| CTRI Number |
CTRI/2025/03/083150 [Registered on: 24/03/2025] Trial Registered Prospectively |
| Last Modified On: |
06/03/2025 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Observational |
|
Type of Study
|
Case Control Study |
| Study Design |
Other |
|
Public Title of Study
|
Tongue examination in patients of Amlapitta - An observational study |
|
Scientific Title of Study
|
An observational study of Jihwa Pariksha in Amlapitta Vikara with special reference to Non-Ulcer Dyspepsia |
| 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 Prince N Bhalodia |
| Designation |
PG Scholar |
| Affiliation |
Parul Institute of Ayurved |
| Address |
Department of PG and Ph.D studies in Roga Nidana Evum Vikriti Vighyan ,Parul Institute of Ayurveda ,Parul University ,P.O. Limda ,Tal. Waghodia, Dist. Vadodara. Vadodara Gujarat 391760 India
Vadodara
GUJARAT
391760
India |
| Phone |
9638901116 |
| Fax |
|
| Email |
princebhalodia7@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Sachin Deva |
| Designation |
Professor and HOD |
| Affiliation |
Parul Institute of Ayurved |
| Address |
Department of PG and Ph.D studies in Roga Nidana Evum Vikriti Vighyan ,Parul Institute of Ayurveda ,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 Prince N Bhalodia |
| Designation |
PG Scholar |
| Affiliation |
Parul Institute of Ayurved |
| Address |
Department of PG and Ph.D studies in Roga Nidana Evum Vikriti Vighyan ,Parul Institute of Ayurveda ,Parul University ,P.O. Limda ,Tal. Waghodia, Dist. Vadodara. Vadodara Gujarat 391760 India
Vadodara
GUJARAT
391760
India |
| Phone |
9638901116 |
| Fax |
|
| Email |
princebhalodia7@gmail.com |
|
|
Source of Monetary or Material Support
|
| Parul Institute of Ayurved, P.O.Limda,Taluka-Waghodia, Dist -Vadodara,Pincode -391760 Gujarat |
|
|
Primary Sponsor
|
| Name |
Parul Institute of Ayurved |
| Address |
Department of PG and Ph.D studies in Roga Nidana Evum Vikriti Vighyan ,Parul Institute of Ayurveda ,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 Prince N Bhalodia |
1)Parul Institute of Ayurved 2)Khemdas Ayurved Hospital 3)Parul Sevashram Hospital 4)Camp |
OPD ward no. 7 and 105(Department of Panchkarma), 8 and 116 (Department of Kayachikitsa) IPD ward no. 201, 203, 205, 301, 302 (Department of Kayachikitsa and Panchkarma) Parul Ayurved Hospital, Parul University, P.O. Limda, Tal. Waghodia, Dist. Vadodara, Gujarat.
Vadodara
GUJARAT |
9638901116
princebhalodia7@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:K00-K95||Diseases of the digestive system. Ayurveda Condition: AMLAPITTAM, |
|
|
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 |
1)Selection of patients or healthy individuals will be done irrespective of socioeconomic status.
2)The healthy individuals between the age of 18 to 60 years will be taken for study in group A (control group).
3)The diagnosed patient with Lakshanas of Amlapitta(Non-Ulcer Dyspepsia)between the age of 18 to 60 years will be included in group B(Test group). |
|
| ExclusionCriteria |
| Details |
1) Patients with local tongue infection and congenital anomalies will be exclued.
2) Patient having major ailments of other systems.E.g.Carcinoma of any organ,Pregnancy,Hepatitis B,Hepatitis C,AIDS at the time of enrolling the patient. |
|
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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 Amlapitta Vikara(Non-Ulcer Dyspepsia). |
4 Weeks |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| Use the collected data for upgradation of mobile application |
18 Months |
|
|
Target Sample Size
|
Total Sample Size="300"
Sample Size from India="300"
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)
|
25/04/2025 |
| 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
|
The aim of this study is to conduct Jihwa Pariksha in Healthy individuals and in patient of Amlapitta Vikara with special reference to Non-Ulcer Dyspepsia.The objectives are to study the changes in Jihwa manifested in Healthy individuals and in patients of Amlapitta Vikara with Special reference to Non-Ulcer Dyspepsia.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 previous work there is some significant changes were found in color, coating, fissure in Amlapitta Vikara. So, for further changes want to seen in Amlapitta Vikara in Jihwa conduct this study. |