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CTRI Number  CTRI/2024/11/077363 [Registered on: 26/11/2024] Trial Registered Prospectively
Last Modified On: 07/11/2024
Post Graduate Thesis  Yes 
Type of Trial  Observational 
Type of Study   Cross Sectional Study 
Study Design  Other 
Public Title of Study   To assess the correlation between Jihwa Pariksha and Diabetes mellitus  
Scientific Title of Study   An observational study to assess the applicability of Jihwa Pariksha to determine the doshik predominance in subjects of Diabetes mellitus 
Trial Acronym  NIL 
Secondary IDs if Any  
Secondary ID  Identifier 
NIL  NIL 
 
Details of Principal Investigator or overall Trial Coordinator (multi-center study)  
Name  Madhav Sharma  
Designation  PG Scholar 
Affiliation  Shri Dhanwantry Ayurvedic College and Hospital Sector 46b, Chandigarh 
Address  A-107 Department of Rog nidan evum Vikriti vigyan Shri Dhanwantry Ayurvedic College and Hospital Chandigarh

Chandigarh
CHANDIGARH
160047
India 
Phone  9877170981  
Fax    
Email  maadhav009@gmail.com  
 
Details of Contact Person
Scientific Query
 
Name  Dr. Dolly Thakur 
Designation  Associate Professor  
Affiliation  Shri Dhanwantry Ayurvedic College and Hospital Sector 46b, Chandigarh 
Address  A-107 Department of Rog nidan evum Vikriti vigyan Shri Dhanwantry Ayurvedic College and Hospital Chandigarh

Chandigarh
CHANDIGARH
160047
India 
Phone  8284083577  
Fax    
Email  dolly.thakur7@gmail.com  
 
Details of Contact Person
Public Query
 
Name  Madhav Sharma  
Designation  PG Scholar 
Affiliation  Shri Dhanwantry Ayurvedic College and Hospital Sector 46b, Chandigarh 
Address  A-107 Department of Rog nidan evum Vikriti vigyan Shri Dhanwantry Ayurvedic College and Hospital Chandigarh


CHANDIGARH
160047
India 
Phone  9877170981  
Fax    
Email  maadhav009@gmail.com  
 
Source of Monetary or Material Support  
Laboratory of Shri Dhanwantry Ayurvedic College and Hospital Chandiagrh 160047 
 
Primary Sponsor  
Name  Dr. Madhav Sharma 
Address  A-107 Department of Rog nidan evum Vikriti vigyan  
Type of Sponsor  Other [self ] 
 
Details of Secondary Sponsor  
Name  Address 
NIL  NIL 
 
Countries of Recruitment     India  
Sites of Study  
No of Sites = 1  
Name of Principal Investigator  Name of Site  Site Address  Phone/Fax/Email 
Dr Madhav Sharma   Shri Dhanwantry Ayurvedic College and Hospital   A 107 Department of rog Nidan evum vikriti vigyan Shri Dhanwantry Ayurvedic College and Hospital
Chandigarh
CHANDIGARH 
9877170981

maadhav009@gmail.com 
 
Details of Ethics Committee  
No of Ethics Committees= 1  
Name of Committee  Approval Status 
INSTITUTIONAL ETHICS COMMITTEE SHRI DHANWANTRY AYURVEDIC COLLEGE AND HOSPITAL  Approved 
 
Regulatory Clearance Status from DCGI  
Status 
Not Applicable 
 
Health Condition / Problems Studied  
Health Type  Condition 
Patients  (1) ICD-10 Condition:E116||Type 2 diabetes mellitus with other specified complications. Ayurveda Condition: MADHUMEHAH/KSHAUDRAMEHAH,  
 
Intervention / Comparator Agent  
snoIntervention/ComparatorTypeDrug-TypeProcedure NameDetails
 
Inclusion Criteria  
Age From  10.00 Year(s)
Age To  60.00 Year(s)
Gender  Both 
Details  Known cases of type I diabetes mellitus (IDDM) & type II diabetes mellitus and patients with complications due to DM are also included.
Patients were screened irrespective of gender or socioeconomic status.
Patients between age group of 10-60 years are to be selected
Patients/Guardians who are able comprehend & willing to give consent and are able to adhere to SOPs of the study are to be included.
 
