Ignite Creation Date:
2024-05-06 @ 3:47 PM
Last Modification Date:
2024-10-26 @ 1:57 PM
Study NCT ID:
NCT04759508
Status:
UNKNOWN
Last Update Posted:
2021-07-20
First Post:
2021-02-09
Brief Title:
Flaxseed in Controlling Blood Pressure of Patients
Sponsor:
BP Koirala Institute of Health Sciences
Organization:
BP Koirala Institute of Health Sciences
Study Overview
Official Title:
Effects of Flaxseed in Blood Pressure of Patients Taking Anti Hypertensive Drugs- A Double Blinded Placebo Controlled Randomized Trial
Status:
UNKNOWN
Status Verified Date:
2021-07
Last Known Status:
NOT_YET_RECRUITING
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
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 ielottery 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-alikePlacebo Capsule with no therapeutic effect respectively twice a day along with equivalent anti-hypertensive drugs in Medicine OPDBPKIHS 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 armssubjects will be followed up on 90th day The proforma which includes patients sociodemographic dataBP valueAdverse Drug reactions and drug interactions will be filled and data will be entered in MS-Excel subsequently and SPSS v115 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 CommitteeIRC 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
Detailed Description:
None
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None