| CTRI Number |
CTRI/2025/02/081225 [Registered on: 24/02/2025] Trial Registered Prospectively |
| Last Modified On: |
21/02/2025 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Observational |
|
Type of Study
|
ANALYTICAL CROSS SECTIONAL |
| Study Design |
Other |
|
Public Title of Study
|
A Study to assess the ayurvedic biological factors such as Dosha Dhatu, Srotas ,Agni , Prakriti in patient having Isolated Hypertryglyceridaemia |
|
Scientific Title of Study
|
An Analytical cross-sectional study to assess the Ayurvedic Biological factors in Isolated Hypertriglyceridemia |
| 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 Gopakumar S |
| Designation |
Registrar |
| Affiliation |
|
| Address |
Kerala University of Health Sciences Thrissur
Thrissur
KERALA
680596
India |
| Phone |
9447361304 |
| Fax |
|
| Email |
drgopakumar73@yahoo.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Gopakumar S |
| Designation |
Registrar |
| Affiliation |
|
| Address |
Kerala University of Health Sciences Thrissur
Thrissur
KERALA
680596
India |
| Phone |
9447361304 |
| Fax |
|
| Email |
drgopakumar73@yahoo.com |
|
Details of Contact Person
Public Query
|
| Name |
Dr Gopakumar S |
| Designation |
Registrar |
| Affiliation |
|
| Address |
kerala University of Health Sciences Thrissur
Thrissur
KERALA
680596
India |
| Phone |
9447361304 |
| Fax |
|
| Email |
drgopakumar73@yahoo.com |
|
|
Source of Monetary or Material Support
|
| Government Ayurveda College Pariyaram Kannur Kerala India 670503 |
|
|
Primary Sponsor
|
| Name |
GOVERNMENT AYURVEDA COLLEGE PARIYARAM KANNUR |
| Address |
Government Ayurveda Medical College Pariyaram kannur 670503 Kerala India |
| 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 Anzalna T R |
GOVERNMENT AYURVEDA COLLEGE PARIYARAM KANNUR |
Department of Roganidana Government Ayurveda College Pariyaram Kannur 670503
Kannur
KERALA |
9497813723
anzalnaumaiban@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| INTITUTIONAL ETHICS COMMITTE GOVERNMENT AYURVEDA COLLEGE PARIYARAM KANNUR |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition:E781||Pure hyperglyceridemia. Ayurveda Condition: MEDOVAHASROTOVIKARAH, |
|
|
Intervention / Comparator Agent
|
| sno | Intervention/Comparator | Type | Drug-Type | Procedure Name | Details |
|
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
70.00 Year(s) |
| Gender |
Both |
| Details |
Individuals having normal serum total cholesterol and high triglycerides are taken as case group and individuals having normal serum total cholesterol and serum triglyceride are taken as comparison group |
|
| ExclusionCriteria |
| Details |
individuals with serious systemic and mental illness and also individuals taking immunosuppressants , thiazides , beta blockers , corticosteroids, atypical antipsychotics |
|
|
Method of Generating Random Sequence
|
Not Applicable |
|
Method of Concealment
|
Not Applicable |
|
Blinding/Masking
|
Not Applicable |
|
Primary Outcome
|
| Outcome |
TimePoints |
| To assess the involvement of different ayurveda biological factors like dosha dathu srotas agni in isolated Hypertriglyceridaemia |
25 weeks |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| By Assessing these factors treatments to modify these factors isgiven to improve the condition |
25 weeks |
|
|
Target Sample Size
|
Total Sample Size="69"
Sample Size from India="69"
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)
|
05/03/2025 |
| 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 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
|
The study mainly focus to understand what happens in individuals who have isolated triglyceride increase compared to other lipids . what is the ayurvedic biological factor responsible for this condition . finding this factor helps to identify what to be corrected as triglycerides are a major concern in the development of heart diseases . |