| 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
|
|
|
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
|
|
|
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
|
| sno | Intervention/Comparator | Type | Drug-Type | Procedure Name | Details |
|
|
|
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:
जिहà¥à¤µà¤¾ शीता खरसà¥à¤ªà¤°à¥à¤¶à¤¾ सà¥à¤«à¥à¤Ÿà¤¿à¤¤à¤¾ मारà¥à¤¤à¥‡à¤½à¤§à¤¿à¤•े । रकà¥à¤¤à¤¾ शà¥à¤¯à¤¾à¤®à¤¾ à¤à¤µà¥‡à¤¤à¥à¤ªà¤¿à¤¤à¥à¤¤à¥‡ कफे शà¥à¤à¥à¤°à¤¾à¤½à¤¤à¤¿à¤ªà¤¿à¤šà¥à¤›à¤¿à¤²à¤¾ ||1
कृषà¥à¤£à¤¾ सकणà¥à¤Ÿà¤•ा शà¥à¤·à¥à¤•ा संनिपाताधिके तॠसा। मिशà¥à¤°à¤¿à¤¤à¥‡ मिशà¥à¤°à¤¿à¤¤à¤¾ जà¥à¤žà¥‡à¤¯à¤¾ सरà¥à¤µà¤²à¤•à¥à¤·à¤£à¤µà¤°à¥à¤œà¤¿à¤¤à¤¾ ॥२
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. |