| CTRI Number |
CTRI/2025/02/079846 [Registered on: 03/02/2025] Trial Registered Prospectively |
| Last Modified On: |
28/01/2025 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Preventive
Other (Specify) [Individualized dietary education] |
| Study Design |
Randomized, Parallel Group, Active Controlled Trial |
|
Public Title of Study
|
Study of dietary pattern education to reduce homocysteine level and blood pressure |
|
Scientific Title of Study
|
Effectiveness of Customized Interventions on Therapeutic Response and Quality of Life among the Adults with H hypertension attending medicine OPDs of selected hospital in Sikkim A Randomized Controlled Trial |
| Trial Acronym |
Nil |
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Wangkheimayum Ashalata Devi |
| Designation |
Professor Sikkim Manipal College of Nursing |
| Affiliation |
Sikkim Manipal College of Nursing Sikkim Manipal University |
| Address |
5th Mile Tadong Gangtok Sikkim
East
SIKKIM
737102
India |
| Phone |
9734801181 |
| Fax |
|
| Email |
wangkheimayum.ad@smims.smu.edu.in |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Melita Sheilini |
| Designation |
Associate Professor |
| Affiliation |
Manipal College of Nursing Manipal Academy of Higher Education Manipal |
| Address |
Department of Medical Surgical Nursing
Manipal College of Nursing
Manipal Academy of Higher Education Manipal
Udupi
KARNATAKA
576104
India |
| Phone |
8095976561 |
| Fax |
|
| Email |
shyli.mel@manipal.edu |
|
Details of Contact Person
Public Query
|
| Name |
Dr Rinchen Doma Bhutia |
| Designation |
Assistant Professor |
| Affiliation |
Sikkim Manipal Institute of Medical Sciences Sikkim Manipal University |
| Address |
Department of Biochemistry
Sikkim Manipal Institute of Medical Sciences Sikkim Manipal University
5th Mile Tadong Gangtok Sikkim
East
SIKKIM
737102
India |
| Phone |
9434979961 |
| Fax |
|
| Email |
rinchen.b@smims.smu.edu.in |
|
|
Source of Monetary or Material Support
|
| Manipal College of Nursing Manipal Academy of Higher Education Madhavnagar Udupi District Manipal Karnataka 576104 |
|
|
Primary Sponsor
|
| Name |
Sikkim Manipal College of Nursing |
| Address |
Sikkim Manipal Institute of Medical Sciences, Sikkim Manipal University 5th Mile Tadong Gangtok Sikkim 737102 |
| Type of Sponsor |
Research institution |
|
|
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 Yogesh Ghimirey |
Sir Thutob Namgyal Memorial Hospital |
HOD Chief Consultant Department of Medicine STNM Hospital Gangtok Sikkim
737101
East
SIKKIM |
9547351026
gyogesh72@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| SMIMS 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 |
| Intervention |
Dietary interventions |
Intervention with routine care
includes
Individualized teaching on dietary pattern to reduce homocysteine and blood pressure level
Distribution of diet plan for male and female Indian adult as per recommendation kilocalories per day
Lifestyle modification and
Strict compliance to antihypertensive medication to reduce homocysteine and blood pressure so that to prevent from the risk of developing cardiovascular disease
|
| Comparator Agent |
Routine care
|
No intervention and only routine care
Reassessment at baseline two four and six months |
|
|
Inclusion Criteria
|
| Age From |
19.00 Year(s) |
| Age To |
60.00 Year(s) |
| Gender |
Both |
| Details |
Phase 1 550 sample size
Age 19-60 years
willing to participate in the study
Able to read and understand English Nepali language
Phase 2 104 sample size
Adults diagnosed to have H hypertension in phase 1
The participants will be randomized into experimental and control group 54 each in both group but it will be recalculated after the finding of the phase 1
|
|
| ExclusionCriteria |
| Details |
Phase 1
Hypertensive adults with comorbidities such as Coronary Artery Disease Myocardial Infarction Heart Failure Heart attack Stroke Diabetes Mellitus Chronic Kidney Disease Physical and or Mental disability
Adults who are under folic acid and vitamin B supplementation
adults with the report of serum homocysteine level more than 15micromole per liter
Phase 2
Adults with
Baseline systolic BP 180mmHg and diastolic BP 110mmHg
Report of serum homocysteine level more than 15micromole per liter |
|
|
Method of Generating Random Sequence
|
Stratified block randomization |
|
Method of Concealment
|
Sequentially numbered, sealed, opaque envelopes |
|
Blinding/Masking
|
Participant Blinded |
|
Primary Outcome
|
| Outcome |
TimePoints |
| Serum homocysteine level and Blood pressure |
During enrollment to the study
2nd month after intervention
4th month after intervention
6th month after intervention |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
Adherence to antihypertensives
Adherence to dietary practices and Quality of Life |
During enrollment to the study
2nd month after intervention
4th month after intervention
6th month after intervention |
|
|
Target Sample Size
|
Total Sample Size="550"
Sample Size from India="550"
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
|
Phase 2 |
|
Date of First Enrollment (India)
|
01/03/2025 |
| 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="4"
Months="6"
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 current study is a Randomized Controlled Trial among the adults with H-hypertension attending medicine OPDs of selected hospital in Sikkim. The objectives are to assess the proportion of H-hypertension in phase 1 & in phase 2, to find the effectiveness of customized interventions on therapeutic response among the subjects in experimental group as compared to the control group at baseline, two, four and six months. The primary outcome is to reduce the serum homocysteine level among participants with H-hypertension thereby reducing the blood pressure & the secondary outcome is the controlled blood pressure may contribute towards maintaining the QoL of the participant, the adherence to antihypertensives and dietary practices will be emphasized so that it will also contribute positively towards reduction of homocysteine and control of hypertension and prevent complications leading to CADs, MI, Heart attack, Heart failure, Stroke and CKD. |