| CTRI Number |
CTRI/2024/05/066838 [Registered on: 06/05/2024] Trial Registered Prospectively |
| Last Modified On: |
13/08/2025 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Observational |
|
Type of Study
|
Case Control Study |
| Study Design |
Other |
|
Public Title of Study
|
Examination Of Tongue In Rhinitis Patients - An Observational Study |
|
Scientific Title of Study
|
An Observational Study Of Jihwa Pariksha In Pratishyaya With Special Reference To Rhinitis |
| Trial Acronym |
JPPRHINITIS |
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Dr Komal Khengar |
| 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.Waghodiya, Dist.Vadodara
Vadodara
GUJARAT
391760
India
Vadodara
GUJARAT
391760
India |
| Phone |
9586121242 |
| Fax |
|
| Email |
drkomalkhengar@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Sachin Deva |
| Designation |
Professor |
| Affiliation |
Parul University 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.Waghodiya, 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 Sachin Deva |
| Designation |
Professor |
| Affiliation |
Parul University 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.Waghodiya, Dist.Vadodara
Vadodara
GUJARAT
391760
India
GUJARAT
391760
India |
| Phone |
9844810957 |
| Fax |
|
| Email |
sachin.deva@paruluniversity.ac.in |
|
|
Source of Monetary or Material Support
|
| PARUL UNIVERSITY, P.O. LIMDA, TAL. WAGHODIA, DIST. 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.Waghodiya, 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 Komal Khengar |
1. Parul Ayurved Hospital, 2. Khemdas Ayurved Hospital, 3. Parul Sevashram Hospital |
OPD ward No. 7 and 105 (Department Of Panchakarma), 8 And 116 (Department Of Kayachikitsa)
IPD ward No. 201, 203, 205, 301, 302 (Department Of Kayachikitsa and Panchakarma)
Department of PG & Ph.D.
Parul Institute Of Ayurved, Parul University, P.O.Limda, tal.Waghodiya.
Vadodara
GUJARAT |
9586121242
drkomalkhengar@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:J399||Disease of upper respiratory tract, unspecified. Ayurveda Condition: PRATISYAYAH/PINASAH, |
|
|
Intervention / Comparator Agent
|
| sno | Intervention/Comparator | Type | Drug-Type | Procedure Name | Details |
|
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
65.00 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 – 65 years will be included in group A (control group).
3.The diagnosed patients of Pratishyaya between 18 - 65 years will be included in group B (test group). |
|
| ExclusionCriteria |
| Details |
1.Patient with local tongue infection and congenital anomalies will be excluded.
2.Patients suffering from Respiratory diseases like Tuberculosis, Pneumonia, Nasal polyp, DNS, Ulceration of nasal mucous membrane, Mumps, Measles, Tumors of Nose, other infectious diseases associated with Pratishyaya, 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 asses the color, coating and fissure, shape/size, texture, type of movement of tongue in healthy individuals and in the patients of Pratishyaya (Rhinitis) |
4 Weeks |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| To use the collected data for upgradation of mobile application. |
18 months |
|
|
Target Sample Size
|
Total Sample Size="360"
Sample Size from India="360"
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)
|
16/05/2024 |
| 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)
Modification(s)
|
Not Yet Recruiting |
| Recruitment Status of Trial (India) |
Open to Recruitment |
|
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
|
The aim of the study is to conduct Jihwa Pariksha in Healthy individuals and in patients of Pratishyaya with special reference to Rhinitis. The objectives are to study the changes in Jihwa manifested in healthy individuals and in patients of Pratishyaya with special reference to Rhinitis. Need for the study - The appearance of our tongue is a reflection of our health, so it can be used as a powerful tool for diagnosis of the disease. By examining the tongue, one can infer not only the state of doshas, but certain conditions about the tissues and the organs also, along with presence of ama. The treatment excluding tongue is impossible as it is the first point where the digestion starts and there is no such type of study has been done regarding tongue as a diagnostic method. This study will give us the knowledge about the diagnosis of diseases. In India 15% of the population suffers from rhinitis, prevalence being increasing over past many years. No previous much work has been done till date regarding the study of Jihwa Pariksha in Pratishyaya. So its an effort to go through this particular topic and find out changes in the tongue in Pratishyaya . So that early diagnosis followed by prone treatment can be suggested. To understand the changes happening in Jihwa by its examination in Pratishyaya by machine learning technique in imaging. Tongue is a reflection of what is happening inside a body and it reflects the overall digestive, nutritive, and metabolic conditions of body. Tongue examination is an easy and indispensable part to know sama, nirama and vriddhi, kshaya awastha of dosha, finally in the diagnosis of disease. So for diagnosis of Pratishyaya the tongue examination can be very useful diagnostic tool. In this study, an effort will be made to analyze the changes in Jihwa due to Pratishyaya and this work will be unique contribution in Ayurveda. |