Department of Kayachikitsa,Chaudhary Brahm Prakash Ayurved Charak Sansthan,Khera Dabar,Najafgarh South West DELHI 110073
South West
DELHI
110073
India |
| Phone |
9560659728 |
| Fax |
|
| Email |
naimishraj@yahoo.com |
|
Details of Contact Person
Public Query
|
| Name |
Prof Dr N R Singh |
| Designation |
Professor (Department of Kayachikitsa) |
| Affiliation |
Chaudhary Brahm Prakash Ayurved Charak Sansthan Khera Dabar ,Najafgarh, New Delhi |
| Address |
Room no 146,Department of Kayachikitsa,Chaudhary Brahm Prakash Ayurved Charak Sansthan,Khera Dabar,Najafgarh South West DELHI 110073
South West
DELHI
110073
India |
| Phone |
9560659728 |
| Fax |
|
| Email |
naimishraj@yahoo.com |
|
|
Source of Monetary or Material Support
|
| Chaudhary Brahm Prakash Ayurved Charak Sansthan Khera Dabar Najafgarh South West New Delhi 110073 |
|
|
Primary Sponsor
|
| Name |
Chaudhary Brahm Prakash Ayurved Charak Sansthan |
| Address |
Chaudhary Brahm Prakash Ayurved Charak Sansthan Khera Dabar Najafgarh South West New Delhi 110073 |
| 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 Smruti Ganesh Hedau |
Chaudhary Brahm Prakash Ayurved Charak Sansthan |
Room no 108 PG Department of Kayachikitsa,Chaudhary Brahm Prakash Ayurved Charak Sansthan,Khera Dabar South West Delhi 110073
South West
DELHI |
9960920922
smrutihedau@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| IEC CBPACS |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition:N394||Other specified urinary incontinence. Ayurveda Condition: MUTRAVAHASROTODUSHTIH, |
|
|
Intervention / Comparator Agent
|
| sno | Intervention/Comparator | Type | Drug-Type | Procedure Name | Details | | 1 | Intervention Arm | Drug | Classical | | (1) Medicine Name: Prasarinyadi Yogah , Reference: Sahastra Yoga, Route: Oral, Dosage Form: Ksheerpaka, Dose: 40(ml), Frequency: bd, Bhaishajya Kal: Pragbhakta, Duration: 45 Days, anupAna/sahapAna: No, Additional Information: - | | 2 | Comparator Arm (Non Ayurveda) | | - | Kegels exercise | Participants are advised to do Kegels exercise by voluntarily contracting perineal muscles as if to stop the urge of micturition. It is done as 10 contractions each 10 times a day for 6 weeks. |
|
|
|
Inclusion Criteria
|
| Age From |
45.00 Year(s) |
| Age To |
70.00 Year(s) |
| Gender |
Female |
| Details |
1.Subjects of age between 45-70 years. 2.Only female subjects will be included. 3.Subjects complaining of involuntary leakage of urine at least since 1 month. 4.Subjects in whom ICIQ-UI (SF) score will found equal to or more than 5 at the time of screening visit. 5.Subjects who are willing to sign the informed consent for participating in the study. 6. Subjects who are able to take medicine orally. |
|
| ExclusionCriteria |
| Details |
1.Subjects not willing to sign the informed consent for participating in the study. 2.Subjects suffering from severe systemic diseases such as – UTI, Kidney Stone, bladder stone, spinal disorders (pudendal nerve disorders), malignancy etc. 3.Pregnant ladies and Lactating mother. 4.Subjects having uncontrolled diabetes, uncontrolled hypertension. 5.Subjects already registered in any other research work. 6.Subjects not able to take medicine orally. |
|
|
Method of Generating Random Sequence
|
Other |
|
Method of Concealment
|
Sequentially numbered, sealed, opaque envelopes |
|
Blinding/Masking
|
Open Label |
|
Primary Outcome
|
| Outcome |
TimePoints |
1.Improvement in symptoms of UI assessed by ICIQ-UI SF questionnaire
2.Change in cough stress test. |
9,27,45 and 60 days |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
1.Improvement in quality of life of patient assessed through IIQ-7 questionnaire
2. Reduction in voiding diary score (frequency, time, quantity). |
9,27,45 and 60 |
|
|
Target Sample Size
|
Total Sample Size="60"
Sample Size from India="60"
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 3/ Phase 4 |
|
Date of First Enrollment (India)
|
02/03/2026 |
| 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 Applicable |
| 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 is a common geriatric health problem that significantly affects quality of life. In Ayurveda, this condition can be correlated with dysfunction of the Mutravaha Srotas leading to excessive urinary flow (Atipravritti). In group A , Prasarinyadi Yogah will be administered in the form of Ksheerpaka , 40 ml , twice daily before food and in group B Kegel’s Exercise will be administered as 10 contractions each 10 times a day for45 days .Outcome measures will include improvement in urinary symptoms, frequency of incontinence episodes, and quality of life.The results of this study are expected to provide evidence-based support for an integrative and non-invasive approach in the management of urinary incontinence among elderly women. |