| CTRI Number |
CTRI/2025/03/082671 [Registered on: 18/03/2025] Trial Registered Prospectively |
| Last Modified On: |
12/03/2025 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Observational |
|
Type of Study
|
Case Control Study |
| Study Design |
Other |
|
Public Title of Study
|
Observing Tongue Changes in Jaundice Patients |
|
Scientific Title of Study
|
An Observational Study Of Jihwa Pariksha In Kamala With Special Reference To Jaundice |
| 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 Arpita Yadav |
| Designation |
PG Scholar |
| Affiliation |
Parul Institute of Ayurved |
| Address |
Department Of PG and Ph.D. Studies in Roga Nidan Evum Vikriti Vigyan, Parul Institute of Ayurved, Parul University, P.O. Limbda, Tal. Waghodia
Vadodara
GUJARAT
391760
India |
| Phone |
9752412980 |
| Fax |
|
| Email |
drarpitayadav@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Mrunal Bhoir |
| Designation |
Associate Professor |
| Affiliation |
parul institute of ayurved |
| Address |
Department Of PG and Ph.D. Studies in Roga Nidan Evum Vikriti Vigyan, Parul Institute of Ayurved, Parul University, P.O. Limbda, Tal. Waghodia
Vadodara
GUJARAT
391760
India |
| Phone |
8793488139 |
| Fax |
|
| Email |
mrunal.bhoir24537@paruluniversity.ac.in |
|
Details of Contact Person
Public Query
|
| Name |
Dr Arpita Yadav |
| Designation |
PG scholar |
| Affiliation |
parul institute of ayurved |
| Address |
Department Of PG and Ph.D. Studies in Roga Nidan Evum Vikriti Vigyan, Parul Institute of Ayurved, Parul University, P.O. Limbda, Tal. Waghodia
Vadodara
GUJARAT
391760
India |
| Phone |
9752412980 |
| Fax |
|
| Email |
drarpitayadav@gmail.com |
|
|
Source of Monetary or Material Support
|
| Parul Institute Of Ayurved,P.O Limda,Tal.Waghodia ,Dist. Vadodara,Pincode - 391760,Gujrat,India. |
|
|
Primary Sponsor
|
| Name |
Parul Institute of Ayurved |
| Address |
Department Of PG and Ph.D. Studies in Roga Nidan Evum Vikriti Vigyan, Parul Institute of Ayurved, Parul University, P.O. Limbda, Tal. Waghodia. |
| 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 Arpita Yadav |
Parul institute of ayurved |
Department Of PG and Ph.D. Studies in Roga Nidan Evum Vikriti Vigyan, Parul Institute of Ayurved, Parul University, P.O. Limbda, Tal. Waghodia.
Vadodara
GUJARAT |
9752412980
drarpitayadav@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Institutional ethics committee ,Parul Institute of Ayurved |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition:K77||Liver disorders in diseases classified elsewhere. Ayurveda Condition: KAMALA, |
|
|
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 |
Patients irrespective of their gender, occupation, religion, socio-economic status
will be selected.
The diagnosed patients of Kamala with mentioned criterias will be taken between
the age of 18-60 years. |
|
| ExclusionCriteria |
| Details |
Patients with local tongue infection (oral lichen planus, oral thrush etc) and
congenital anomalies will be excluded.
The patient having major ailments of other systems IDS, CA of any organs,
Pregnancy ,TB 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 and fissure, shape/size, texture, type of movement of tongue in healthy individuals and in the patients of Kamala w.s.r Jaundice |
observation will done on 1st day total 18 months study . no follow up as its an observational study |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| To use the collected data for upgradation of mobile application |
18 months |
|
|
Target Sample Size
|
Total Sample Size="200"
Sample Size from India="200"
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)
|
16/04/2025 |
| 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="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
|
Conducting systematic studies on Jihwa Pariksha in Kamala can contribute to the
growing body of evidence supporting the efficacy and validity of Ayurvedic
diagnostic techniques. By employing rigorous research methodologies and
observational studies, researchers can elucidate the diagnostic accuracy and clinical
utility of Jihwa Pariksha in the context of Kamala. Jihwa Pariksha offers a non-invasive and cost-effective method for diagnosing
Kamala. By examining the tongue’s color, texture, coating, and moisture content,
practitioners can identify subtle manifestations of dosha imbalance, providing
valuable diagnostic insights. Kamala, if left untreated, can progress to severe liver dysfunction and complications.
Through Jihwa Pariksha, early signs of bilirubin dysregulation and hepatic
impairment can be detected, enabling prompt intervention and mitigating the risk of
disease progression. By correlating findings from Jihwa Pariksha with Ayurvedic principles, practitioners
can formulate personalized treatment plans aimed at addressing the root cause of
Kamala and restoring doshas equilibrium. Systematic research on Jihwa Pariksha in Kamala can add to the increasing amount of
data demonstrating the reliability and effectiveness of Ayurvedic diagnostic methods. If kamala is not treated, serious liver problems and malfunction may develop. Early
detection of bilirubin dysregulation and hepatic impairment is made possible by Jihwa
Pariksha, which reduces the chance of illness progression and allows for timely
intervention. Through the use of Ayurvedic concepts to Jihwa Pariksha results, practitioners can
create customized treatment strategies that target the underlying cause of Kamala and
restore dosha equilibrium. |