| CTRI Number |
CTRI/2018/05/014264 [Registered on: 31/05/2018] Trial Registered Prospectively |
| Last Modified On: |
25/11/2019 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Observational |
|
Type of Study
|
Cross Sectional Study |
| Study Design |
Single Arm Study |
|
Public Title of Study
|
Assessment of Heart diseases. |
|
Scientific Title of Study
|
A cross sectional study on the assessment of Heart ailment |
| Trial Acronym |
|
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Dr Hitha Shyam M S |
| Designation |
Pg scholar |
| Affiliation |
National institute of siddha |
| Address |
Department of maruthuvam
National institute of siddha
Tambaram sanatorium
Chennai
Kancheepuram
TAMIL NADU
600047
India |
| Phone |
8610774064 |
| Fax |
|
| Email |
hithashyam1@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr T Lakshmikantham |
| Designation |
Lecturer |
| Affiliation |
National institute of siddha |
| Address |
Department of maruthuvam
National institute of siddha
Tambaram sanatorium
Chennai
Kancheepuram
TAMIL NADU
600047
India |
| Phone |
9444466880 |
| Fax |
|
| Email |
drlakshmiramaswamy@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Dr Hitha Shyam M S |
| Designation |
Pg scholar |
| Affiliation |
National institute of siddha |
| Address |
Department of maruthuvam
National institute of siddha
Tambaram sanatorium
Chennai
Kancheepuram
TAMIL NADU
600047
India |
| Phone |
8610774064 |
| Fax |
|
| Email |
hithashyam1@gmail.com |
|
|
Source of Monetary or Material Support
|
| National institute of siddha
Tambaram sanatorium |
|
|
Primary Sponsor
|
| Name |
Ayothidoss pandithar hospital |
| Address |
National institute of siddha
Tambaram sanatorium
Chennai 600047 |
| Type of Sponsor |
Research institution and hospital |
|
|
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 Hitha Shyam M S |
Ayothidoss pandithar hospital |
Department of Maruthuvam
National institute of siddha
Tambaram sanatorium
Chennai 600047
Kancheepuram
TAMIL NADU |
8610774064
hithashyam1@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Institutional ethics committee |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
Health Condition / Problems Studied
Modification(s)
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition: I257||Atherosclerosis of coronary arterybypass graft(s) and coronary artery of transplanted heart with angina pectoris, (2) ICD-10 Condition: I251||Atherosclerotic heart disease of native coronary artery, Heart ailments, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Intervention |
Nil |
Nil |
|
|
Inclusion Criteria
|
| Age From |
20.00 Year(s) |
| Age To |
80.00 Year(s) |
| Gender |
Both |
| Details |
The patients with heart ailment
The patients who have the reports of ECG and Echocardiogram |
|
| ExclusionCriteria |
| Details |
Patients who do not have the reports of ECG and Echocardiogram |
|
|
Method of Generating Random Sequence
|
Not Applicable |
|
Method of Concealment
|
Not Applicable |
|
Blinding/Masking
|
Not Applicable |
|
Primary Outcome
|
| Outcome |
TimePoints |
| Analyze the predisposing factors of heart ailments and enhance the quality of life, treatment and life style |
Zeroth day |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| To enhance the quality of treatment and life style of cardiac patients. |
Zeroth day |
|
|
Target Sample Size
|
Total Sample Size="100"
Sample Size from India="100"
Final Enrollment numbers achieved (Total)= "100"
Final Enrollment numbers achieved (India)="100" |
|
Phase of Trial
|
N/A |
|
Date of First Enrollment (India)
|
04/06/2018 |
| Date of Study Completion (India) |
14/09/2018 |
| Date of First Enrollment (Global) |
Date Missing |
| Date of Study Completion (Global) |
Date Missing |
|
Estimated Duration of Trial
|
Years="0"
Months="3"
Days="0" |
Recruitment Status of Trial (Global)
Modification(s)
|
Not Applicable |
| Recruitment Status of Trial (India) |
Completed |
Publication Details
Modification(s)
|
published in Journal of Research in Biomedical Sciences (JRBMS)
A Peer reviewed Indexed International Journal (IF 0.92)
An Official Publication of BioSci Group of Research
|
|
Individual Participant Data (IPD) Sharing Statement
|
Will individual participant data (IPD) be shared publicly (including data dictionaries)?
|
Brief Summary
Modification(s)
|
This is a Cross-sectional study (Hospital Based) conducted at Ayothidoss Pandithar Hospital, National Institute of Siddha, Thambaram Sanatorium, Chennai 47. 100 heart patients who are belong to the age of 14- 80 years were included by checking their health
records such as ECG, Echocardiogram and Angiogram. The evaluation was based on the questionnaire about patient’s personal
history, such as food habits, level of stress, sleep rhythm, exercise, disease history, family history, occupational history and socioeconomic status and also by checking their medical records such as ECG, Echocardiogram and Angiogram. It was approved with the
NIS/IEC/2018/1, 07-05-2018 and analysed using STATA. Out of 100 patients61% of people come under the age
category of 51-70, and about 71% are males. 47% of
patients has normal BMI, 97% of them are married.
30% of patients are in desk work is the trending pattern
of occupation.
Another significant finding is 55% of patients are middle class, 85% are non-vegetarians. 56% members not
go for outside food, 55% patients doing exercise regularly. The percentage of people used to smoke, drinking
alcohol having drugs are low that is 16% and 13% respectively. Sleeping disturbance commonly seen in
65% of peoples. After checking the disease histories
55% are diabetic, 39% are hypertensive, 31% are hyperlipidemia and 43% are obese. We can find 5% Peoples
having congenital heart disease and 27% with hereditary pattern. Among different types of heart ailments
coronary heart disease occurs with maximum number of
88%. During the period of 2017-2018 there are 29% of
patients develops heart ailment.
Out of 88 Coronary Artery Disease patients 54 are
Diabetic, 38 are Hypertensive, 29 are Hyperlipidaemia,
41 are obese, and 74 are non-vegetarian.
Out of 100% of patients analysed there is only one
patient each in vegetarian and non-vegetarian having
Coronary Artery Disease without any past history of
diabetic, hypertension, hyperlipidaemia, obesity and
without the habit of alcoholic, smoking and drug abuse,
the both patients are keep doing exercise regularly
( table 3). By analysing ECG ST-T changes is 22% and
T wave elevation or depression is 40%. In this study
inferior wall MI is more than other walls of heart that is
33.3%. In angiogram LAD is more blocked (76.19%).
100% blocks are marked in RAC. In this study we can find patients are seeking treatment
in siddha system for their heart ailment, in which more
are males. Heart ailment is not only occurring through
one habit or life style, one disease history likes diabetes
or hypertension or hyperlipidemia but it is a result of
combined history of that patient. We just try to avoid
getting more weight and rid of diabetes mellitus. Most
of the patients are find out their heart problem recently
and they are come to this hospital for avoiding surgery
and lifelong medication. |