| CTRI Number |
CTRI/2025/07/091563 [Registered on: 24/07/2025] Trial Registered Prospectively |
| Last Modified On: |
23/07/2025 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Observational |
|
Type of Study
|
Case Control Study |
| Study Design |
Other |
|
Public Title of Study
|
Genetics in high blood pressure patients |
|
Scientific Title of Study
|
Genetic Study of Circadian Locomotor Output Cycle Kaput (CLOCK) Gene Polymorphism in Essential Hypertension |
| 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. Vineeth Muraleedharan Nair |
| Designation |
Junior Resident cum Post Graduate Department of Medicine |
| Affiliation |
BLDE Deemed to be University Shri B M Patil Medical College, Hospital and Research Centre |
| Address |
Room No 309, Department of Medicine, BLDE (Deemed to be University) Shri B M Patil Medical College Hospital and Research Centre, Vijayapura, Karnataka
586103, India.
Bijapur
KARNATAKA
586103
India |
| Phone |
9595295892 |
| Fax |
|
| Email |
vineethnair8@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr. Badiger Sharanabasawappa |
| Designation |
Professor Department of Medicine |
| Affiliation |
BLDE Deemed to be University Shri B M Patil Medical College, Hospital and Research Centre |
| Address |
Room No 309, Department of Medicine, BLDE (Deemed to be University) Shri B M Patil Medical College Hospital and Research Centre, Vijayapura, Karnataka
586103, India.
Bijapur
KARNATAKA
586103
India |
| Phone |
9448434927 |
| Fax |
|
| Email |
sharanrb@rediffmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Dr. Badiger Sharanabasawappa |
| Designation |
Professor Department of Medicine |
| Affiliation |
BLDE Deemed to be University Shri B M Patil Medical College, Hospital and Research Centre |
| Address |
Room No 309, Department of Medicine, BLDE (Deemed to be University) Shri B M Patil Medical College Hospital and Research Centre, Vijayapura, Karnataka
586103, India.
Bijapur
KARNATAKA
586103
India |
| Phone |
9448434927 |
| Fax |
|
| Email |
sharanrb@rediffmail.com |
|
|
Source of Monetary or Material Support
|
| BLDE (Deemed to be University) Shri B M Patil Medical College Hospital and Research Centre, Vijayapura, Karnataka
586103, India. |
|
|
Primary Sponsor
|
| Name |
BLDE Deemed to be University Shri B M Patil Medical College Hospital and Research Centre |
| Address |
BLDE Deemed to be University Shri B M Patil Medical College Hospital and Research Centre, Vijayapura, Karnataka
586103, India. |
| Type of Sponsor |
Private medical college |
|
|
Details of Secondary Sponsor
|
| Name |
Address |
| Dr VINEETH MURALEEDHARAN NAIR |
ROOM NO 309 DEPARTMENT OF MEDICINE BLDE (DEEMED TO BE UNIVERSITY) SHRI B M PATIL MEDICAL COLLEGE HOSPITAL AND RESEARCH CENTRE Bijapur KARNATAKA
586103 India
|
|
|
Countries of Recruitment
|
India |
|
Sites of Study
|
| No of Sites = 1 |
| Name of Principal
Investigator |
Name of Site |
Site Address |
Phone/Fax/Email |
| Dr Vineeth Muraleedharan Nair |
BLDE Deemed to be University Shri B M Patil Medical College, Hospital and Research Centre |
Room No 309, Department of Medicine BLDE (Deemed to be University) Shri B M Patil Medical College Hospital and Research Centre, Vijayapura. Karnataka
586103, India.
Bijapur
KARNATAKA |
9595295892
vineethnair8@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| IEC |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Healthy Human Volunteers |
HEALTHY HUMAN VOLUNTEERS WITHOUT ESSENTIAL (PRIMARY) HYPERTENSION |
| Patients |
(1) ICD-10 Condition: I10||Essential (primary) hypertension, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Intervention |
Nil |
Nil |
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
80.00 Year(s) |
| Gender |
Both |
| Details |
Patients Admitted or Attending OPD With Essential Hypertension |
|
| ExclusionCriteria |
| Details |
1. Patients with Secondary Hypertension.
2. Patients with Renal Disorders.
3. Patients with Thyroid Disorders.
|
|
|
Method of Generating Random Sequence
|
Not Applicable |
|
Method of Concealment
|
Not Applicable |
|
Blinding/Masking
|
Not Applicable |
|
Primary Outcome
|
| Outcome |
TimePoints |
| To Identify the Individual Risk of CLOCK Gene Mutation in Patients with Essential Hypertension |
12 months |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| This study will be helpful to development of biomarkers to the clinician and the community. By using the study’s aggregated data for early detection of essential hypertension and early intervention, the burden of disease in terms of morbidity and mortality of disease will be reduced. |
12 MONTHS |
|
|
Target Sample Size
|
Total Sample Size="180"
Sample Size from India="180"
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)
|
04/08/2025 |
| 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
|
THIS STUDY IS A CASE CONTROL STUDY OF CIRCADIAN LOCOMOTOR OUTPUT CYCLE KAPUT (CLOCK) GENE POLYMORPHISM IN HOSPITAL PATIENTS WITH ESSENTIAL HYPERTENSION, IT WILL BE CONDUCTED IN BLDE (DEEMED TO BE UNIVERSITY) SHRI B.M PATIL MEDICAL COLLEGE HOSPITAL AND RESEARCH CENTRE VIJAYAPURA. TOTAL OF 180 PEOPLE (90 PATIENTS AND 90 HEALTHY CONTROLS) WILL BE TAKEN INTO THIS STUDY AFTER APPLYING THE INCLUSION AND EXCLUSION CRITERIA. THE PRIMARY OUTCOME OF THE STUDY IS TO DETECT RISK OF CLOCK GENE POLYMORPHISM IN PATIENTS WITH ESSENTIAL HYPERTENSION. THE SECONDARY OUTCOME OF THE STUDY WILL BE HELPFUL TO DEVELOPMENT OF BIOMARKERS TO THE CLINICIAN AND THE COMMUNITY. BY USING THE STUDY’S AGGREGATED DATA FOR THE EARLY DETECTION OF THOSE AT RISK FOR ESSENTIAL HYPERTENSION AND EARLY INTERVENTION,THE BURDEN OF DISEASE IN TERMS OF MORBIDITY AND MORTALITY OF DISEASE WILL BE REDUCED. |