Blood PressureNCT05213247
Effect of Khat Chewing on Blood Pressure and Heart Rate Among Healthy Adults
An observational study of Blood Pressure and Heart Rate, run by Aljanad University for Science and Technology at 1 site in Yemen.
Trial summary
This study is a cross sectional study Read more about this study
- Who is it for?
- Ages 15 to 65 yearsHealthy volunteers can take part
- Conditions the study is for
- Blood Pressure, Heart Rate
- What is being tested?
- electronic apparatus (visocor OM50).
- Type of treatment
- Medical device
- How many people
- 100 participants
- Where
- 1 siteYemen
- Study dates
- 1 Apr 2021to 1 Dec 2021
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 15 to 65 years
- All sexes
- Healthy volunteers accepted
- Child, Adult, Older 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.
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)
Trial locations and contacts
1 site in 1 country.
About this study
Official title: A Short-Term Follow-Up Study on the Effect of Khat Chewing on Blood Pressure and Heart Rate Among Healthy Adults in Taiz, Yemen: Its Associated Factors and SDS-Khat
This study is a cross sectional study
Read the 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.
- Conditions
- Blood Pressure, Heart Rate
- Being tested
- electronic apparatus (visocor OM50).
- Keywords
- Khat-SDS, Blood Pressure, Heart Rate
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
electronic apparatus (visocor OM50).Device
Measurement of blood pressure and heart rate
What is being measured
The primary outcome is the main question the study is designed to answer.
Blood Pressure
Elevation of blood pressure due to khat Chewing
Measured: April- December 2021
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted28 Jan 2022
- Study start1 Apr 2021
- Primary completion1 Dec 2021
- Study completion1 Dec 2021
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Blood PressureStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Case only
- Time perspective
- Cross-sectional
- Enrolment
- 100 participants (actual)
Sponsor and investigators
- Lead sponsor
- Aljanad University for Science and Technology
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Mujeeb Abdullah Saeed Sultan, Aljanad University for Science and Technology
- Investigators
- Mujeeb Sultan, Principal investigator, Aljanad University for Science and Technology
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05213247
- Sponsor's protocol ID
- JustMed01/2021
- Status last verified
- Jan 2022
- First submitted
- 30 Dec 2021
- Last updated
- 28 Jan 2022
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- Yes
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 28 Jan 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Short-Term Follow-Up Study on the Effect of Khat Chewing on Blood Pressure and Heart Rate Among Healthy Adults in Taiz, Yemen: Its Associated Factors and SDS-Khat
- ClinicalTrials.gov ID
- NCT05213247
- Acronym / sponsor ID
- JustMed01/2021
- Conditions
- Blood Pressure, Heart Rate
- Keywords
- Khat-SDS, Blood Pressure, Heart Rate
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 100 participants (actual)
- Lead sponsor
- Aljanad University for Science and TechnologyUniversity, hospital or other
- Study start
- 1 Apr 2021 (actual)
- Primary completion
- 1 Dec 2021 (actual)
- Study completion
- 1 Dec 2021 (actual)
- First posted
- 28 Jan 2022 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Observational model
- Case only
- Time perspective
- Cross-sectional
Who may qualify
- Ages
- 15 to 65 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child, Adult, Older 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| electronic apparatus (visocor OM50).Measurement of blood pressure and heart rate | Device | – |
Primary outcome
Blood Pressure
Time frame: April- December 2021
Elevation of blood pressure due to khat Chewing
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 28 Jan 2022.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Mujeeb Sultan principal investigator
Aljanad University for Science and Technology
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Blood Pressure and Heart Rate, run by Aljanad University for Science and Technology at 1 site in Yemen.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 28 Jan 2022. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Yemen. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Blood Pressure (time frame: April- December 2021). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 28 Jan 2022.