| CTRI Number |
CTRI/2024/10/076091 [Registered on: 30/10/2024] Trial Registered Prospectively |
| Last Modified On: |
17/10/2024 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Observational |
|
Type of Study
|
clinical diagnostic study |
| Study Design |
Single Arm Study |
|
Public Title of Study
|
Diagnosis of Heart Attack through Electrocardiogram(ECG) |
|
Scientific Title of Study
|
A Diagnostic study on kaphaja hridroga (Myocardial Infarction) |
| 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 Shashank T P |
| Designation |
Post Graduation ( Roga Nidana Evum Vikriti Vigyan) |
| Affiliation |
Alvas Ayurveda Medical College and Hospital Vidyagiri Moodbidre |
| Address |
Alvas Ayurveda Medical College and Hospital,Vidyagiri, moodubidre
Dakshina Kannada
Dakshina Kannada
KARNATAKA
574227
India |
| Phone |
8123675910 |
| Fax |
|
| Email |
shashanktpsuguru@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Prashanth Jain |
| Designation |
Head of the Department and Professor of Department of Roga Nidana Evum Vikriti Vigyan |
| Affiliation |
Alvas Ayurveda Medical College and Hospital Vidyagiri Moodbidre |
| Address |
Alvas Ayurveda Medical College and Hospital,Vidyagiri, moodubidre
Dakshina Kannada
Dakshina Kannada
KARNATAKA
574227
India |
| Phone |
9901327241 |
| Fax |
|
| Email |
drprashanthjain@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Dr Prashanth Jain |
| Designation |
Head of the Department and Professor |
| Affiliation |
Alvas Ayurveda Medical College and Hospital Vidyagiri Moodbidre |
| Address |
Alvas Ayurveda Medical College and Hospital,Vidyagiri, moodubidre
Dakshina Kannada
Dakshina Kannada
KARNATAKA
574227
India |
| Phone |
9901327241 |
| Fax |
|
| Email |
drprashanthjain@gmail.com |
|
|
Source of Monetary or Material Support
|
| Alvas Ayurveda Medical College and Hospital Vidyagiri Moodbidre 574227 |
|
|
Primary Sponsor
|
| Name |
Dr Shashank T P |
| Address |
Alvas Ayurveda Medical College and Hospital Vidyagiri Moodbidre 574227 |
| 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 Shashank T P |
Alvas Ayurveda Medical College & Hospital Moodbidire |
Department of PG studies in Roganidana & Vikriti vigyan Alvas Ayurveda Hospital And Alvas Health Centre
Dakshina Kannada
KARNATAKA |
08123675910
shashanktpsuguru@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Institutional Ethical Committee, Alvas Ayurveda Medical College and Hospital |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition:I219||Acute myocardial infarction, unspecified. Ayurveda Condition: HRUDROGAH, |
|
|
Intervention / Comparator Agent
|
| sno | Intervention/Comparator | Type | Drug-Type | Procedure Name | Details |
|
|
|
Inclusion Criteria
|
| Age From |
20.00 Year(s) |
| Age To |
70.00 Year(s) |
| Gender |
Both |
| Details |
1. Patients will be selected accordingly who fulfills the diagnostic criteria.
2. Patients between age group 20-70 years of both sexes.
3.Patients with clinical features of kaphaja hridroga |
|
| ExclusionCriteria |
| Details |
Patients of congenital heart disease.
Pregnant women
Patients suffering from other systemic disorders
Non cardiac conditions of chest pain |
|
|
Method of Generating Random Sequence
|
|
|
Method of Concealment
|
|
|
Blinding/Masking
|
|
|
Primary Outcome
|
| Outcome |
TimePoints |
| Based on the Doshic involvement in pathogenesis of Hridroga, classical lakshanas of kaphaja Hridroga and ECG changes were studied in all the subjects. |
at baseline-Till Clinical and ECG Evaluation of patients of Acute Myocardial Infarction since it is a observational clinical study. |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| Possible corelation of kaphaja hridroga to specific ecg pattern |
at baseline-Till Clinical & ECG Evaluation of patients of Acute Myocardial Infarction |
|
|
Target Sample Size
|
Total Sample Size="30"
Sample Size from India="30"
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)
|
01/11/2024 |
| 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 Yet Recruiting |
| 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
|
Observation Clinical Considering the increasing incidence of Coronary Artery Diseases, early
diagnosis is the key in preventing the fatal outcomes.
The easily available and most relevant investigation is Electrocardiogram (ECG) – serves as the first-line
diagnostic tool apt for the diagnosis of Acute Coronary Syndrome (ACS) .
Hence in my study attempt is made to understand Kaphaja Hridroga /
Myocardial Infarction and diagnosing it with the help of ECG findings. |