| CTRI Number |
CTRI/2025/03/082588 [Registered on: 18/03/2025] Trial Registered Prospectively |
| Last Modified On: |
18/03/2025 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Observational |
|
Type of Study
|
Observational |
| Study Design |
Other |
|
Public Title of Study
|
A study to assess the difference in effects of urolithiasis on the quality of life among different deha prakriti individuals. |
|
Scientific Title of Study
|
An Observational Study To Assess The Difference In Quality Of Life In Different Deha Prakruti Among Known Cases Of Urolithiasis |
| 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 Preetesh Rajesh Kumbhare |
| Designation |
MD Scholar Kriya Sharir |
| Affiliation |
Dr D Y Patil college Of Ayurved And Research Centre Pimpri Pune |
| Address |
Department Of Kriya Sharir Dr D Y Patil College Of Ayurveda And Research Centre Sant Tukaram Nagar Pimpri Pune
Pune
Maharashtra
411018
India
Pune
MAHARASHTRA
411018
India |
| Phone |
7219366859 |
| Fax |
|
| Email |
preeteshk96@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Dushyant Patil |
| Designation |
Assistant Professor Kriya Sharir |
| Affiliation |
Dr DY Patil college Of Ayurved And Research Centre Pimpri Pune |
| Address |
Department Of Kriya Sharir, Dr. D. Y. Patil College Of Ayurveda And Research Centre, Sant Tukaram Nagar, Pimpri, Pune.
Maharashtra
411018
India
Pune
MAHARASHTRA
411018
India |
| Phone |
9970348007 |
| Fax |
|
| Email |
dr.dushyant.p39@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Dr Dushyant Patil |
| Designation |
Assistant Professor Kriya Sharir |
| Affiliation |
Dr D Y Patil college Of Ayurved And Research Centre Pimpri Pune |
| Address |
Department Of Kriya Sharir Dr D Y Patil College Of Ayurveda And Research Centre Sant Tukaram Nagar Pimpri Pune
Pune
Maharashtra
411018
India
Pune
MAHARASHTRA
411018
India |
| Phone |
9970348007 |
| Fax |
|
| Email |
dr.dushyant.p39@gmail.com |
|
|
Source of Monetary or Material Support
|
| Dr.D.Y.Patil College Of Ayurveda and Research Centre Sant Tukaram nagar Pimpri Pune Maharashtra India 411018 |
|
|
Primary Sponsor
|
| Name |
Dr Preetesh Rajesh Kumbhare |
| Address |
Dr.D.Y.Patil College Of Ayurveda and Research Centre Sant Tukaram nagar Pimpri Pune 411018
|
| Type of Sponsor |
Other [self] |
|
|
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 Dushyant Patil |
Dr.D.Y.Patil vidyapeeth, Pimpri, Pune |
1.Department or OPD of Urology, Dr.D.Y.Patil Medical College, Sant Tukaram Nagar, Pimpri, Pune
2. Dr.D.Y.Patil College of Ayurved And Research Centre,Sant Tukaram Nagar, Pimpri, Pune
Pune
MAHARASHTRA |
7219366859
preeteshk96@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Institutional Ethics Committee |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Healthy Human Volunteers |
Persons having renal calculus. |
|
|
Intervention / Comparator Agent
|
| sno | Intervention/Comparator | Type | Drug-Type | Procedure Name | Details |
|
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
60.00 Year(s) |
| Gender |
Both |
| Details |
The Patients Who duly signed the consent form will be considered.
Patients with ureteric calculus, pelvic ureteric junction calculus and ureteric calculus of size less than 10 mm will be considered.
All types of stones will be considered. |
|
| ExclusionCriteria |
| Details |
K/C/O- Diabetes mellitus, Hypertension, Asthma, and Significant Respiratory illness, cases of Pregnency, Cancer patients. |
|
|
Method of Generating Random Sequence
|
Not Applicable |
|
Method of Concealment
|
Case Record Numbers |
|
Blinding/Masking
|
Not Applicable |
|
Primary Outcome
|
| Outcome |
TimePoints |
| Any differences in effects of urolithiasis on the quality of life among different deha prakriti. |
0th day. |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| Quality of life of which type of deha prakriti is more affected by urolithiasis. |
0th day |
|
|
Target Sample Size
|
Total Sample Size="65"
Sample Size from India="65"
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
|
N/A |
|
Date of First Enrollment (India)
|
01/04/2025 |
| 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="0"
Months="10"
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
|
Patients (both male and female) of urolithiasis of age between 18-60 yrs who will sign consent form will be considered. Patients with lower ureteric calculus, pelvic ureteric calculus and ureteric calculus of size less than 10 mm will be considered. For record USG (A+P) or X-RAY KUB will be considered. Prakriti of patients will be assessed with the help of questionnaire developed by kishore patwardhan. Effect of urolithiasis on quality of life will be assessed by PROMIS (patient reported outcomes measurement information system) questionnaire. Like this prakriti and effect of urolithiasis on quality of life of each patients will be asessed and data will be obtained. From data collected Quality of life of which type of prakriti is affected more will be assessed and conclusion will be drawn. |