| CTRI Number |
CTRI/2025/02/080723 [Registered on: 18/02/2025] Trial Registered Prospectively |
| Last Modified On: |
14/02/2025 |
| Post Graduate Thesis |
No |
| Type of Trial |
Observational |
|
Type of Study
|
Cross Sectional Study |
| Study Design |
Single Arm Study |
|
Public Title of Study
|
To scientifically validate and to develop an automated instrument to perform Oil drop test of urine. |
|
Scientific Title of Study
|
Standardization, scientific validation and automation of Taila Bindu Pariksha- an ancient prognostic tool |
| Trial Acronym |
NIL |
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Anukul Chandra Kar |
| Designation |
Professor |
| Affiliation |
Faculty of Ayurveda, Institute of Medical Sciences, Banaras Hindu University |
| Address |
Department of Vikriti Vigyan
Faculty of Ayurveda
Institute of Medical Sciences
Banaras Hindu University
Varanasi, UP, India
Varanasi
UTTAR PRADESH
221005
India |
| Phone |
9415381727 |
| Fax |
|
| Email |
karanukul@rediffmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Anukul Chandra Kar |
| Designation |
Professor |
| Affiliation |
Faculty of Ayurveda, Institute of Medical Sciences, Banaras Hindu University |
| Address |
Department of Vikriti Vigyan
Faculty of Ayurveda
Institute of Medical Sciences
Banaras Hindu University
Varanasi, UP, India
UTTAR PRADESH
221005
India |
| Phone |
9415381727 |
| Fax |
|
| Email |
karanukul@rediffmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Anukul Chandra Kar |
| Designation |
Professor |
| Affiliation |
Faculty of Ayurveda, Institute of Medical Sciences, Banaras Hindu University |
| Address |
Department of Vikriti Vigyan
Faculty of Ayurveda
Institute of Medical Sciences
Banaras Hindu University
Varanasi, UP, India
UTTAR PRADESH
221005
India |
| Phone |
9415381727 |
| Fax |
|
| Email |
karanukul@rediffmail.com |
|
|
Source of Monetary or Material Support
|
| Central Council for Research in Ayurvedic Sciences, 61-65 institutional Area, Janakpuri, New Delhi 110058 India |
|
|
Primary Sponsor
|
| Name |
Director General, CCRAS |
| Address |
Central Council for research in Ayurvedic Sciences, 61-65 Institutional Area, Janakpuri, New Delhi 110058 India |
| Type of Sponsor |
Research institution |
|
|
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 |
| Anukul Chandra Kar |
S S Hospital,Institute of Medical Sciences |
Room No. 3
Clinical Laboratory (IM)
1st Floor, Ayurveda Wing
S S Hospital, 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 |
| Institutional Ethics Committee |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Healthy Human Volunteers |
Apparently healthy volunteers |
|
|
Intervention / Comparator Agent
|
| sno | Intervention/Comparator | Type | Drug-Type | Procedure Name | Details |
|
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
25.00 Year(s) |
| Gender |
Both |
| Details |
1. Participants having normal urine parameters and normal LFT and RFT
2. Participants having no severe diseases and no medication in last seven days
3. Participants who will be able to give written informed consent |
|
| ExclusionCriteria |
| Details |
1. Participants having abnormal LFT and RFT and abnormality in urine examination
2. Participants enrolled in any other study
3. Participant to whom the investigator thinks will jeopardize the study |
|
|
Method of Generating Random Sequence
|
Not Applicable |
|
Method of Concealment
|
Not Applicable |
|
Blinding/Masking
|
Not Applicable |
|
Primary Outcome
|
| Outcome |
TimePoints |
Fabrication of an automated device to
minimize the variations in standardized
parameters |
At Baseline |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
1. Establishment of the reference value of Taila Bindu Pariksha in healthy individuals
2. Scientific validation of Taila Bindu Pariksha |
At Baseline |
|
|
Target Sample Size
|
Total Sample Size="225"
Sample Size from India="225"
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)
|
03/03/2025 |
| 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="2"
Months="0"
Days="0" |
|
Recruitment Status of Trial (Global)
|
Not Yet Recruiting |
| 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
|
An automated device will be fabricated to minimize the manual errors. After fabrication of the automated device, a total of 225 human healthy volunteers will be selected after confirming their normal health condition and their urine will be subjected to Taila Bindu Pariksha. The data will be recorded and will be analyzed for establishing normal reference value for Taila Bindu Pariksha in healthy people
|