Flaxseed in Controlling Blood Pressure of Patients

July 19, 2021 updated by: Rakesh Verma, B.P. Koirala Institute of Health Sciences

" Effects of Flaxseed in Blood Pressure of Patients Taking Anti Hypertensive Drugs- A Double Blinded Placebo Controlled Randomized Trial."

Hypertension is one of the major risk factor for global mortality. Approximately half of 17 million cardiovascular deaths worldwide are accounted for HTN. Multiple research for cost-effective medication for management of hypertension is going on. An effective alternative to medications in managing hypertension is through lifestyle modifications. Adopting healthy diet is a valuable strategy. Randomized controlled year-long trials observed impressive reductions in blood pressure in patients with hypertension consuming flaxseed daily. Therefore, attention has been garnered for flaxseed as a potentially valuable strategy for the management of hypertension. Double blinded, 2 parallel-group, prospective interventional randomized clinical trial. Investigators are planning to conduct most common and basic method of randomization i.e,"lottery method". This is most popular method and simplest method. In this method both Interventional and Placebo groups are numbered on separate slips of paper of same size, shape and color. They are folded and mixed up in a drum or a box or a container. A blindfold selection is made. Required numbers of slips are selected for the desired sample size. The selection of items thus depends on chance. The respective groups are then allocated in a sequence as Code A and Code B that will be concealed from the researcher (JR) enrolling and assessing participants in sequentially numbered, opaque, sealed and stapled envelope. After getting clearance from IRC, randomization will be done where Interventional and placebo groups will be given Flaxseed Capsule 500 mg and Look-alike(Placebo) Capsule with no therapeutic effect respectively twice a day along with equivalent anti-hypertensive drugs in Medicine OPD,BPKIHS. Blood pressure of all the enrolled subjects will be taken on first day of enrollment before start of intervention. After which subjects will be given respective capsules for first 30 days then follow-up. Assigned with respective arms,subjects will be followed up on 90th day. The proforma which includes patient's sociodemographic data,BP value,Adverse Drug reactions and drug interactions will be filled and data will be entered in MS-Excel subsequently and SPSS v11.5 will be used for further analysis. Investigators are planning to conduct a clinical trial in between 2 groups using power and sample size programme. Investigators need to enroll 36 subjects in each group, to be able to reject null hypothesis that means of two different groups are equal with probability of power 95% and at 5% level of significance. Hence sample size is taken 36 in each group. 10% increment will be done in each group if the subject will not come for follow up. Clinically diagnosed hypertension attending medicine OPD, BPKIHS, Dharan, satisfying the inclusion and exclusion criteria and willing to participate in the study will be enrolled. Prior to the conduction of the study ,ethical clearance will be obtained from the Institutional Review Committee(IRC) of BPKIHS and the clinical trial will be registered. Precaution will also be taken as far as possible to avoid pain and suffering and side effects of the medication to the subjects during the course of the study.

Study Overview

Status

Status

Indicates the current recruitment status or the expanded access status.
Not yet recruiting

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

Study Type

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Interventional

Enrollment (Anticipated)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
72

Phase

Phase

The stage of a clinical trial studying a drug or biological product, based on definitions developed by the U.S. Food and Drug Administration (FDA). The phase is based on the study's objective, the number of participants, and other characteristics. There are five phases: Early Phase 1 (formerly listed as Phase 0), Phase 1, Phase 2, Phase 3, and Phase 4. Not Applicable is used to describe trials without FDA-defined phases, including trials of devices or behavioral interventions.
  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact

The name and contact information for the person who can answer enrollment questions for a clinical study. Each location where the study is being conducted may also have a specific contact, who may be better able to answer those questions.

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

Inclusion Criteria:

  1. Age of the patient above 18 years.
  2. Patients who agree to take only physician advised medicine.
  3. Patient who strictly follow diet as advised.
  4. Patients taking single antihypertensive drug with equivalent doses.

Exclusion Criteria:

  1. Patient suffering from serious or recurrent infections.
  2. Pregnancy or breast feeding women, immunodeficiency or HIV patient.
  3. Patient with finding of any mental abnormality, which would interfere with or be affected by the study procedure .
  4. Patient with history of bleeding disorders.
  5. Hypersensitivity reaction or allergy to flaxseed.
  6. History of surgery within past 6 weeks
  7. Patient who do not will to give informed consent.
  8. Alcohol consumption > 30 U/day..
  9. Cigarette smoking > 2 pack/day
  10. Patients taking multiple antihypertensive drugs.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Double

Arms and Interventions

Participant Group / Arm

Participant Group / Arm

A group or subgroup of participants in a clinical trial that receives a specific intervention/treatment, or no intervention, according to the trial's protocol.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
Active Comparator: 500 mg BD Flax Oil Capsule with Antihypertensive drug
Flax Oil Capsule 500 mg twice a day will be administered alongside antihypertensive drug in newly diagnosed hypertensive subjects
Dietary supplement: Flax Oil Capsule
Flaxseed with brand name Flax Oil Capsule will be administered to subjects receiving antihypertensives.
Placebo Comparator: Placebo(Soya Oil) Capsule with Antihypertensive drug
No flax oil capsule,only placebo(soya oil) capsule will be administered alongside equivalent antihypertensive drug in newly diagnosed hypertensive subjects.
Dietary supplement: Placebo Soya Oil Capsule
Placebo capsule filled with soya oil and inert(inactive) substances will be administered to subjects remaining anti hypertensives.

What is the study measuring?

Primary Outcome Measures

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Measure Description
Time Frame
Flaxseed and Blood Pressure
Time Frame: 3 months
Assessing the effects of Flaxseeds in systolic and diastolic blood pressure of patients taking antihypertensive drugs
3 months

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
B.P. Koirala Institute of Health Sciences

Investigators

Investigators

A researcher involved in a clinical study. Related terms include site principal investigator, site sub-investigator, study chair, study director, and study principal investigator.
  • Principal Investigator: Rakesh Verma, MBBS, MD, B.P. Koirala Institute of Health Sciences

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Anticipated)

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
August 15, 2021

Primary Completion (Anticipated)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
September 15, 2021

Study Completion (Anticipated)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
October 15, 2021

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
February 9, 2021

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
February 17, 2021

First Posted (Actual)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
February 18, 2021

Study Record Updates

Last Update Posted (Actual)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
July 20, 2021

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
July 19, 2021

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
July 1, 2021

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant numbers.
  • IRC/1955/020

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

Yes

IPD Plan Description

Individuals enrolled in the respective arms will be shared

IPD Sharing Time Frame

Starting February 15,2021

IPD Sharing Access Criteria

Assess granted to sponsor, study team and data steward

IPD Sharing Supporting Information Type

  • Study Protocol
  • Statistical Analysis Plan (SAP)
  • Informed Consent Form (ICF)
  • Clinical Study Report (CSR)

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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