| CTRI Number |
CTRI/2024/04/066384 [Registered on: 26/04/2024] Trial Registered Prospectively |
| Last Modified On: |
31/10/2025 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Observational |
|
Type of Study
|
Case Control Study |
| Study Design |
Other |
|
Public Title of Study
|
TONGUE EXAMINATION IN KIDNEY STONE DISEASES AN OBSERVATIONAL STUDY |
|
Scientific Title of Study
|
AN OBSERVATIONAL STUDY OF JIHWA PARIKSHA IN ASHMARI VIKARA WITH SPECIAL REFERENCE TO 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 Bhargav Thakor |
| Designation |
PG Scholar |
| Affiliation |
Parul Institute Of Ayurved |
| Address |
Department of PG & Ph.D studies in Roga Nidana Evum Vikriti
Vigyana, Parul Institute of Ayurved, Parul University,P.O. Limda, Tal.
Waghodia, Dist. Vadodara
Vadodara
GUJARAT
391760
India
Vadodara
GUJARAT
391760
India |
| Phone |
08849382997 |
| Fax |
|
| Email |
thakorbhargav22@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Sachin Deva |
| Designation |
Professor |
| Affiliation |
Parul Institute of Ayurved |
| Address |
Department of PG & Ph.D studies in Roga Nidana Evum Vikriti
Vigyana, Parul Institute of Ayurved, Parul University,P.O. Limda, Tal.
Waghodia, Dist. Vadodara
Vadodara
GUJARAT
391760
India
Vadodara
GUJARAT
391760
India |
| Phone |
9844810957 |
| Fax |
|
| Email |
sachin.deva@paruluniversity.ac.in |
|
Details of Contact Person
Public Query
|
| Name |
Dr Bhargav Thakor |
| Designation |
PG Scholar |
| Affiliation |
Parul Institute Of Ayurved |
| Address |
Department of PG & Ph.D studies in Roga Nidana Evum Vikriti
Vigyana, Parul Institute of Ayurved, Parul University,P.O. Limda, Tal.
Waghodia, Dist. Vadodara
Vadodara
GUJARAT
391760
India
Vadodara
GUJARAT
391760
India |
| Phone |
08849382997 |
| Fax |
|
| Email |
thakorbhargav22@gmail.com |
|
|
Source of Monetary or Material Support
|
| Parul Institute of Ayurved
Parul University,
P.O. Limda,
Tal. Waghodia,
Dist. Vadodara
Vadodara
GUJARAT
391760
India |
|
|
Primary Sponsor
|
| Name |
PARUL INSTITUTE OF AYURVED |
| Address |
Department of PG & Ph.D studies in Roga Nidana Evum Vikriti
Vigyana, Parul Institute of Ayurved, Parul University,P.O. Limda, Tal.
Waghodia, Dist. Vadodara
Vadodara
GUJARAT
391760
India |
| Type of Sponsor |
Private 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 Bhargav Thakor |
Parul Ayurved Hospital,Khemdas Ayurved Hospital,Parul Sevashram Hospital |
OPD NO. 116&08(Kayachikitsa)IPD NO.201,203,205,301,302(Kayachikitsa)Parul university,P.O.Lomda,
Tal-Waghodiya
Vadodara
GUJARAT
Vadodara
GUJARAT |
08849382997
thakorbhargav22@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| INSTITUTIONAL ETHICS COMMITTIEE(IEC) PARUL INSTITUTE OF AYURVED PARUL UNIVERSITY |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition:N202||Calculus of kidney with calculus of ureter. Ayurveda Condition: ASMARI, |
|
|
Intervention / Comparator Agent
|
| sno | Intervention/Comparator | Type | Drug-Type | Procedure Name | Details |
|
|
|
Inclusion Criteria
|
| Age From |
20.00 Year(s) |
| Age To |
60.00 Year(s) |
| Gender |
Both |
| Details |
1) Selection of patients will be done irrespective of gender, socioeconomic status.
2) The healthy individuals between the age of 18-60 years will be included in group A. (Control group).
3)The diagnosed patients of Ashmari Vikara between 18-60 years will be included in group B. (Test group).
|
|
| ExclusionCriteria |
| Details |
2)Patient with local tongue infection and congenital anomalies will be excluded.
2)Patients having major ailments of other systems. E.g., AIDS, carcinoma of any organs, pregnancy, Hepatitis B, Hepatitis C, Tuberculosis at the time of enrolling the patient.
|
|
|
Method of Generating Random Sequence
|
|
|
Method of Concealment
|
|
|
Blinding/Masking
|
|
|
Primary Outcome
|
| Outcome |
TimePoints |
To assess the colour, coating & fissure,
shape/size, texture, types of movements of the
tongue in the healthy individuals and in patients
of Ashmari vikara (Urolothiasis) |
Baseline |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
To assess the colour, coating & fissure,
shape/size, texture, types of movements of the
tongue in the healthy individuals & in patients
of Ashmari vikara (Urolothiasis) And to use the collected data for upgradation of mobile Application |
18 Months |
|
|
Target Sample Size
|
Total Sample Size="151"
Sample Size from India="151"
Final Enrollment numbers achieved (Total)= "302"
Final Enrollment numbers achieved (India)="302" |
|
Phase of Trial
|
N/A |
|
Date of First Enrollment (India)
|
05/05/2024 |
| Date of Study Completion (India) |
15/07/2025 |
| Date of First Enrollment (Global) |
Date Missing |
| Date of Study Completion (Global) |
Date Missing |
|
Estimated Duration of Trial
|
Years="1"
Months="6"
Days="0" |
|
Recruitment Status of Trial (Global)
|
Not Applicable |
| Recruitment Status of Trial (India) |
Completed |
Publication Details
Modification(s)
|
This study Article submited in Scopus indexed journal and acceptance letter received. |
|
Individual Participant Data (IPD) Sharing Statement
|
Will individual participant data (IPD) be shared publicly (including data dictionaries)?
Response - NO
|
Brief Summary
Modification(s)
|
The Aim of This Study To Analyse Jihwa Variations in patients of Ashmari Vikara w.s.r. to Urolithiasis. The Objective To study changes in Jihwa manifested in Healthy
individuals and in patients of Ashmari Vikara. |