Flaxseed in Controlling Blood Pressure of Patients

" 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: Not yet recruiting
• Conditions: Hypertension
• Intervention / Treatment: Dietary supplement: Flax Oil Capsule; Dietary supplement: Placebo Soya Oil Capsule

• Study Type: Interventional
• Enrollment (Anticipated): 72
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Rakesh Verma, MBBS, MD; Phone Number: 9812560610; Email: tipparv@gmail.com

Participation Criteria

Eligibility Criteria

• 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

How is the study designed?

Design Details

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

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
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

Outcome Measure	Measure Description	Time Frame
Flaxseed and Blood Pressure	Assessing the effects of Flaxseeds in systolic and diastolic blood pressure of patients taking antihypertensive drugs	3 months

Collaborators and Investigators

• Sponsor: B.P. Koirala Institute of Health Sciences
• Investigators: Principal Investigator: Rakesh Verma, MBBS, MD, B.P. Koirala Institute of Health Sciences

Publications and helpful links

General Publications

• Rodriguez-Leyva D, Weighell W, Edel AL, LaVallee R, Dibrov E, Pinneker R, Maddaford TG, Ramjiawan B, Aliani M, Guzman R, Pierce GN. Potent antihypertensive action of dietary flaxseed in hypertensive patients. Hypertension. 2013 Dec;62(6):1081-9. doi: 10.1161/HYPERTENSIONAHA.113.02094. Epub 2013 Oct 14.

Study record dates

Study Major Dates

• Study Start (Anticipated): August 15, 2021
• Primary Completion (Anticipated): September 15, 2021
• Study Completion (Anticipated): October 15, 2021

Study Registration Dates

• First Submitted: February 9, 2021
• First Submitted That Met QC Criteria: February 17, 2021
• First Posted (Actual): February 18, 2021

Study Record Updates

• Last Update Posted (Actual): July 20, 2021
• Last Update Submitted That Met QC Criteria: July 19, 2021
• Last Verified: July 1, 2021

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Cardiovascular Diseases; Vascular Diseases; Hypertension
• Other Study ID 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