| CTRI Number |
CTRI/2023/03/051115 [Registered on: 28/03/2023] Trial Registered Prospectively |
| Last Modified On: |
27/03/2023 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Observational |
|
Type of Study
|
Case Control Study |
| Study Design |
Other |
|
Public Title of Study
|
To assess the association between Metabolic alterations based on Ayurveda principles with Cardiac Dysfunction in Diabetic population |
|
Scientific Title of Study
|
Association between Metabolic alterations based on Ayurveda principles with Cardiac Dysfunction in Diabetic population - A Case Control Study |
| Trial Acronym |
|
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
MINI VG |
| Designation |
PhD Scholar (Part-time) |
| Affiliation |
Vaidyaratnam Ayurveda College, ollur, Thrissur |
| Address |
Department of Kayachikitsa,
Vaidyaratnam Ayurveda College, ollur, Thrissur
Thrissur
KERALA
680306
India |
| Phone |
9446380592 |
| Fax |
|
| Email |
mini.tinku@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr GIRI PV |
| Designation |
Professor and HOD |
| Affiliation |
Vaidyaratnam Ayurveda College, ollur, Thrissur |
| Address |
Professor and HOD,
Department of Kayachikitsa,
Vaidyaratnam Ayurveda College, ollur, Thrissur
Thrissur
KERALA
680306
India |
| Phone |
9447527366 |
| Fax |
|
| Email |
doctorviswagiri@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
MINI VG |
| Designation |
PhD Scholar (Part-time) |
| Affiliation |
Vaidyaratnam Ayurveda College, ollur, Thrissur |
| Address |
Department of Kayachikitsa,
Vaidyaratnam Ayurveda College, ollur, Thrissur
Thrissur
KERALA
680306
India |
| Phone |
9446380592 |
| Fax |
|
| Email |
mini.tinku@gmail.com |
|
|
Source of Monetary or Material Support
|
| Vaidyaratnam Ayurveda College, Ollur, Thrissur |
|
|
Primary Sponsor
|
| Name |
MINI V G |
| Address |
Department of Kayachikitsa,
Vaidyaratnam Ayurveda College,
Ollur, Thrissur. |
| 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 |
| MINI VG |
Vaidyaratnam Ayurveda College Hospital |
Department of Kayachikitsa, Vaidyaratnam Ayurveda College, Thaikkattussery P.O,
Ollur, Thrissur
Thrissur
KERALA |
9446380592
mini.tinku@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Vaidyaratnam Ayurveda College, Ollur, Thrissur |
Approved |
|
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Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition: I501||Left ventricular failure, unspecified, |
|
|
Intervention / Comparator Agent
|
| sno | Intervention/Comparator | Type | Drug-Type | Procedure Name | Details |
|
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
65.00 Year(s) |
| Gender |
Both |
| Details |
CASES: Type 2 Diabetes mellitus patients associated with cardiac dysfunctions diagnosed as per the current American Diabetes Association and American Heart Association guidelines.
CONTROL: All eligibility criteria defined for cases with exception of cardiac dysfunction in Type 2 Diabetes mellitus population. |
|
| ExclusionCriteria |
| Details |
Pregnant women, Lactating mother, those who are unwilling to give informed consent and diabetic patients with other symptomatic co-morbidities. |
|
|
Method of Generating Random Sequence
|
Not Applicable |
|
Method of Concealment
|
Not Applicable |
|
Blinding/Masking
|
Not Applicable |
|
Primary Outcome
|
| Outcome |
TimePoints |
| By assessing the association between the metabolic alterations based on Ayurveda Principles in Diabetic patients with Cardiac dysfunction for early detection, prevention and to develop Ayurvedic management strategies. |
single point |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| Development of Clinical markers based on Ayurveda Principles for the early detection, prevention and management of cardiac dysfunction in Cardiac Population |
single point |
|
|
Target Sample Size
|
Total Sample Size="162"
Sample Size from India="162"
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)
|
04/04/2023 |
| 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="7"
Days="0" |
|
Recruitment Status of Trial (Global)
|
Not Yet Recruiting |
| Recruitment Status of Trial (India) |
Not Yet Recruiting |
|
Publication Details
|
not yet |
|
Individual Participant Data (IPD) Sharing Statement
|
Will individual participant data (IPD) be shared publicly (including data dictionaries)?
Response - NO
|
|
Brief Summary
|
The most deleterious consequence of developing T2DM are cardiac dysfunction due to coronary artery disease and myocardial dysfunction. Despite advances in therapy, cardiac dysfunction associated with Diabetes still carries an ominous prognosis and a significant socioeconomic burden. In Ayurveda, diagnosis and management of diseases are generally based on personalized screening. So, this observational case control study design is intended to study the association between metabolic alterations in the terms of Ayurveda terminologies such as concepts of Ama, vitiation of agni, Srothas and Ojas. Thus could help in early, detection, screening and primary prevention of Cardiac Dysfunction in diabetic population. |