| CTRI Number |
CTRI/2023/06/054508 [Registered on: 27/06/2023] Trial Registered Prospectively |
| Last Modified On: |
26/06/2023 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Observational |
|
Type of Study
|
Cross Sectional Study |
| Study Design |
Other |
|
Public Title of Study
|
Observational study of tongue in individuals having different body constitute. |
|
Scientific Title of Study
|
An observational study to explore jivha in different deha prakriti. |
| Trial Acronym |
|
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Swarali Lahu Waghule |
| Designation |
MD Scholar |
| Affiliation |
MAMs Sumatibhai Shah Ayurved Mahavidyalaya |
| Address |
Department of Kriya Sharir MAMs Sumatibhai Shah Ayurved Mahavidyalaya Malwadi Hadapsar Pune 28
Pune
MAHARASHTRA
411028
India |
| Phone |
8806568583 |
| Fax |
|
| Email |
swaraliwaghule@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Abhijit V Chitnis |
| Designation |
Associate Professor |
| Affiliation |
MAMs Sumatibhai Shah Ayurved Mahavidyalaya |
| Address |
Department of Kriya Sharir MAMs Sumatibhai Shah Ayurved Mahavidyalaya Malwadi Hadapsar Pune 28
Pune
MAHARASHTRA
411028
India |
| Phone |
9822354577 |
| Fax |
|
| Email |
abhijitchitnis692@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Swarali Lahu Waghule |
| Designation |
MD Scholar |
| Affiliation |
MAMs Sumatibhai Shah Ayurved Mahavidyalaya |
| Address |
Department of Kriya Sharir MAMs Sumatibhai Shah Ayurved Mahavidyalaya Malwadi Hadapsar Pune 28
Pune
MAHARASHTRA
411028
India |
| Phone |
8806568583 |
| Fax |
|
| Email |
swaraliwaghule@gmail.com |
|
|
Source of Monetary or Material Support
|
| Department Of Kriya Sharir MAMs Sumatibhai Shah Ayurved Mahavidyalaya Hadapsar Pune 28 |
|
|
Primary Sponsor
|
| Name |
Swarali Lahu Waghule |
| Address |
Department Of Kriya Sharir MAMs Sumatibhai Shah Ayurved Mahavidyalaya Malwadi Hadapsar Pune 28 |
| 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 |
| Swarali Lahu Waghule |
MAMs Sumatibhai Shah Ayurved Mahavidyalaya Hadapsar Pune 28 |
Department Of Kriya Sharir MAMs Sumatibhai Shah Ayurved Mahavidyalaya Hadapsar Pune 28
Pune
MAHARASHTRA |
8806568583
swaraliwaghule@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| MAMs Sumatibhai Shah Ayurveda Mahavidyalaya And Sane Guruji Arogya Kendra Malwadi Hadapsar Pune 28 |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Healthy Human Volunteers |
Apparently Healthy Volunteers |
|
|
Intervention / Comparator Agent
|
| sno | Intervention/Comparator | Type | Drug-Type | Procedure Name | Details |
|
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
25.00 Year(s) |
| Gender |
Both |
| Details |
Apparently healthy volunteers in pune city will be included in the study of age between 18 to 25 years, who willing for participation in the project. |
|
| ExclusionCriteria |
| Details |
Apparently healthy volunteers in pune city not willing to participate in the study. Volunteers having Previous history of disorders of jihva, Any major systemic disorders, Major disorders of teeth and gums, Habit of smoking,chewing tobacco/gutka. |
|
|
Method of Generating Random Sequence
|
Not Applicable |
|
Method of Concealment
|
Not Applicable |
|
Blinding/Masking
|
Not Applicable |
|
Primary Outcome
|
| Outcome |
TimePoints |
1)To carry out conceptual study of Jihva and Prakriti from Brihottrayiee, Laghuttrayiee and Commentaries.
2)To assess the Prakriti of individual.
3)To assess the Jihva by validated Questionnaire and Modern parameters
I)Pallor grading scale
II)CODS grading score
III)Lee coating index score
IV)Mallampati classification score. |
08 Months |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| NIL |
NIL |
|
|
Target Sample Size
|
Total Sample Size="180"
Sample Size from India="180"
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)
|
06/07/2023 |
| 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="0"
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
|
This is an observational study to explore jihva in different deha prakriti, where the screening of individuals will be done on the basis of vata, pitta and kapha pradhan deha prakriti. After that jihva will be examined with the help of Ayurvedic questionnaire and modern parameters. As In Ayurveda for the purpose of Swastha and Aatur pariksha, prakriti pariksha is described in detail. Also it is important tool to diagnose the state of health in a healthy or a diseased person. Prakriti pariksha is a blue print of doshaj status of human body. Thus the imprints of dosha on most of the parts of body are explained in Prakriti pariksha by different Acharya’s. In this Prakriti pariksha list of organs jivha is not mentioned clearly. As Acharya Yogratnakar has given importance to jivha pariksha in Rogi Pariksha and has described doshaj imprint of jivha pariksha. Therefore it is important to examine the jivha in different deha Prakriti individuals. |