| CTRI Number |
CTRI/2025/01/079144 [Registered on: 21/01/2025] Trial Registered Prospectively |
| Last Modified On: |
21/01/2025 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Observational |
|
Type of Study
|
Cross Sectional Study |
| Study Design |
Single Arm Study |
|
Public Title of Study
|
observation of features of oil drop test of urine in Liver Cirrhosis |
|
Scientific Title of Study
|
To study the features of Taila Bindu Pariksha in Liver cirrhosis |
| Trial Acronym |
nil |
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Ranjana Yadav |
| Designation |
Junior resident |
| Affiliation |
Institute of medical Sciences,Banaras Hindu University |
| Address |
Department of Vikriti Vigyana
Faculty of Ayurveda,Institute of medical Sciences,Banaras Hindu University
Varanasi
UTTAR PRADESH
221005
India |
| Phone |
7800604218 |
| Fax |
|
| Email |
yadavranjana149@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr. A.C. Kar |
| Designation |
Professor |
| Affiliation |
Institute of medical sciences,Banaras Hindu University |
| Address |
Department of Vikriti Vigyana
Faculty of Ayurveda,Institute of medical sciences,Banaras Hindu University
Varanasi
UTTAR PRADESH
221005
India |
| Phone |
9415381727 |
| Fax |
|
| Email |
karanukul@rediffmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Ranjana Yadav |
| Designation |
Junior resident |
| Affiliation |
Institute of medical sciences,Banaras Hindu University |
| Address |
Department of Vikriti Vigyana
Faculty of Ayurveda,Institute of medical sciences,Banaras Hindu University
Varanasi
UTTAR PRADESH
221005
India |
| Phone |
7800604218 |
| Fax |
|
| Email |
yadavranjana149@gmail.com |
|
|
Source of Monetary or Material Support
|
| Department of Vikriti Vigyan, Faculty of Ayurveda,Institute of Medical Sciences,B.H.U,Varanasi,221005, U.P India |
|
|
Primary Sponsor
|
| Name |
Head of the Department |
| Address |
Department of Vikriti Vigyan Faculty of Ayurveda, Institute of Medical Sciences, Banaras Hindu University, Varanasi,221005, U.P, India |
| 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 Ranjana Yadav |
SS Hospital, Institute of Medical Sciences |
Room No. G19, Gastroenterology Department Super Specialty Block, SS Hospital, B.H.U. Varansi,221005, U.P, India
Varanasi
UTTAR PRADESH |
7800604218
yadavranjana149@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 |
| Patients |
(1) ICD-10 Condition:K746||Other and unspecified cirrhosis ofliver. Ayurveda Condition: YAKRUDDALYUDARAH, |
|
|
Intervention / Comparator Agent
|
| sno | Intervention/Comparator | Type | Drug-Type | Procedure Name | Details |
|
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
70.00 Year(s) |
| Gender |
Both |
| Details |
All Liver cirrhosis Patients irrespective of age,sex,gendre and MELD score |
|
| ExclusionCriteria |
| Details |
Those who are not willing to participate.
Those patients who are on catheter |
|
|
Method of Generating Random Sequence
|
Not Applicable |
|
Method of Concealment
|
Not Applicable |
|
Blinding/Masking
|
Not Applicable |
|
Primary Outcome
|
| Outcome |
TimePoints |
| Compare the features of Taila Bindu Pariksha of urine of Liver Cirrhosis patients with MELD score |
Base Line |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
Comparison of shape, direction, rate of spread of oil drop on urine of Liver cirrhosis patients with the urine of apparently healthy individual.
|
0 Day |
|
|
Target Sample Size
|
Total Sample Size="70"
Sample Size from India="70"
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)
|
06/02/2025 |
| 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="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
|
Total of 35 cases of diagnosed cases of liver cirrhosis will be selected and will be subjected to Taila Bindu Pariksha of urine. The features of Taila Bindu Pariksha Will be compared with the MELD score to ascertain the prognosis of Liver cirrhosis.35 cases of apparently healthy volunteers will be selected and subjected to Taila Bindu Pariksha of urine to serve as a control. The features of Taila Bindu Pariksha of healthy volunteers and Liver cirrhosis will be compared. |