NCT03454594

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)

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
50

participants targeted

Target at P25-P50 for not_applicable

Timeline
Completed

Started May 2018

Shorter than P25 for not_applicable

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

February 25, 2018

Completed
9 days until next milestone

First Posted

Study publicly available on registry

March 6, 2018

Completed
2 months until next milestone

Study Start

First participant enrolled

May 1, 2018

Completed
3 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

August 5, 2018

Completed
5 months until next milestone

Study Completion

Last participant's last visit for all outcomes

December 30, 2018

Completed
Last Updated

February 7, 2019

Status Verified

February 1, 2019

Enrollment Period

3 months

First QC Date

February 25, 2018

Last Update Submit

February 5, 2019

Conditions

Keywords

hypertensionhigh blood viscosityhypercholesterolemia

Outcome Measures

Primary Outcomes (1)

  • changes of blood pressure

    measuring blood pressure before and after each low level laser radiation

    8 weeks

Secondary Outcomes (8)

  • changes in blood viscosity

    8 weeks

  • change in IL-17 level

    45 days

  • change in functional capacity

    70 days

  • change in CD 8 (cluster of differentiation 8) level

    45 days

  • change in TC (total cholesterol) level

    60 days

  • +3 more secondary outcomes

Study Arms (2)

low level laser hemotherapy

EXPERIMENTAL

Watch laser acupuncture and nasal irradiation

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

Interventions

semiconductor laser therapeutic instrument irradiate the circulating blood in the vessels of left hand acupoint and the mucosal tissue in the nasal cavity

Also known as: Watch laser
low level laser hemotherapy

Eligibility Criteria

Age55 Years - 65 Years
Sexfemale
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Cairo

Giza, Dokki, 11432, Egypt

Location

MeSH Terms

Conditions

Coronary Artery DiseaseHypertensionHypercholesterolemia

Condition Hierarchy (Ancestors)

Coronary DiseaseMyocardial IschemiaHeart DiseasesCardiovascular DiseasesArteriosclerosisArterial Occlusive DiseasesVascular DiseasesHyperlipidemiasDyslipidemiasLipid Metabolism DisordersMetabolic DiseasesNutritional and Metabolic Diseases

Study Officials

  • Cairo Giza, MD

    Cairo University

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
lecturer assistance at Cairo University

Study Record Dates

First Submitted

February 25, 2018

First Posted

March 6, 2018

Study Start

May 1, 2018

Primary Completion

August 5, 2018

Study Completion

December 30, 2018

Last Updated

February 7, 2019

Record last verified: 2019-02

Data Sharing

IPD Sharing
Will share

De-identified participated data for underlie results reported in this trial

Shared Documents
STUDY PROTOCOL
Time Frame
data will be available after 6 months of study completion and ending 36 months
Access Criteria
proposals should directed to Dr.EbtesamNagy@cu.edu.eg. To gain access, data requestors will need to sign a data access agreement

Locations