Back to resultsWatch Laser Acupuncture With Nasal Radiation for Prevention of Coronary Artery Disease
Primary Purpose
Cardiovascular Risk Factor, Coronary Artery Disease
Status
Completed
Phase
Not Applicable
Locations
Egypt
Study Type
Interventional
Intervention
low level laser hemotherapy
Sponsored by
About this trial
This is an interventional treatment trial for Cardiovascular Risk Factor focused on measuring hypertension, high blood viscosity, hypercholesterolemia
Eligibility Criteria
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
Sites / Locations
- Cairo
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
No Intervention
Arm Label
low level laser hemotherapy
control
Arm Description
Watch laser acupuncture and nasal irradiation
all the participants in this group did not receive low level laser irradiation during the study period
Outcomes
Primary Outcome Measures
changes of blood pressure
measuring blood pressure before and after each low level laser radiation
Secondary Outcome Measures
changes in blood viscosity
measuring changes in blood viscosity before and after low level laser radiation session
change in IL-17 level
measuring changes in IL-17 level before and after low level laser radiation session
change in functional capacity
measuring of 6 minute walking test before and after low level laser irradiation as an indicator of functional capacity improving
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
change in TC (total cholesterol) level
measuring changes in TC (total cholesterol) level before and after low level laser radiation session
change in LDL (low density lipoprotien) level
measuring changes in LDL (low density lipoprotien) level before and after low level laser radiation session
change in TG (triglyceride) level
measuring changes in TG (triglyceride) level before and after low level laser radiation session
change in HDL (high density lipoprotien) level
measuring changes in HDL (high density lipoprotien) level before and after low level laser radiation session
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT03454594
Brief Title
Watch Laser Acupuncture With Nasal Radiation for Prevention of Coronary Artery Disease
Official Title
Laser Hemotherapy Trial for Coronary Artery Disease Prevention in High Risk Patients
Study Type
Interventional
2. Study Status
Record Verification Date
February 2019
Overall Recruitment Status
Completed
Study Start Date
May 1, 2018 (Actual)
Primary Completion Date
August 5, 2018 (Actual)
Study Completion Date
December 30, 2018 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Cairo University
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
Yes
5. Study Description
Brief 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)
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Cardiovascular Risk Factor, Coronary Artery Disease
Keywords
hypertension, high blood viscosity, hypercholesterolemia
7. Study Design
Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
50 (Actual)
8. Arms, Groups, and Interventions
Arm Title
low level laser hemotherapy
Arm Type
Experimental
Arm Description
Watch laser acupuncture and nasal irradiation
Arm Title
control
Arm Type
No Intervention
Arm Description
all the participants in this group did not receive low level laser irradiation during the study period
Intervention Type
Device
Intervention Name(s)
low level laser hemotherapy
Other Intervention Name(s)
Watch laser
Intervention Description
semiconductor laser therapeutic instrument irradiate the circulating blood in the vessels of left hand acupoint and the mucosal tissue in the nasal cavity
Primary Outcome Measure Information:
Title
changes of blood pressure
Description
measuring blood pressure before and after each low level laser radiation
Time Frame
8 weeks
Secondary Outcome Measure Information:
Title
changes in blood viscosity
Description
measuring changes in blood viscosity before and after low level laser radiation session
Time Frame
8 weeks
Title
change in IL-17 level
Description
measuring changes in IL-17 level before and after low level laser radiation session
Time Frame
45 days
Title
change in functional capacity
Description
measuring of 6 minute walking test before and after low level laser irradiation as an indicator of functional capacity improving
Time Frame
70 days
Title
change in CD 8 (cluster of differentiation 8) level
Description
measuring changes in CD 8 (cluster of differentiation 8) level before and after low level laser radiation session
Time Frame
45 days
Title
change in TC (total cholesterol) level
Description
measuring changes in TC (total cholesterol) level before and after low level laser radiation session
Time Frame
60 days
Title
change in LDL (low density lipoprotien) level
Description
measuring changes in LDL (low density lipoprotien) level before and after low level laser radiation session
Time Frame
60 days
Title
change in TG (triglyceride) level
Description
measuring changes in TG (triglyceride) level before and after low level laser radiation session
Time Frame
60 days
Title
change in HDL (high density lipoprotien) level
Description
measuring changes in HDL (high density lipoprotien) level before and after low level laser radiation session
Time Frame
60 days
10. Eligibility
Sex
Female
Minimum Age & Unit of Time
55 Years
Maximum Age & Unit of Time
65 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Cairo Giza, MD
Organizational Affiliation
Cairo University
Official's Role
Principal Investigator
Facility Information:
Facility Name
Cairo
City
Giza
State/Province
Dokki
ZIP/Postal Code
11432
Country
Egypt
12. IPD Sharing Statement
Plan to Share IPD
Yes
IPD Sharing Plan Description
De-identified participated data for underlie results reported in this trial
IPD Sharing Time Frame
data will be available after 6 months of study completion and ending 36 months
IPD Sharing Access Criteria
proposals should directed to Dr.EbtesamNagy@cu.edu.eg. To gain access, data requestors will need to sign a data access agreement
Learn more about this trial
Watch Laser Acupuncture With Nasal Radiation for Prevention of Coronary Artery Disease
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