| CTRI Number |
CTRI/2023/02/049525 [Registered on: 07/02/2023] Trial Registered Prospectively |
| Last Modified On: |
07/02/2023 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Observational |
|
Type of Study
|
Case Control Study |
| Study Design |
Other |
|
Public Title of Study
|
To correlate the features of Taila Bindu Pariksha with Serum Urea and Creatinine in Renal Failure patients before and after dialysis. |
|
Scientific Title of Study
|
Correlation of Serum Biochemical markers with the features of Taila Bindu Pariksha in Renal Failure before and after dialysis. |
| Trial Acronym |
|
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Dr Sushree Susmita Bhuyan |
| Designation |
MD Scholar |
| Affiliation |
Institute of Medical Sciences BHU |
| Address |
Department of Vikriti Vigyan
Faculty of Ayurveda
Institute of Medical Sciences
Banaras Hindu University Varanasi
Varanasi
UTTAR PRADESH
221005
India |
| Phone |
8658614636 |
| Fax |
|
| Email |
smita96sb@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Prof A C Kar |
| Designation |
Professor |
| Affiliation |
Institute of Medical Sciences BHU |
| Address |
Department of Vikriti Vigyan
Faculty of Ayurveda
Institute of Medical Sciences
Banaras Hindu University Varanasi
Varanasi
UTTAR PRADESH
221005
India |
| Phone |
9415381727 |
| Fax |
|
| Email |
karanukul@rediffmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Prof A C Kar |
| Designation |
Professor |
| Affiliation |
Institute of Medical Sciences BHU |
| Address |
Department of Vikriti Vigyan
Faculty of Ayurveda
Institute of Medical Sciences
Banaras Hindu University Varanasi
Varanasi
UTTAR PRADESH
221005
India |
| Phone |
9415381727 |
| Fax |
|
| Email |
karanukul@rediffmail.com |
|
|
Source of Monetary or Material Support
|
|
|
Primary Sponsor
|
| Name |
Head of Department of Vikriti Vigyan |
| Address |
Department of Vikriti Vigyan
Faculty of Ayurveda
Institute of Medical Sciences
Banaras Hindu University Varanasi |
| 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 |
| Prof A C Kar |
SS Hospital |
Department of Nephrology
Institute of Medical Sciences
Varanasi
UTTAR PRADESH |
9415381727
karanukul@rediffmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Institute Ethical Committee Institute of Medical Sciences SS Hospital BHU |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition: N19||Unspecified kidney failure, |
|
|
Intervention / Comparator Agent
|
| sno | Intervention/Comparator | Type | Drug-Type | Procedure Name | Details |
|
|
|
Inclusion Criteria
|
| Age From |
10.00 Year(s) |
| Age To |
70.00 Year(s) |
| Gender |
Both |
| Details |
1 AKI having stage 3 as per KDIGO criteria advised for dialysis
2 CKD as per KDIGO criteria advised for dialysis
3 All age group irrespective of sex |
|
| ExclusionCriteria |
| Details |
1 AKI having stage 1 and 2 as per KDIGO criteria
2 AKI and CKD having oliguria |
|
|
Method of Generating Random Sequence
|
Not Applicable |
|
Method of Concealment
|
|
|
Blinding/Masking
|
|
|
Primary Outcome
|
| Outcome |
TimePoints |
| To Correlate the level of Serum Urea and Creatinine with the features of Taila Bindu Pariksha in Renal failure before and after Dialysis |
Before Dialysis and immediately after Dialysis |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| To compare the features of TBP in Renal Failure patients with healthy volunteers |
one year |
|
|
Target Sample Size
|
Total Sample Size="110"
Sample Size from India="110"
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)
|
01/03/2023 |
| 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="4"
Days="0" |
|
Recruitment Status of Trial (Global)
|
Not Applicable |
| Recruitment Status of Trial (India) |
Not Yet Recruiting |
|
Publication Details
|
|
|
Individual Participant Data (IPD) Sharing Statement
|
Will individual participant data (IPD) be shared publicly (including data dictionaries)?
Response - NO
|
|
Brief Summary
|
55 patients of Renal Failure will be selected and their Urine will be subjected to Taila Bindu Pariksha to compare the features with Serum Biochemical markers before and after dialysis . On the same day of recruitment of patients an apparently healthy volunteer will be selected and the urine sample will be subjected to Taila Bindu Pariksha to compare its features with the features of Taila Bindu Pariksha in Renal Failure patients. |