| CTRI Number |
CTRI/2020/03/023868 [Registered on: 09/03/2020] Trial Registered Prospectively |
| Last Modified On: |
28/02/2020 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Observational |
|
Type of Study
|
Case Control Study |
| Study Design |
Single Arm Study |
|
Public Title of Study
|
URIC ACID A BIOCHEMICAL MARKER FOR HYPERTENSION WILL BE STUDIED IN PATIENTS HAVING HIGH BP RECORDINGS IN THE HOSPITAL TO ESTABLISH A RELATIONSHIP BETWEEN URIC ACID AND HIGH BP. |
|
Scientific Title of Study
|
Study of serum uric acid in essential hypertension:In a tertiary care hospital |
| Trial Acronym |
|
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Dr Parth Vhora |
| Designation |
Junior resident |
| Affiliation |
KMC Manipal |
| Address |
Department Of General Medicine KMC Manipal
Udupi
KARNATAKA
576104
India |
| Phone |
7498380923 |
| Fax |
|
| Email |
parthvhora@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
DR BA SHASTRY |
| Designation |
PROFFESSOR AND UNIT HEAD,KMC MANIPAL |
| Affiliation |
KMC Manipal |
| Address |
Department Of General Medicine KMC Manipal
Udupi
KARNATAKA
576104
India |
| Phone |
9845702450 |
| Fax |
|
| Email |
ba.shastry@manipal.edu |
|
Details of Contact Person
Public Query
|
| Name |
Dr Parth Vhora |
| Designation |
Junior resident |
| Affiliation |
KMC Manipal |
| Address |
Department Of General Medicine KMC Manipal
Udupi
KARNATAKA
576104
India |
| Phone |
7498380923 |
| Fax |
|
| Email |
parthvhora@gmail.com |
|
|
Source of Monetary or Material Support
|
| Kasturba Hospital,Madhav nagar,manipal,karnataka-576104 |
|
|
Primary Sponsor
|
| Name |
DR Parth Vhora |
| Address |
Department Of General Medicine
KMC Manipal |
| 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 |
| Dr Parth Vhora |
Kasturba Hospital,Manipal |
Department Of General Medicne
KMC Manipal
576104
Udupi
KARNATAKA |
7498380923
parthvhora@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Kasturba medical college and Kasturba hospital Institutional Ethics Committee |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition: I10||Essential (primary) hypertension, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Comparator Agent |
NIL |
NIL |
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
90.00 Year(s) |
| Gender |
Both |
| Details |
Only essential hypertensives will be taken for the study
Controls will be age and sex matched to the cases. |
|
| ExclusionCriteria |
| Details |
Secondary causes of hypertension
Gout
All Leukaemias
Polycythemia
Chronic obstructive pulmonary disease
Tuberculosis
Chronic kidney disease
Type 2 diabetes mellitus
Drugs Causing Hyperuricaemia –Thiazide diuretic,Loop diuretics
|
|
|
Method of Generating Random Sequence
|
Not Applicable |
|
Method of Concealment
|
Not Applicable |
|
Blinding/Masking
|
Not Applicable |
|
Primary Outcome
|
| Outcome |
TimePoints |
Serum uric acid has a positive correlation with essential hypertension.
Higher grade of hypertension is associated with higher serum uric acid levels. |
serum uric acid levels will be assesed at the end of 1 YEAR in essential hypertensives and compared with controls. |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| Serum uric acid of essentail hypertensives will be compared with that of age and sex matched controls. |
At 1 month intervals till 1 year. |
|
|
Target Sample Size
|
Total Sample Size="108"
Sample Size from India="108"
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)
|
10/03/2020 |
| 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="1"
Months="0"
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
|
Serum uric acid serves as a prognostic marker in the pathogenesis of hypertension. It serves as a prognostic marker in the complications of essential hypertension like diabetes and cardiovascular diseases.By measuring serum uric acid in essential hypertensives and comparing it with normotensive subjects,a association between essential hypertension and serum uric acid can be established.Essential hypertension has many modifiable risk factors but there is a need to identify additonal risk factors like serum uiric acid to prevent complications and pathogenesis of essential hypertension. My study hopes to find this association between essential hypertension and serum uric acid levels. |