| CTRI Number |
CTRI/2025/03/082291 [Registered on: 13/03/2025] Trial Registered Prospectively |
| Last Modified On: |
12/03/2025 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Observational |
|
Type of Study
|
Cross Sectional Study |
| Study Design |
Other |
|
Public Title of Study
|
Fissured Tongue As An Diagnostic Tool in Vataj Hridroga - An Observational Study |
|
Scientific Title of Study
|
An Observational Study To Analyse The Association Of Sphutita Jihwa In Vataj Hridroga |
| 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 Sandeep Kumar |
| Designation |
PhD Scholar |
| Affiliation |
Desh Bhagat University |
| Address |
Faculty of Ayurveda, Department of Kayachikitsa, Room No. 201, Second Floor, Desh Bhagat University, Amloh Road, Mandi Gobindgarh, Distt. Fatehgarh Sahib
Fatehgarh Sahib
PUNJAB
147301
India |
| Phone |
9417944197 |
| Fax |
|
| Email |
dr.sandeepsaxena1980@yahoo.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr. Darshana |
| Designation |
Associate Professor |
| Affiliation |
Desh Bhagat University |
| Address |
Faculty of Ayurveda, Department of Kayachikitsa, Room No.201, Second Floor, Desh Bhagat University, Amloh Road, Mandi Gobindgarh, Distt. Fatehgarh Sahib
Fatehgarh Sahib
PUNJAB
147301
India |
| Phone |
9417944197 |
| Fax |
|
| Email |
dahiya.darshana222@yahoo.com |
|
Details of Contact Person
Public Query
|
| Name |
Dr Sandeep Kumar |
| Designation |
PhD Scholar |
| Affiliation |
Desh Bhagat University |
| Address |
Faculty of Ayurveda, Department of Kayachikitsa, Room No. 201, Second Floor, Desh Bhagat University, Amloh Road, Mandi Gobindgarh, Distt. Fatehgarh Sahib
Fatehgarh Sahib
PUNJAB
147301
India |
| Phone |
9417944197 |
| Fax |
|
| Email |
dr.sandeepsaxena1980@yahoo.com |
|
|
Source of Monetary or Material Support
|
| Desh Bhagat University, Faculty of Ayurveda, Department of Kayachikitsa, Amloh Road, Mandi Gobindgarh, Distt - Fatehgarh Sahib, Punjab, PIN - 147301 |
|
|
Primary Sponsor
|
| Name |
Desh Bhagat University |
| Address |
Faculty of Ayurveda, Amloh Road, Mandi Gobindgarh, Distt. Fatehgarh Sahib, Punjab - 147301 |
| 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 Sandeep Kumar |
Desh Bhagat University |
Faculty of Ayurveda, Room No.101, Kayachikitsa OPD, Department of Kayachikitsa Ground Floor, Desh Bhagat Ayurvedic Hospital, Desh Bhagat University, Amloh Road, Mandi Gobindgarh - 147301
Fatehgarh Sahib
PUNJAB |
9417944197
dr.sandeepsaxena1980@yahoo.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| UEC (University Ethics Committee) |
Approved |
|
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Regulatory Clearance Status from DCGI
|
|
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Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition:I259||Chronic ischemic heart disease, unspecified. Ayurveda Condition: HRUDROGAH, |
|
|
Intervention / Comparator Agent
|
| sno | Intervention/Comparator | Type | Drug-Type | Procedure Name | Details |
|
|
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Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
60.00 Year(s) |
| Gender |
Both |
| Details |
1.Selection of patients will be done irrespective of gender, socioeconomic
status.
2. Clinically diagnosed and confirmed patients of Vataj Hridroga will be
selected. |
|
| ExclusionCriteria |
| Details |
1. Patient with local tongue infection and congenital anomalies will be
excluded.
2. Patients having major ailments of other systems like Tuberculosis, Chronic
Renal Failure, Cancer, AIDS, Paralysis. |
|
|
Method of Generating Random Sequence
|
Not Applicable |
|
Method of Concealment
|
Not Applicable |
|
Blinding/Masking
|
Not Applicable |
|
Primary Outcome
|
| Outcome |
TimePoints |
| Jihwa Pariksha is one of the important examination tool mentioned in Ayurvedic Literature, but not backed by documented scientific research. No study has been done earlier regarding association of Sphutita Jihwa in Vataj Hridroga. So in this study an effort will be made to analyse the association of Sphutita Jihwa in Vataj Hridroga. |
18 Months |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| As this is an observational study and i am going to analyse the association of Sphutita Jihwa in Vataj Hridroga. There may some relation be found or there may be nothing significant findings. |
18 Months |
|
|
Target Sample Size
|
Total Sample Size="100"
Sample Size from India="100"
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)
|
24/03/2025 |
| 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="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 - YES
- What data in particular will be shared?
