| CTRI Number |
CTRI/2012/09/002967 [Registered on: 06/09/2012] Trial Registered Retrospectively |
| Last Modified On: |
11/11/2018 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Other (Specify) [Dietary approaches to stop hypertension] |
| Study Design |
Single Arm Study |
|
Public Title of Study
|
Role of diet in controlling Hypertension |
|
Scientific Title of Study
|
A short-term pilot study investigating the efficacy of DASH diet in reducing systolic and/or diastolic blood pressure in patient with essential hypertension |
| Trial Acronym |
|
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| 256/1/MBHMCH/CH/ADM/11/12 |
Protocol Number |
| U1111-1130-9341 |
UTN |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Munmun Koley |
| Designation |
House-staff |
| Affiliation |
Mahesh Bhattacharyya Homoeopathic Medical College and Hospital |
| Address |
Village- Champsara, P.O- Baidyabati, Hooghly
Drainage Canal road, Doomurjala, 711104
Haora
WEST BENGAL
712222
India |
| Phone |
919830816022 |
| Fax |
|
| Email |
dr.mkoley@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Malay Mundle |
| Designation |
Associate Professor |
| Affiliation |
Mahesh Bhattacharyya Homoeopathic Medical College and Hospital |
| Address |
7 Suresh Sarkar Road
Kolkata
Drainage Canal road Doomurjala
711104
Haora
WEST BENGAL
700014
India |
| Phone |
919903334810 |
| Fax |
|
| Email |
mmundle53cm@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Munmun Koley |
| Designation |
House-staff |
| Affiliation |
Mahesh Bhattacharyya Homoeopathic Medical College and Hospital |
| Address |
Village Champsara
Post Office Baidyabati
Hooghly
Drainage Canal road Doomurjala
711104
Haora
WEST BENGAL
712222
India |
| Phone |
919830816022 |
| Fax |
|
| Email |
dr.mkoley@gmail.com |
|
|
Source of Monetary or Material Support
|
| Mahesh Bhattacharyya Homoeopathic Medical College and Hospital |
|
|
Primary Sponsor
|
| Name |
Mahesh Bhattacharyya Homoeopathic Medical College and Hospital |
| Address |
Drainage canal road, Doomurjala, Howrah, 711104 |
| 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 |
| Munmun Koley |
Medicine OPD |
Mahesh Bhattacharyya Homoeopathic Medical College and Hospital. Drainage Canalroad, Doomurjala,711104
Haora
WEST BENGAL |
919830816022
dr.mkoley@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Institutional Ethical Commitee of Mahesh Bhattacharyya Homoeopathic Medical College and Hospital |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
Health Condition / Problems Studied
Modification(s)
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition: I10||Essential (primary) hypertension, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Intervention |
DASH diet(Dietary approaches to stop hypertension) |
High amount of fruits and vegetable intake, inclusion of fish and low fat milk, reduction of sodium and fat intake.Grains 7-8 servings, vegetable 4-5 servings, fruits 4-5 servings, low fat milk 2-3 servings, lean meat 2 or less servings,Sodium 2300mg.Intake of DASH diet for 2 months and after that results are analysed. |
| Comparator Agent |
not applicable |
Single arm study,hence no comparator is being used. |
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
65.00 Year(s) |
| Gender |
Both |
| Details |
Age between 18-65 years.
Both sexes.
History of suffering of essential hypertension for at least 6 months.
History, examination and routein investigations showing no evidence of secondary cause. |
|
| ExclusionCriteria |
| Details |
Diagnose case of secondary hypertension.
Any kind of continued anti-hypertensive therapy for at least 6 months.
Malignant hypertension, isolated systolic hypertension, labile hypertension.
Presence of severe concomitant disease(s).
Failure of organ(s).
Pregnancy, breast feeding and likelihood of pregnency. |
|
|
Method of Generating Random Sequence
|
Not Applicable |
|
Method of Concealment
|
Not Applicable |
|
Blinding/Masking
|
Not Applicable |
|
Primary Outcome
|
| Outcome |
TimePoints |
| Reduction in systolic and/or diastolic blood pressure. |
2 months |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| Improvement in symptom score. |
2 months. |
|
|
Target Sample Size
|
Total Sample Size="30"
Sample Size from India="30"
Final Enrollment numbers achieved (Total)= ""
Final Enrollment numbers achieved (India)="" |
|
Phase of Trial
|
N/A |
|
Date of First Enrollment (India)
|
03/04/2012 |
| Date of Study Completion (India) |
Date Missing |
| Date of First Enrollment (Global) |
Date Missing |
| Date of Study Completion (Global) |
Date Missing |
|
Estimated Duration of Trial
|
Years="0"
Months="2"
Days="0" |
Recruitment Status of Trial (Global)
Modification(s)
|
Not Applicable |
| Recruitment Status of Trial (India) |
Completed |
|
Publication Details
|
|
|
Individual Participant Data (IPD) Sharing Statement
|
Will individual participant data (IPD) be shared publicly (including data dictionaries)?
|
|
Brief Summary
|
Hypertension is the commonest cardiovascular disorder posing major public health challenge to the world population by causing coronary artery disease (24%), stroke(57%), left ventricular failure etc. As dietary intervension has a major control over every disease process, the aim of our study is exploring the clinically favourable impact of dietary approaches over blood pressure in hypertensive patients.Objectives of our study is to see the effect of DASH diet over blood pressure and symptom score. It is a single arm, experimental, prospective, interventional, short-arm, non-randomised, before and after comparison study without control over 30 hypertensive patients. Outcomes are analysed by the help of paired t-test after 2 months of dietary intervention (DASH diet), which consist of inclusion of fish and low fat milk in food, intake of high amount of fruits and vegetable in food and reduction of sodium and fat intake. |