| CTRI Number |
CTRI/2024/04/065778 [Registered on: 16/04/2024] Trial Registered Prospectively |
| Last Modified On: |
10/04/2024 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Drug
Ayurveda
Other (Specify) [Kegel exercise] |
| Study Design |
Randomized, Parallel Group, Active Controlled Trial |
|
Public Title of Study
|
A study to compare the effect of Kegel exercise with Baladi churna and Kegel exercise without Baladi churna in women
with urine leakage during coughing and sneezing. |
|
Scientific Title of Study
|
An open label double arm clinical study to compare the effect of kegel exercise with and without Baladi choorna in women with mild to moderate 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 Sandra K S |
| Designation |
PG Scholar |
| Affiliation |
Amrita School Of Ayurveda |
| Address |
Department Of Stri Roga and Prasuti Tantra
Amrita School Of Ayurveda
Amrita Vishwa vidyapeetham
Amritapuri Campus
Clappana P.O
Kollam Kerala
Kollam
KERALA
690525
India |
| Phone |
8589986403 |
| Fax |
|
| Email |
drsandraksubran@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Anjaly M V |
| Designation |
Associate Professor and Guide |
| Affiliation |
Amrita School Of Ayurveda |
| Address |
Department Of Stri Roga and Prasuti Tantra
Amrita School Of Ayurveda
Amrita Vishwa Vidyapeetham
Amritapuri Campus
Clappana PO Kollam
Kollam
KERALA
690525
India |
| Phone |
9495114149 |
| Fax |
|
| Email |
anjalymvarier@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Dr Anjaly M V |
| Designation |
Associate Professor and Guide |
| Affiliation |
Amrita School Of Ayurveda |
| Address |
Department Of Stri Roga and Prasuti Tantra
Amrita School Of Ayurveda
Amrita Vishwa Vidyapeetham
Amritapuri Campus
Clappana PO
Kollam
Kollam
KERALA
690525
India |
| Phone |
9495114149 |
| Fax |
|
| Email |
anjalymvarier@gmail.com |
|
|
Source of Monetary or Material Support
|
| Amrita School Of Ayurveda
Amrita Vishwa Vidyapeetham
Amritapuri Campus
Clappana PO Kollam |
|
|
Primary Sponsor
|
| Name |
Amrita School Of Ayurveda |
| Address |
Amrita Vishwa Vidyapeetham
Amritapuri Campus
Clappana PO 690525
Kollam Kerala |
| 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 |
| Dr Sandra K S |
Amrita School Of Ayurveda |
OPD and IPD Department Of Stri Roga and Prasuti Tantra
Amrita Vishwa Vidyapeetham
Amritapuri Campus
Clappana PO 690525
Kollam Kerala
Kollam
KERALA |
8589986403
drsandraksubran@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| IEC Amrita School Of Ayurveda |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition:N393||Stress incontinence (female) (male). Ayurveda Condition: BASTIGATA-PRATILOMAVATAH/BASTIGATA-VIGUNAVATAH, |
|
|
Intervention / Comparator Agent
|
| sno | Intervention/Comparator | Type | Drug-Type | Procedure Name | Details | | 1 | Comparator Arm (Non Ayurveda) | | - | Kegel exercise | 10 sets of contractions per day (10 repetitions per set) for 56 days | | 2 | Intervention Arm | Drug | Classical | | (1) Medicine Name: Baladi churna, Reference: Bhavaprakasha madhyama khanda vatavyadi adhikara , Route: Oral, Dosage Form: Churna/ Powder, Dose: 6(g), Frequency: bd, Bhaishajya Kal: Abhakta, Duration: 12 Months, anupAna/sahapAna: Yes(details: -milk), Additional Information: -Baladi churna include churna of bala murva and tvak all these together of 6 gm taken along with 100 ml of milk twice daily before food |
|
|
|
Inclusion Criteria
|
| Age From |
40.00 Year(s) |
| Age To |
70.00 Year(s) |
| Gender |
Female |
| Details |
Parous women of age from 40 to 70 years.
Positive on cough stress test with simultaneous expulsion of urine along with cough.
Positive pad test with gain of greater than 1 g in the 1-hour pad test. |
|
| ExclusionCriteria |
| Details |
Participants with clinical presentation of other type of incontinence like, UUI, MUI
Participants diagnosed with stress urinary incontinence associated with pelvic organ prolapse and hysterectomy.
Participants diagnosed of Urinary Tract Infection. Participants diagnosed with Diabetes Mellitus.
Participants allergic towards milk.
Participants with urine leakage of greater than or equal to 50gm on 1 hour pad test. |
|
|
Method of Generating Random Sequence
|
Coin toss, Lottery, toss of dice, shuffling cards etc |
|
Method of Concealment
|
Not Applicable |
|
Blinding/Masking
|
Not Applicable |
|
Primary Outcome
|
| Outcome |
TimePoints |
| Reduction in quantity of urine leakage by 1 hour pad test by weighing the pad |
Assessment by 1 hour pad test by weighing the pad is done on Day 1 and Day 57 |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| Improvement in Quality of Life by ICIQ-LUTS QoL Questionnaire |
Assessment by ICIQ-LUTS QoL Questionnaire is done on Day 1 and Day 57 |
|
|
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 3 |
|
Date of First Enrollment (India)
|
01/05/2024 |
| 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="0"
Months="7"
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
|
This study is a open-label double arm clinical study to compare the effect of Kegel exercise with and without 6gm of Baladi curna twice daily for a period of 56 days in Women with Mild to Moderate Stress Urinary Incontinence. The study will be conducted in the OPD and IPD of Striroga and Prasuti tantra Deoartment of Amrita School of Ayurveda, Kollam, India. The primary outcome measures will be reduction in quantity of urine leakage assessed by 1 hour pad test by weighing the pad, and the secondary outcome will be improvement in Quality of Life by ICIQ-LUTS QoL Questionnaire. The assessment for both will be done on Day 1 and Day 57.
|