Response - All of the individual participant data collected during the trial, after de-identification.
- What additional supporting information will be shared?
Response - Study Protocol
Response - Statistical Analysis Plan
Response - Clinical Study Report
Response - Analytic Code
- Who will be able to view these files?
Response - Researchers who provide a methodologically sound proposal.
- For what types of analyses will this data be available?
Response - To achieve aims in the approved proposal.
- By what mechanism will data be made available?
Response - Proposals should be directed to [dr.sandeepsaxena1980@yahoo.com].
- For how long will this data be available start date provided 12-06-2026 and end date provided 12-06-2031?
Response - Beginning 3 months and ending 5 years following article publication.
- Any URL or additional information regarding plan/policy for sharing IPD?
Additional Information - NIL
|
|
Brief Summary
|
The description of Hridroga in Ayurveda is fairly brief, yet today, cardiovascular
illnesses are the most common serious conditions in industrialized nations and are a
rapidly expanding concern in developing countries.In Ayurvedic texts 107 number of
Marmas (vital organs) are mentioned, while Trimarmas i.e Basti (Urinary System),
Hridayam (Heart) and Shira (Head) are considered supreme among themselves,
because they possess Pran (Life force) in them. Among
these Trimarmas, Hridaya has its own importance as this is the seat of Chetna.
In Ayurveda, Jihwa Pariksha is an important assessment method that is thought to be
the simplest way to see changes occurring. In Hridroga there may be specific
manifestations on Jihwa, which further can be used as diagnostic criteria.
NEED FOR STUDY:
- Hridroga is one of most common found diseased entity clinically both as
lakshans in different disease as well as in the form independent disease.
- Jihwa Pariksha is one of the important examination tool mentioned in
Ayurvedic Literature, but not backed by documented scientific research.
- No study has been done earlier regarding Jihwa Pariksha in Vataj Hridroga.
So in this study an effort will be made to analyze the changes in Jihwa in
Hridroga and this work will be a unique contribution in Ayurveda
AIM & OBJECTIVES:
AIM :
- To Study the Association of Sphutita Jihwa in Vataj Hridroga.
OBJECTIVES :
- To study the Association of Sphutita Jihwa in Vataj Hridroga.
HYPOTHESIS:
Null Hypothesis (H0):
- There is no relation between Sphutita Jihwa and Vataj Hridroga
Alternate Hypothesis (H1):
- There is relation between Sphutita Jihwa and Vataj Hridroga.
RESEARCH QUESTION: Is there is any relation between Sphutita Jihwa and Vataj
Hridroga ?
Methods of collection of data
a. Study design
- Detailed history taking with along with physical examination will be carried
out.
- Clinically diagnosed and confirmed patients of Vataj Hridroga will be
selected as per inclusion criteria.
b. Type of study
Observational Study
c. Sampling technique
Purposive (Convenience Sampling)
d. Sample size
100 (Convenience Sampling)
Criteria for diagnosis:
Patients present with Lakshanas of Vataj Hridroga (Charak, Sushruta,
Vagbhata):
1. Vepathu (Impeded Working/Murmur)
2. Stambh (Bradycardia)
3. Pramoha (Confused state)
4. Hrutshyunyata (Emptiness in heart)
5. Dara (Palpitation)
6. Jirne atyarthe vedana (Post prandial pain)
7. Hrutshul (Chest pain) 8. Shulyate Atyarthe (Severe pain)
9. Shosha (Sense of dryness)
10. Drava (Tachycardia)
11. Aksmat Dinata (Fatigue)
12. Shwasavrodha (Dyspnea)
13. Shoka (Grief)
14. Bhaya (Fear)
15. Shabdasahihnuta (Intolerance to sound)
16. Alpanidra (Insomnia)
17. Stabdhata (Bradycardia)
Assessment of result
1. Subjective parameters
Classical Lakshanas of Vataj Hridroga will be assessed as per grading.
i. Objective parameters
Tongue will be physically examined by Darshan Pariksha as follows:
Grade Number of fissures on tongue surface
0 No fissure on tongue
1 Ranging from 1-3 in number
2 Ranging from 4-10 in numbers
3 More than 10 fissures
S.NO. Pattern of Tongue Fissure
1. Central Longitudinal Pattern
2. Central Transverse Pattern
3. Lateral Longitudinal Pattern
4. Branching Pattern
5. Diffuse Pattern
INVESTIGATIONS
• Jihwa Pariksha
STATISTICAL ANALYSIS
Result will be assessed with suitable standard statistical test.
ETHICAL CLEARANCE
The study will be approved by Institutional ethical committee.
DECLARATION
The study will be completed in the stipulated time.
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