 
ExclusionCriteria 
Details  Patients with congenital anomalies of tongue, patients with any type of oral cavity trauma or any surgical intervention, affecting the tongue shape, size, texture are excluded
Patients having pan masala, betel, tobacco chewing habits and subjects with daily alcohol intake are excluded
Patients having local tongue infection, malignancies, patients on immunosuppressive drug therapy, patients undergoing chemotherapy, radiotherapy and chronic systemic bacterial infections (eg: Typhoid fever, Tuberculosis, etc.), gestational diabetes are to be excluded.
Patients diagnosed with HIV, Down’s syndrome, Klinefelter syndrome and other genetic disorders which may affect tongue in various manners
 
 
Method of Generating Random Sequence   Not Applicable 
Method of Concealment   Not Applicable 
Blinding/Masking   Not Applicable 
Primary Outcome  
Outcome  TimePoints 
To assess the applicability of Jihwa Pariksha in evaluating the dosha predominance in subjects of diagnosed Type-1 and Type-2 Diabetes mellitus  Baseline 
 
Secondary Outcome  
Outcome  TimePoints 
To correlate the clinical significance of Ayurvedic concepts of Jihwa Pariksha and DM and observe different manifestations according to doshas  Baseline 
 
Target Sample Size   Total Sample Size="400"
Sample Size from India="400" 
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)   01/01/2025 
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="3"
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  

An observational study to assess the applicability of Jihwa Pariksha to determine the doshik predominance in subjects of Diabetes mellitus

INTRODUCTION: In According to Ayurvedic principles, the tongue reflects the state of the body’s various system and overall health. The tongue’s colour, shape, size, texture, and coating can provide information about the doshas that govern the body. Tongue examination can be a part of the comprehensive assessment of a Diabetic patient done by an Ayurvedic practitioner. In Diabetes, the tongue’s appearance can provide information about the presence of imbalances in the body. In diabetes, Jihwa Pariksha can help to identify imbalances in the body’s doshas, which can help in early diagnosis and help in the formulation of personalized treatment plans according to doshik predominance.

LITERATURE REVIEW: As per Acharya Yogratnakara, change in characters/appearance of Tongue vitiated by Doshas:

जिह्वा शीता खरस्पर्शा स्फुटिता मारुतेऽधिके । रक्ता श्यामा भवेत्पित्ते कफे शुभ्राऽतिपिच्छिला ||1

कृष्णा सकण्टका शुष्का संनिपाताधिके तु सा। मिश्रिते मिश्रिता ज्ञेया सर्वलक्षणवर्जिता à¥¥à¥¨

AIMS: To study and assess doshik predominance in Jihwa by the aid of Jihwa Pariksha in subjects of Diabetes mellitus.

Primary objective: To assess the applicability of Jihwa Pariksha in evaluating the dosha predominance in subjects of diagnosed Type-1 and Type-2 Diabetes mellitus.

Secondary objective: To correlate the clinical significance of Ayurvedic concepts of Jihwa Pariksha and DM and observe different manifestations according to doshas.

NEED FOR THE STUDY:

The level of excellence in Jihwa Pariksha is starting to decline gradually and nowadays Jihwa Pariksha is meant for assessing the state of digestion alone. So, it is my attempt to study the observations and manifestations seen in Jihwa due to DM to facilitate easy diagnosis according to dosha predominance which will sequentially provide better management of the disease. This database may be helpful in further studies in the same subjects prophylactically and clinically.

MATERIALS AND METHODS: An observational study will be done on 400 patients. Subjects desired for the study will be taken from OPD &IPD of Shri Dhanwantry Ayurvedic College and Hospital, Chandigarh and associated institutes will be screened. Patients fulfilling the following diagnostic and inclusion criteria will be included. Diagnosis will be made on the basis of laboratory investigation to confirm the diagnosis of diabetes mellitus. An image acquisition device will used for the collection of tongue images developed by CSIR-CSIO, Chandigarh

STATISTICAL ANALYSIS:

Data will be collected using case report form (CRF) designed by incorporating all aspects (Ayurveda & modern medicine) for the study. Descriptive statistics will be computed to understand the central tendencies and variabilities within each group. Continuous data will be analysed using parametric test like t- test, Z-test, Karl Pearson’s correlation coefficient as and when required. Nominal & ordinal data will be analysed using nonparametric tests like spearman’s rank correlation, Kendall’s tau correlation coefficient, Mann-Whitney U test. SPSS will serve as the primary analysis tool, supplemented by Python and R. The changes with p value<0.05 will be considered as statistically significant. We will utilize Al-enhanced capabilities in power BI and Tableau for advanced Statistical analysis and data Visualization.

 
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