| CTRI Number |
CTRI/2024/05/067087 [Registered on: 09/05/2024] Trial Registered Prospectively |
| Last Modified On: |
07/05/2024 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Observational |
|
Type of Study
|
Cross Sectional Study |
| Study Design |
Other |
|
Public Title of Study
|
cardiovascular risk prediction as per prakriti |
|
Scientific Title of Study
|
DETERMINATION OF THE RISK PREDICTION OF CARDIOVASCULAR DISEASE AS PER PRAKRITI AMONG PATIENTS OF DIABETES MELLITUS type-2 |
| Trial Acronym |
|
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Dr Shubham Maharana |
| Designation |
PG Scholar |
| Affiliation |
Chaudhary Brahm Prakash Ayurved Charak Sansthan |
| Address |
PG Department of Kriyasharir, Chaudhary Brahm Prakash ayurved
Charak Sansthan, Khera Dabar South West DELHI 110073 India
South West
DELHI
110073
India
South West
DELHI
110073
India |
| Phone |
7008932094 |
| Fax |
|
| Email |
smaharana243@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Rakesh Roushan |
| Designation |
Assistant Professor |
| Affiliation |
Chaudhary Brahm Prakash Ayurved Charak Sansthan |
| Address |
PG Department of Kriyasharir, Chaudhary Brahm Prakash ayurved
Charak Sansthan, Khera Dabar South West DELHI 110073 India
South West
DELHI
110073
India
South West
DELHI
110073
India |
| Phone |
9136226421 |
| Fax |
|
| Email |
rakesh3151@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Dr Rakesh Roushan |
| Designation |
Assistant Professor |
| Affiliation |
Chaudhary Brahm Prakash Ayurved Charak Sansthan |
| Address |
PG Department of Kriyasharir, Chaudhary Brahm Prakash ayurved
Charak Sansthan, Khera Dabar South West DELHI 110073 India
South West
DELHI
110073
India
DELHI
110073
India |
| Phone |
9136226421 |
| Fax |
|
| Email |
rakesh3151@gmail.com |
|
|
Source of Monetary or Material Support
|
| Chaudhary Brahm Prakash ayurved Charak Sansthan,kheda dabur ,najafgarh,new delhi,pincode-767001 |
|
|
Primary Sponsor
|
| Name |
Chaudhary Brahm Prakash ayurved Charak Sansthan |
| Address |
Chaudhary Brahm Prakash ayurved
Charak Sansthan, Khera Dabar South West DELHI 110073 India
South West
DELHI |
| Type of Sponsor |
Government 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 shubham maharana |
Chaudhary Brahm Prakash ayurved Charak Sansthan |
PG Department of Kriyasharir, Chaudhary Brahm Prakash ayurved
Charak Sansthan, Khera Dabar South West DELHI 110073 India
South West
DELHI |
7008932094
smaharana243@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| IEC-CBPACS |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition:E118||Type 2 diabetes mellitus with unspecified complications. Ayurveda Condition: PRAMEHAH, |
|
|
Intervention / Comparator Agent
|
| sno | Intervention/Comparator | Type | Drug-Type | Procedure Name | Details |
|
|
|
Inclusion Criteria
|
| Age From |
30.00 Year(s) |
| Age To |
70.00 Year(s) |
| Gender |
Both |
| Details |
1 Individuals of both sexes with or without associated risk factors.
2 Individuals willing to participate in this study and has given his consent.
3 Individuals having no history of any apparent disease in last one month.
|
|
| ExclusionCriteria |
| Details |
No past history of cardiovascular events namely Coronary heart disease Stroke etc at the time of enrolment or no evidence of past cardiovascular event and other Individuals with known risk factors on evaluation shown evidence of cardiovascular complications |
|
|
Method of Generating Random Sequence
|
Not Applicable |
|
Method of Concealment
|
Not Applicable |
|
Blinding/Masking
|
Not Applicable |
|
Primary Outcome
|
| Outcome |
TimePoints |
| to rule out different risk factors of cardiovascular diseases with different ayurvedic prakritis among the patients of type 2 diabetes mellitus |
1 year |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| NIL |
NIL |
|
|
Target Sample Size
|
Total Sample Size="127"
Sample Size from India="127"
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)
|
01/06/2024 |
| 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
|
Diabetes is brought on by either insufficient insulin production by the pancreas or inefficient insulin use by the body. A hormone called insulin controls blood sugar levels. Uncontrolled diabetes frequently causes hyperglycemia, also known as high. blood glucose, which over time can seriously harm many different bodily systems, including the neurons and blood vessels. Atherosclerosis is the most common complication of diabetes. Epidemiologic and pathophysiologic evidence suggest a number of possible reasons for this. They include alterations in lipoproteins, platelets, soluble clotting factors, the balance of prostacyclin-thromboxane, blood pressure regulation, and arterial smooth muscle cell metabolism and proliferation. Dysfunction of the vascular endothelium is a hallmark of most conditions that are associated with both diabetes and atherosclerosis. Although the pathological link between diabetes and atherosclerosis is well-established, better comprehension of the underlying mechanisms is of utmost importance to identify novel potential molecular targets. For this a score predictor called ASCVD (atherosclerotic cardiovascular disease) risk score is a national guideline developed by the American College of Cardiology. It is a calculation of coming 10-year risk of having a cardiovascular problem, such as a heart attack or stroke. This risk estimate considers age, sex, race, cholesterol levels, blood pressure, medication use, diabetic status, and smoking status. Prakriti means nature, character and constitution of a person which
remains within our self from birth to till death. Prakriti never changes. This
constitution comprises of both “physical body†as well as “mental bodyâ€.Prakriti is the manifestation
of special characteristics due to predominance of Doshas (Vata, Pitta and Kapha
the functional component of body), & in these Prakriti indicates
predominance of specific Dosha in a human being. There are pre-natal and
post-natal factors which also determine the constitution of a body in minor way. Involvement of Dosha in Prakriti formation may be
individual or intermingled. So, Prakriti is of seven types, i.e. Vataj, Pittaj,
shaleshmaj, Vatajapittaaj, pittajashleshmaj, shleshmajavataj and one
Samadoshaj. Among these, Samadoshaj is considered as an excellent RESEARCH QUESTION Does risk of cardiovascular
disease (CVD) is associated with Prakriti among patients of type II diabetes mellitus to those who do not?
HYPOTHESIS
NULL HYPOTHESIS (Ho): Prakriti
is not associated with the risk factor of CVD among type II diabetes patients
ALTERNATE HYOPTHESIS (HA): Prakriti is associated with the risk factor of CVD among type
II diabetes patients AIM:To determine the risk of cardiovascular
diseases as per Prakriti among patients of Type II diabetes mellitus to those who do not by using
Atherosclerotic Cardiovascular Disease Score (ASCSVD). PRIMARY OBJECTIVE:Determine the
effect of Type II Diabetes Mellitus on cardiovascular disease as per Prakriti
by using atherosclerotic cardiovascular disease (ASCVD) score among patients of
diabetes mellitus to those who do not. SECONDARY
OBJECTIVE:To
find the association of other risk factors for developing cardiovascular
diseases by using ASCVD score. |