Watch Laser Acupuncture With Nasal Radiation for Prevention of Coronary Artery Disease

Study Overview
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Brief Summary
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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
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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.

Official Title
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Laser Hemotherapy Trial for Coronary Artery Disease Prevention in High Risk Patients

Conditions
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Cardiovascular Risk Factor, Coronary Artery Disease

Intervention / Treatment
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* Device: low level laser hemotherapy


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: 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 Exclusion Criteria: 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

Ages Eligible for Study
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Minimum Age: 55 Years
Maximum Age: 65 Years

Sexes Eligible for Study
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Female

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: low level laser hemotherapy<br>Watch laser acupuncture and nasal irradiation | Device: low level laser hemotherapy<br>* semiconductor laser therapeutic instrument irradiate the circulating blood in the vessels of left hand acupoint and the mucosal tissue in the nasal cavity<br>* Other names: Watch laser;|
| No Intervention: control<br>all the participants in this group did not receive low level laser irradiation during the study period | |

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| changes of blood pressure | measuring blood pressure before and after each low level laser radiation | 8 weeks | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| changes in blood viscosity | measuring changes in blood viscosity before and after low level laser radiation session | 8 weeks | 
| change in IL-17 level | measuring changes in IL-17 level before and after low level laser radiation session | 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 | 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 | 45 days | 
| change in TC (total cholesterol) level | measuring changes in TC (total cholesterol) level before and after low level laser radiation session | 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 | 60 days | 
| change in TG (triglyceride) level | measuring changes in TG (triglyceride) level before and after low level laser radiation session | 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 | 60 days | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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hypertension, high blood viscosity, hypercholesterolemia