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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT03454594
Other study ID # P.T.REC/012/001561
Secondary ID
Status Completed
Phase N/A
First received
Last updated
Start date May 1, 2018
Est. completion date December 30, 2018

Study information

Verified date February 2019
Source Cairo University
Contact n/a
Is FDA regulated No
Health authority
Study type Interventional

Clinical 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)


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.


Recruitment information / eligibility

Status Completed
Enrollment 50
Est. completion date December 30, 2018
Est. primary completion date August 5, 2018
Accepts healthy volunteers No
Gender Female
Age group 55 Years to 65 Years
Eligibility 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

Study Design


Intervention

Device:
low level laser hemotherapy
semiconductor laser therapeutic instrument irradiate the circulating blood in the vessels of left hand acupoint and the mucosal tissue in the nasal cavity

Locations

Country Name City State
Egypt Cairo Giza Dokki

Sponsors (1)

Lead Sponsor Collaborator
Cairo University

Country where clinical trial is conducted

Egypt, 

Outcome

Type Measure Description Time frame Safety issue
Primary changes of blood pressure measuring blood pressure before and after each low level laser radiation 8 weeks
Secondary changes in blood viscosity measuring changes in blood viscosity before and after low level laser radiation session 8 weeks
Secondary change in IL-17 level measuring changes in IL-17 level before and after low level laser radiation session 45 days
Secondary 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
Secondary 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
Secondary change in TC (total cholesterol) level measuring changes in TC (total cholesterol) level before and after low level laser radiation session 60 days
Secondary 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
Secondary change in TG (triglyceride) level measuring changes in TG (triglyceride) level before and after low level laser radiation session 60 days
Secondary 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
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