| CTRI Number |
CTRI/2020/05/025026 [Registered on: 05/05/2020] Trial Registered Prospectively |
| Last Modified On: |
23/04/2020 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Observational |
|
Type of Study
|
Cross Sectional Study |
| Study Design |
Other |
|
Public Title of Study
|
A Clinical trial to study the proportion of hypertension among Diabetes Mellitus |
|
Scientific Title of Study
|
A Cross sectional study on prevalence of hypertension among type 2 diabetic patients attending special OPD at AAGHIM Chennai |
| Trial Acronym |
|
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Dr Bharathi B |
| Designation |
PG Scholar |
| Affiliation |
Government Siddha Medical College Arumbakkam Chennai 600106 |
| Address |
Department of PG Gunapadam Government Siddha Medical College 6 Anna Arch road NSK Nagar Arumbakam Chennai 600106
Chennai
TAMIL NADU
600106
India |
| Phone |
7708274373 |
| Fax |
|
| Email |
bharujan93@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
PROF DR M D SARAVANA DEVI |
| Designation |
HOD and PROFESSOR |
| Affiliation |
Government Siddha Medical College Arumbakkam Chennai 600106 |
| Address |
Department of PG Gunapadam Government Siddha Medical College 6 Anna Arch road NSK Nagar Arumbakam Chennai 600106
Chennai
TAMIL NADU
600106
India |
| Phone |
9444693840 |
| Fax |
|
| Email |
saravanadhevi1965@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Dr Bharathi B |
| Designation |
PG Scholar |
| Affiliation |
Government Siddha Medical College Arumbakkam Chennai 600106 |
| Address |
Department of PG Gunapadam Government Siddha Medical College 6 Anna Arch road NSK Nagar Arumbakam Chennai 600106
Chennai
TAMIL NADU
600106
India |
| Phone |
7708274373 |
| Fax |
|
| Email |
bharujan93@gmail.com |
|
|
Source of Monetary or Material Support
|
| Government siddha medical college 6 Anna Arch Road NSK Nagar arumbakkam chennai 600106 Tamilnadu |
|
|
Primary Sponsor
|
| Name |
Government siddha medical college |
| Address |
Post graduate department of Gunapadam Government siddha medical college arumbakkam chennai 600106 Tamilnadu |
| 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 Bharathi B |
Arignar anna government hospital of indian medicine arumbakkam chennai |
Special OPD Siddha department Room no 3 Arignar anna government hospital of indian medicine arumbakkam chennai 600106
Chennai
TAMIL NADU |
7708274373
bharujan93@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Institutional ethical committee |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition: E116||Type 2 diabetes mellitus with other specified complications, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Intervention |
nil |
nil |
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
60.00 Year(s) |
| Gender |
Both |
| Details |
patients of both gender with age between 18 to 60 years attending special OPD at arignar anna government hospital of indian medicine |
|
| ExclusionCriteria |
| Details |
Age group less than 18 and above 60 years |
|
|
Method of Generating Random Sequence
|
Not Applicable |
|
Method of Concealment
|
Not Applicable |
|
Blinding/Masking
|
Not Applicable |
|
Primary Outcome
|
| Outcome |
TimePoints |
The current study will identify the prevalence of Hypertension among Type 2 Diabetic patients attending Out Patient Department at Arignar Anna Government Hospital of Indian Medicine and the add on therapies among the patients being treated with siddha medicine, which may emphasis to screen for undiagnosed Hypertension and other better patient care.
|
90 days |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
I hope that the results obtained will help the practitioners to gain knowledge about the prevalence of Hypertension among Type 2 Diabetic patients whom they treat and educate the patients and titre drug dosage accordingly.
|
90 days |
|
|
Target Sample Size
|
Total Sample Size="200"
Sample Size from India="200"
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)
|
05/05/2020 |
| 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="0"
Months="3"
Days="0" |
|
Recruitment Status of Trial (Global)
|
Not Applicable |
| Recruitment Status of Trial (India) |
Not Yet Recruiting |
|
Publication Details
|
NIL |
|
Individual Participant Data (IPD) Sharing Statement
|
Will individual participant data (IPD) be shared publicly (including data dictionaries)?
|
|
Brief Summary
|
It is a cross sectional study to estimate the prevalence of Hypertension among Type 2 Diabetic patients attending Out Patient Department at Arignar Anna Government Hospital of Indian Medicine which and the add on therapies among the patients being treated with siddha medicine, which may emphasis to screen for undiagnosed Hypertension and other better patient care.The questionnaire which consists of 25 questions to assess the knowledge about the prevalence of Hypertension among Type 2 Diabetic patients whom they treat and educate them and titre drug dosage accordingly. |