Cardiovascular Risk FactorNCT03454594
Watch Laser Acupuncture With Nasal Radiation for Prevention of Coronary Artery Disease
A study testing low level laser hemotherapy in people with Cardiovascular Risk Factor and Coronary Artery Disease, run by Cairo University at 1 site in Egypt.
Trial summary
This study will evaluate the effect of low level laser blood radiation applied to all participants for prevention of coronary artery disease in patients with high risk (hypertension,high blood viscosity, hypercholesterolemia as well as related immune issues) Read more about this study
- Who is it for?
- Ages 55 to 65 years, women only
- Conditions the study is for
- Cardiovascular Risk Factor, Coronary Artery Disease
- What is being tested?
- low level laser hemotherapy
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 50 participants
- Where
- 1 siteEgypt
- Study dates
- 1 May 2018to 30 Dec 2018
- Phase
- Interventional
- 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 55 to 65 years
- Women only
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- stage I hypertensive patients
- patients from 30 to 34.9 kg/m2 body mass index
- medically stable patients
- all participants have sufficient cognition enough to understand the requirements of the study
Who cannot join
- history of malignant disease
- smoking
- history of progressive fatal disease
- history of drug or alcohol abuse
- blood donation within at least 30 days
- pregnant, trying to be pregnant or breast feeding
- cognitive impairment that will make it difficult to partake in the study
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Laser Hemotherapy Trial for Coronary Artery Disease Prevention in High Risk Patients
This study will evaluate the effect of low level laser blood radiation applied to all participants for prevention of coronary artery disease in patients with high risk (hypertension,high blood viscosity, hypercholesterolemia as well as related immune issues)
Read the detailed description
The areas of low - intensity laser use have expanded in several conditions by different mechanisms and ways. Hypertension as one of coronary artery disease risk factors and early indicator of future cardiovascular events with high blood viscosity and elevated blood cholesterol levels with immune-pathological basis became necessary issue to be handled. Low Level Laser irradiation effects on blood is very essential way in revealing the mechanisms of the action of laser radiation on biological tissues by means of changes in metabolism, leading to molecular, cellular and systemic changes.
- Being tested
- low level laser hemotherapy
- Keywords
- hypertension, high blood viscosity, hypercholesterolemia
- Medical subject headings
- Coronary Artery Disease, Hypertension, Hypercholesterolemia
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
low level laser hemotherapyDevice
Also called Watch laser
semiconductor laser therapeutic instrument irradiate the circulating blood in the vessels of left hand acupoint and the mucosal tissue in the nasal cavity
| Study group | Role | What they receive |
|---|---|---|
| low level laser hemotherapy | Experimental | Watch laser acupuncture and nasal irradiation Receives: Device: low level laser hemotherapy |
| control | No intervention | all the participants in this group did not receive low level laser irradiation during the study period |
What is being measured
The primary outcome is the main question the study is designed to answer.
changes of blood pressure
measuring blood pressure before and after each low level laser radiation
Measured: 8 weeks
Secondary outcomes (8)
changes in blood viscosity
measuring changes in blood viscosity before and after low level laser radiation session
Measured: 8 weeks
change in IL-17 level
measuring changes in IL-17 level before and after low level laser radiation session
Measured: 45 days
change in functional capacity
measuring of 6 minute walking test before and after low level laser irradiation as an indicator of functional capacity improving
Measured: 70 days
change in CD 8 (cluster of differentiation 8) level
measuring changes in CD 8 (cluster of differentiation 8) level before and after low level laser radiation session
Measured: 45 days
change in TC (total cholesterol) level
measuring changes in TC (total cholesterol) level before and after low level laser radiation session
Measured: 60 days
change in LDL (low density lipoprotien) level
measuring changes in LDL (low density lipoprotien) level before and after low level laser radiation session
Measured: 60 days
change in TG (triglyceride) level
measuring changes in TG (triglyceride) level before and after low level laser radiation session
Measured: 60 days
change in HDL (high density lipoprotien) level
measuring changes in HDL (high density lipoprotien) level before and after low level laser radiation session
Measured: 60 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted6 Mar 2018
- Study start1 May 2018
- Primary completion5 Aug 2018
- Study completion30 Dec 2018
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Cardiovascular Risk FactorStudies of the same condition, open and under way.
