Flaxseed in Controlling Blood Pressure of Patients

NCT04759508 | Unknown DMC

• 1 other identifier: IRC/1955/020
• Study Type: interventional
• Target: 72
• Locations: 0 countries
• Sites: N/A

Brief Summary

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.

Conditions

Hypertension

Outcome Measures

Primary Outcomes (1)

• Flaxseed and Blood Pressure

  Assessing the effects of Flaxseeds in systolic and diastolic blood pressure of patients taking antihypertensive drugs

  3 months

Study Arms (2)

500 mg BD Flax Oil Capsule with Antihypertensive drug

ACTIVE COMPARATOR

Flax Oil Capsule 500 mg twice a day will be administered alongside antihypertensive drug in newly diagnosed hypertensive subjects

Dietary Supplement: Flax Oil Capsule

Placebo(Soya Oil) Capsule with Antihypertensive drug

PLACEBO COMPARATOR

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

Interventions

Flax Oil Capsule DIETARY_SUPPLEMENT

Flaxseed with brand name Flax Oil Capsule will be administered to subjects receiving antihypertensives.

500 mg BD Flax Oil Capsule with Antihypertensive drug

Placebo Soya Oil Capsule DIETARY_SUPPLEMENT

Placebo capsule filled with soya oil and inert(inactive) substances will be administered to subjects remaining anti hypertensives.

Placebo(Soya Oil) Capsule with Antihypertensive drug

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

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

You may not qualify if:

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

Sponsors & Collaborators

• B.P. Koirala Institute of Health Sciences: lead

Related Publications (1)

• 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.

  PMID: 24126178 BACKGROUND

MeSH Terms

Conditions

Hypertension

Interventions

Linseed Oil

Condition Hierarchy (Ancestors)

Vascular Diseases; Cardiovascular Diseases

Intervention Hierarchy (Ancestors)

Fats, Unsaturated; Fats; Lipids; Plant Oils; Oils; Plant Preparations; Biological Products; Complex Mixtures

Study Officials

• Rakesh Verma, MBBS, MD

  B.P. Koirala Institute of Health Sciences

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Rakesh Verma, MBBS, MD

CONTACT

9812560610; tipparv@gmail.com

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, INVESTIGATOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal Investigator

Study Record Dates

• First Submitted: February 9, 2021
• First Posted: February 18, 2021
• Study Start: August 15, 2021
• Primary Completion: September 15, 2021
• Study Completion: October 15, 2021
• Last Updated: July 20, 2021

Record last verified: 2021-07

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL, SAP, ICF, CSR
• Time Frame: Starting February 15,2021
• Access Criteria: Assess granted to sponsor, study team and data steward