| CTRI Number |
CTRI/2020/04/024539 [Registered on: 09/04/2020] Trial Registered Prospectively |
| Last Modified On: |
31/03/2020 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Unani |
| Study Design |
Randomized, Parallel Group, Active Controlled Trial |
|
Public Title of Study
|
Management of urinary incontinence in Unani system of medicine. |
|
Scientific Title of Study
|
A Randomized controlled trial to study the effectiveness of Riyazat-e-Juziya for the treatment of Urinary Incontinence among women in a selected Hospital of South Delhi. |
| Trial Acronym |
|
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
ARAF FATMA |
| Designation |
MD Scholar |
| Affiliation |
Jamia Hamdard |
| Address |
Department of Tahaffuzi wa Samaji Tibb.
School of Unani Medical Education and Research, Jamia Hamdard.
South
DELHI
110062
India |
| Phone |
7065185628 |
| Fax |
|
| Email |
afatima.fatima@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
AISHA PERVEEN |
| Designation |
Assistant Professor |
| Affiliation |
Jamia Hamdard |
| Address |
Department of Tahaffuzi wa Samaji Tibb.
School of Unani Medical Education and Research, Jamia Hamdard.
South
DELHI
110062
India |
| Phone |
9818332134 |
| Fax |
|
| Email |
aperveen@jamiahamdard.ac.in |
|
Details of Contact Person
Public Query
|
| Name |
AISHA PERVEEN |
| Designation |
Assistant Professor |
| Affiliation |
Jamia Hamdard |
| Address |
Department of Tahaffuzi wa Samaji Tibb.
School of Unani Medical Education and Research, Jamia Hamdard.
South
DELHI
110062
India |
| Phone |
9818332134 |
| Fax |
|
| Email |
aperveen@jamiahamdard.ac.in |
|
|
Source of Monetary or Material Support
|
|
|
Primary Sponsor
|
| Name |
Jamia Hamdard |
| Address |
Jamia Hamdard, Hamdard Nagar, New Delhi, 110062 |
| Type of Sponsor |
Other [University] |
|
|
Details of Secondary Sponsor
|
| Name |
Address |
| Department of Tahaffuzi Wa Samaji Tibb |
School of Unani Medical Education and Research, Jmaia Hmadard, Hamdard Nagar, New Delhi, 110062 |
|
|
Countries of Recruitment
|
India |
|
Sites of Study
|
| No of Sites = 1 |
| Name of Principal
Investigator |
Name of Site |
Site Address |
Phone/Fax/Email |
| Araf Fatma |
OPD of Tahaffuzi wa Samaji Tibb (Room number 10) and IPD (female ward) of Majeedia Unani Hospital |
Jamia Hamdard, Hamdard Nagar, New Delhi, 110062
South
DELHI |
7065185628
afatima.fatima@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| JAMIA HAMDARD INSTITUTIONAL ETHICS COMMITTEE |
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 |
| Comparator Agent |
Majun Kundur |
Majun Kundur will be given 5 grams twice a day for twelve weeks. |
| Intervention |
Riyazat-e-juziya and Majun Kundur |
This type of exercise is performed to strengthen any organ, group of muscles or any specific part of the body. Majun Kundur will be given 5 grams twice a day for twelve weeks. |
|
|
Inclusion Criteria
|
| Age From |
40.00 Year(s) |
| Age To |
60.00 Year(s) |
| Gender |
Female |
| Details |
1. Females of Age group between 40-60 years.
2. Patients with a complaint of urinary leakage.
3. Patients willing to participate in this study and are available at the time of data collection.
4. Patients who can follow commands in Hindi or English.
5. Clinically stable patients.
|
|
| ExclusionCriteria |
| Details |
1. Patients having a chronic cough, UTI, Diagnosed patients of Diabetes Mellitus.
2. Patients on diuretics.
3. Patients with deranged kidney, hepatic and cardiac profiles.
4. Diagnosed patients of grade three Stress Urinary Incontinence.
5. Patients suffering from 2nd, 3rd or 4th-degree uterine prolapse, Urogenital Malignancy or any previously done pelvic floor surgery.
6. Participation in another study.
7. Diagnosed patients with chronic degenerative or psychiatric disorders.
|
|
|
Method of Generating Random Sequence
|
Computer generated randomization |
|
Method of Concealment
|
An Open list of random numbers |
|
Blinding/Masking
|
Not Applicable |
|
Primary Outcome
|
| Outcome |
TimePoints |
| 1-hour pad testing, ICIQ-FLUTS LF (International Consultation on Incontinence Questionnaire on Female Lower Urinary Tract Symptoms long form) |
0 day and 84th day |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
1. CBC with ESR
2. LFT
3. KFT
4. Urine Routine & Microscopy
|
0 day and 84th day |
|
|
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 2 |
|
Date of First Enrollment (India)
|
15/04/2020 |
| 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) |
Not Yet Recruiting |
|
Publication Details
|
As per the guidelines laid by Jamia Hamdard |
|
Individual Participant Data (IPD) Sharing Statement
|
Will individual participant data (IPD) be shared publicly (including data dictionaries)?
|
|
Brief Summary
|
After getting ethical clearance from the ethical
committee of Jamia Hamdard, Diagnosed female patients of Urinary Incontinence,
fulfilling the inclusion criteria will be included in the study from OPD/IPD of
Majeedia Unani Hospital, Jamia Hamdard New Delhi.
Initially, the patient will be explained about the
nature of the study and informed verbal and written consent in Hindi or
English will be taken from the patient by the researcher. A detailed medical
history, obstetric history, family history as well as sociodemographic data along
with Physical examination will be recorded in the case record form, then the
patient will be allocated to the experimental or control group by randomization
method. Calibration of the pocket scale machine will be obtained which will be
used for the measurement of pad weight. The researcher will receive the training to perform Riyazat-e-Juziya from experts in the concerned field.
In the experimental group, Patients will be
given Majun Kundur 5 grams orally
twice a day, daily for twelve weeks. Along with medicine, the researcher will
provide the demonstration to perform Riyazat-e-Juziya
to the patients in the IBT functional room and a countercheck of Riyazat-e-Juziya understanding of the
patient will be done simultaneously. Supervised Riyazat-e-Juziya will be done every week on follow up and for the
rest of the days patient will perform it daily at home for twelve weeks and
adherence with daily Riyazat-e-Juziya
will be assessed by daily performance sheet.
In the control group, Patients will be given Majun Kundur 5 grams orally twice a day,
daily for twelve weeks. They will not perform Riyazat-e-Juziya.
Change in symptoms of urinary incontinence
will be assessed before and after the intervention with the help of assessment
tools in both experimental as well as in the control group. |