- More trials run by Cairo UniversityThe sponsor's other registered studies.
- 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
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 50 participants (actual)
Sponsor and investigators
- Lead sponsor
- Cairo University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Ebtesam Nabil, Cairo University
- Investigators
- Cairo Giza, MD, Principal investigator, Cairo University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03454594
- Sponsor's protocol ID
- P.T.REC/012/001561
- Status last verified
- Feb 2019
- First submitted
- 25 Feb 2018
- Last updated
- 7 Feb 2019
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: De-identified participated data for underlie results reported in this trial
Study at a glance
From the registry record, last updated by the sponsor on 7 Feb 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Laser Hemotherapy Trial for Coronary Artery Disease Prevention in High Risk Patients
- ClinicalTrials.gov ID
- NCT03454594
- Acronym / sponsor ID
- P.T.REC/012/001561
- Keywords
- hypertension, high blood viscosity, hypercholesterolemia
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 50 participants (actual)
- Lead sponsor
- Cairo UniversityUniversity, hospital or other
- Study start
- 1 May 2018 (actual)
- Primary completion
- 5 Aug 2018 (actual)
- Study completion
- 30 Dec 2018 (actual)
- First posted
- 6 Mar 2018 (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 will evaluate the effect of low level laser blood radiation applied to all participants for prevention of coronary artery disease in patients with high risk (hypertension,high blood viscosity, hypercholesterolemia as well as related immune issues)
Detailed description
The areas of low - intensity laser use have expanded in several conditions by different mechanisms and ways. Hypertension as one of coronary artery disease risk factors and early indicator of future cardiovascular events with high blood viscosity and elevated blood cholesterol levels with immune-pathological basis became necessary issue to be handled. Low Level Laser irradiation effects on blood is very essential way in revealing the mechanisms of the action of laser radiation on biological tissues by means of changes in metabolism, leading to molecular, cellular and systemic changes.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| low level laser hemotherapy | Experimental | Device: low level laser hemotherapyWatch laser acupuncture and nasal irradiation |
| control | No intervention | –all the participants in this group did not receive low level laser irradiation during the study period |
Who may qualify
- Ages
- 55 to 65 years
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- stage I hypertensive patients
- patients from 30 to 34.9 kg/m2 body mass index
- medically stable patients
- all participants have sufficient cognition enough to understand the requirements of the study
Key exclusion criteria (7 listed)
- history of malignant disease
- smoking
- history of progressive fatal disease
- history of drug or alcohol abuse
- blood donation within at least 30 days
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 |
|---|---|---|
| low level laser hemotherapyAlso: Watch lasersemiconductor laser therapeutic instrument irradiate the circulating blood in the vessels of left hand acupoint and the mucosal tissue in the nasal cavity | Device | low level laser hemotherapy |
Primary outcome
changes of blood pressure
Time frame: 8 weeks
measuring blood pressure before and after each low level laser radiation
8 secondary outcomes
changes in blood viscosity
Time frame: 8 weeks
change in IL-17 level
Time frame: 45 days
change in functional capacity
Time frame: 70 days
change in CD 8 (cluster of differentiation 8) level
Time frame: 45 days
change in TC (total cholesterol) level
Time frame: 60 days
change in LDL (low density lipoprotien) level
Time frame: 60 days
change in TG (triglyceride) level
Time frame: 60 days
change in HDL (high density lipoprotien) level
Time frame: 60 days
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 7 Feb 2019.
- Individual participant dataSharing planned: Yes. De-identified participated data for underlie results reported in this trial
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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.
Cairo Giza, MD principal investigator
Cairo University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing low level laser hemotherapy in people with Cardiovascular Risk Factor and Coronary Artery Disease, run by Cairo University at 1 site in Egypt.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 7 exclusion criteria. 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 7 Feb 2019. 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 Egypt. 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?
changes of blood pressure (time frame: 8 weeks). 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 7 Feb 2019.