Effect of Khat Chewing on Blood Pressure and Heart Rate A... | NCT05213247

Studies
Effect of Khat Chewing on Blood Pressure and Heart Rate Among Healthy Adults

NCT05213247

Sponsor

Aljanad University for Science and Technology

Status

Completed

Last Update Posted

Jan 28, 2022Actual

Enrollment

100Actual

Phase

Not provided

Conditions

Blood Pressure
Heart Rate

Interventions

electronic apparatus (visocor OM50).

Countries

Yemen

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

Status Module

Record Verification Date

Jan 2022

Overall Recruitment Status or Expanded Access Status

Completed

Last Known Status

Not provided

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Apr 1, 2021Actual

Primary Completion Date

Dec 1, 2021Actual

Completion Date

Dec 1, 2021Actual

First Submitted Date

Dec 30, 2021

First Submission Date that Met QC Criteria

Jan 15, 2022

First Posted Date

Jan 28, 2022Actual

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Jan 15, 2022

Last Update Posted Date

Jan 28, 2022Actual

Sponsor/Collaborators Module

Responsible Party, by Official Title

Mujeeb Abdullah Saeed Sultan, Head of Pharmacy Department, Aljanad University for Science and TechnologyPrincipal Investigator

Lead Sponsor

Aljanad University for Science and TechnologyOTHER

Collaborators

Not provided

Oversight Module

Has Data Monitoring Committee (DMC)

Yes

Is FDA Regulated Drug

Is FDA Regulated Device

Yes

Is Unapproved Device

Not provided

Pediatric Postmarket Surveillance of a Device Product

Not provided

Product Exported from US

FDAAA801 Violation

Not provided

Description Module

Brief Summary

This study is a cross sectional study

Detailed Description

Objective: This study aims to investigate .ht short-term effect of khat on the diastolic and systolic blood pressure (DBP, SBP) and heart rate (HR) of yemeni adults. Factors associated with Khat chewing and Khat-dependence were also investigated. That the khat chewing is a growing public habit among yemeni people.

Design Module

Study Type

Observational

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Target Follow-Up Duration

Not provided

Phases

Not provided

Interventional Study Design

Allocation

Not provided

Intervention Model

Biospecimen

No data available

No data is available for this block.

Enrollment

100Actual

Arms/Interventions Module

Arm Groups

Not provided

Interventions

Name	Type	Description	Arm Group Labels	Other Names
electronic apparatus (visocor OM50).	Device	Measurement of blood pressure and heart rate

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
Blood Pressure	Elevation of blood pressure due to khat Chewing	April- December 2021

Secondary Outcomes

Not provided

Other Outcomes

Not provided

Eligibility Module

Eligibility Criteria

The participant should be free of any disease and should avoid eating or drinking anything that could affect on BP and HR within two khat before hours chewing (zero time)

Accepts Healthy Volunteers

Yes

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

15 Years

Maximum Age

65 Years

Standard Ages

ChildAdultOlder Adult

Study Population

This is a cross-sectional study conducted from April to September 2021 in Taiz, Yemen. 100 healthy adults were selected using a random sampling method.

Sampling Method

Probability Sample

Contacts/Locations Module

Central Contacts

Not provided

Overall Officials

Name	Affiliation	Role
Mujeeb Sultan	Aljanad University for Science and Technology	Principal Investigator

Locations

Facility	Status	City	State	ZIP	Country	Contacts
Mujeeb Sultan		Ta‘izz		04	Yemen

IPD Sharing Statement Module

Plan to Share IPD

Description

Not provided

Types

Not provided

Time Frame

Not provided

Access Criteria

Not provided

URL

Not provided