| CTRI Number |
CTRI/2023/08/056260 [Registered on: 08/08/2023] Trial Registered Prospectively |
| Last Modified On: |
08/08/2023 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Observational |
|
Type of Study
|
Single Arm Study |
| Study Design |
Other |
|
Public Title of Study
|
An Observational and Analytical Study to Evaluate Heart Diseases with ECG,2D Echo and Fasting Lipid Profile |
|
Scientific Title of Study
|
An Observational and Analytical Study to Evaluate Doshaja Hridroga with ECG,2D Echo and Fasting Lipid Profile |
| 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 Kshitij Kumar Dubey |
| Designation |
PG Scholar |
| Affiliation |
Parul Institute of Ayurved |
| Address |
Department of PG & PhD studies in Roga Nidana Evum Vikriti Vigyana,Parul Institute of Ayurved,Parul University,P.O.Limda,Tal.waghodia,Dist.Vadodara,Gujarat
Vadodara
GUJARAT
391760
India |
| Phone |
7999153692 |
| Fax |
|
| Email |
kshitijdubey1@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Sachin Deva |
| Designation |
Professor |
| Affiliation |
Parul Institute of Ayurved |
| Address |
Department of PG & PhD studies in Roga Nidana Evum Vikriti Vigyana,Parul Institute of Ayurved,Parul University,P.O.Limda,Tal.waghodia,Dist.Vadodara,Gujarat
Vadodara
GUJARAT
391760
India |
| Phone |
9844810957 |
| Fax |
|
| Email |
sachin.deva@paruluniversity.ac.in |
|
Details of Contact Person
Public Query
|
| Name |
Dr Kshitij Kumar Dubey |
| Designation |
PG Scholar |
| Affiliation |
Parul Institute of Ayurved |
| Address |
Department of PG & PhD studies in Roga Nidana Evum Vikriti Vigyana,Parul Institute of Ayurved,Parul University,P.O.Limda,Tal.waghodia,Dist.Vadodara,Gujarat
Vadodara
GUJARAT
391760
India |
| Phone |
7999153692 |
| Fax |
|
| Email |
kshitijdubey1@gmail.com |
|
|
Source of Monetary or Material Support
|
|
|
Primary Sponsor
|
| Name |
Parul Institute of Ayurved |
| Address |
Department of PG & PhD studies in Roga Nidana Evum Vikriti Vigyana,Parul Institute of Ayurved,Parul University,P.O.Limda,Tal.waghodia,Dist.Vadodara,Gujarat |
| 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 Kshitij Kumar Dubey |
Parul Ayurved Hospital,Khemdas Ayurved Hospital,Parul Sevashram Hospital |
OPD NO 7& 105(Panchkarma),OPD NO 8 &116 (Kayachikitsa),IPD NO 201,203,205,301,302 (Kayachikitsa & Panchkarma),Medicine OPD NO 11,IPD NO 332,333,342,343,cardiology Opd no 11.6,CTVS opd no 11.7,ecg room no 11.8,echocardiography room no 12.3,Cardiac cath lab room no 338,cardiac icu & cardiac ot room no 339,Parul University,P.O.limda,Tal-Waghodia,Vadodara,Gujarat
Vadodara
GUJARAT |
7999153692
kshitijdubey1@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Institutional Ethics Committee, Parul Institute of Ayurved, Parul University |
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, (2) ICD-10 Condition:I019||Acute rheumatic heart disease, unspecified. Ayurveda Condition: HRUDROGAH, (3) ICD-10 Condition:I110||Hypertensive heart disease with heart failure. Ayurveda Condition: HRUDROGAH, (4) ICD-10 Condition:I209||Angina pectoris, unspecified. Ayurveda Condition: HRUDROGAH, (5) ICD-10 Condition:I798||Other disorders of arteries, arterioles and capillaries in diseases classified elsewhere. Ayurveda Condition: HRUDROGAH, (6) ICD-10 Condition:I089||Rheumatic multiple valve disease,unspecified. Ayurveda Condition: HRUDROGAH, |
|
|
Intervention / Comparator Agent
|
| sno | Intervention/Comparator | Type | Drug-Type | Procedure Name | Details |
|
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
55.00 Year(s) |
| Gender |
Both |
| Details |
1 Diagnosed cases of Heart Diseases like Angina and Myocardial Infarction, Heart Failure, Rheumatic Heart Disease, Cardiomyopathy, Congenital Heart Disease, Valvular Heart Disease, Carditis, Aortic aneurysms etc. patients with symptoms of Hridroga.
2 Patients diagnosed with post covid cardiac disorder.
3 Duration of disease – 0-10 yrs,10 - 20 yrs ,20 - 30 yrs,30-40 yrs. (with 10 years duration) |
|
| ExclusionCriteria |
| Details |
1 Patients diagnosed with symptoms of Krimaj Hridroga.
2 Patient having major ailments of other systems. Eg CA of any organs, Hepatitis B and C, Pregnancy, TB etc. at the time of enrolling the patients.
|
|
|
Method of Generating Random Sequence
|
Not Applicable |
|
Method of Concealment
|
Not Applicable |
|
Blinding/Masking
|
Not Applicable |
|
Primary Outcome
|
| Outcome |
TimePoints |
| As this is an Observational study & i am going to assess the relation between types of hridroga based on ECG, Echo & Fasting lipid profile with duration of disease.There may be some changes which i will get or there may be nothing significant finding. Here we are going to establish the relation in hridroga types on the basis of symptoms and investigations |
18 MONTH |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| As this is observational study I am going to observe the relation between the duration of onset of the study & its impact on the ECG & 2D echo & fasting lipid profile |
12 MONTHS |
|
|
Target Sample Size
|
Total Sample Size="185"
Sample Size from India="185"
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)
|
18/08/2023 |
| 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="6"
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
|
• Cardiovascular disease (CVD) is a class of diseases that involve the heart or blood vessels. CVD includes coronary artery diseases (CAD) such as angina and myocardial infarction (commonly known as a heart attack). Other CVDs include stroke, heart failure, hypertensive heart disease, rheumatic heart disease, cardiomyopathy, abnormal heart rhythms, congenital heart disease, valvular heart disease, carditis, aortic aneurysms, peripheral artery disease, thromboembolic disease, and venous thrombosis. As Cardiovascular diseases are occurring in early phase of life due to various etiological factors so to establish which type of Doshaj Hridroga is dominant in relation to chronicity of the disease and to find investigation changes in different types of hridaya roga so we can get early prevention, management and awareness regarding particular type of Doshaj Hridroga. Diagnosed case of hridroga/cardiac disorder will be enrolled for the study and classification will be done on the basis of doshaj hridroga lakshanas ,ecg,2D echo and Fasting Lipid Profile will be conducted and doshaj hridroga based on duration and investigations will be analyzed. |