Cardiovascular Protective Role of Laser Acupuncture in Systemic Lupus

January 14, 2022 updated by: Ali Mohamed Ali ismail, Cairo University
Systemic lupus erythematosus is a chronic and multisystemic autoimmune disorder which predominantly affecting women. The most common cause of death in lupus patients affected by disease for more than 5 years is cardiovascular disease due to presence of some factors as oxidative stress, pro-inflammatory cytokines , dyslipidemia, diabetes, and hypertension.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Detailed Description

laser acupuncture (active or sham) for one month (3 days/week ) on acupoint number 14 of GV meridian, acupoint number 4 and 11 of large intestine, acupoint number 34 of gall bladder meridian, acupoint number 3 of liver meridian, acupoint number 4, 12, and 9 of conception vessel meridian, acupoint number 40, 36, and 25 of stomach meridian, acupoint number 6 of spleen meridian, and acupoint number 5 of triple energizer meridian (laser will be applied for 1 min on every acupiont) in lupus females

Study Type

Interventional

Enrollment (Actual)

60

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Egypt
    • Dokki
      • Giza, Dokki, Egypt
        • Faculty of Physical Therapy Cairo University

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 47 years (ADULT)

Accepts Healthy Volunteers

No

Genders Eligible for Study

Female

Description

Inclusion Criteria:

  • lupus females
  • 60 patients

Exclusion Criteria:

  • pregnancy
  • cardiovascular diseases
  • respiratory diseases

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: PREVENTION
  • Allocation: RANDOMIZED
  • Interventional Model: PARALLEL
  • Masking: DOUBLE

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
ACTIVE_COMPARATOR: group 1
thirty lupus women received laser acupuncture (active) for one month (3 days week) on acupoint number 14 of GV meridian, acupoint number 4 and 11 of large intestine, acupoint number 34 of gall bladder meridian, acupoint number 3 of liver meridian, acupoint number 4, 12, and 9 of conception vessel meridian, acupoint number 40, 36, and 25 of stomach meridian, acupoint number 6 of spleen meridian, and acupoint number 5 of triple energizer meridian (laser was applied for 1 min on every acupiont).
Device: laser application on acupoints
laser acupuncture
SHAM_COMPARATOR: group 2
thirty lupus women received laser acupuncture (sham) for one month (3 days) on acupoint number 14 of GV meridian, acupoint number 4 and 11 of large intestine, acupoint number 34 of gall bladder meridian, acupoint number 3 of liver meridian, acupoint number 4, 12, and 9 of conception vessel meridian, acupoint number 40, 36, and 25 of stomach meridian, acupoint number 6 of spleen meridian, and acupoint number 5 of triple energizer meridian (laser was be applied for 1 min on every acupiont).
Device: laser application on acupoints
laser acupuncture

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Malondialdehyde
Time Frame: It was measured after 4 weeks
anti-oxidative stress factor
It was measured after 4 weeks

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
systole
Time Frame: It was measured after 4 weeks
blood pressure
It was measured after 4 weeks
diastole
Time Frame: It was measured after 4 weeks
blood pressure
It was measured after 4 weeks
blood glucose
Time Frame: It was be measured after 4 weeks
fasting
It was be measured after 4 weeks
erythrocyte sedimentation rate (1 hour)
Time Frame: It was measured after 4 weeks
inflammatory marker
It was measured after 4 weeks
erythrocyte sedimentation rate (2 hour)
Time Frame: It was measured after 4 weeks
inflammatory marker
It was measured after 4 weeks
c reactive protein
Time Frame: It was measured after 4 weeks
inflammatory marker
It was measured after 4 weeks
adenosine triphosphate
Time Frame: It was measured after 4 weeks
energy production marker
It was measured after 4 weeks
Nitrate
Time Frame: It was measured after 4 weeks
oxidative stress factor
It was measured after 4 weeks
Glutathione
Time Frame: It was measured after 4 weeks
antioxidant marker
It was measured after 4 weeks

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Cairo University

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (ACTUAL)

July 12, 2021

Primary Completion (ACTUAL)

November 10, 2021

Study Completion (ACTUAL)

November 30, 2021

Study Registration Dates

First Submitted

July 11, 2021

First Submitted That Met QC Criteria

July 11, 2021

First Posted (ACTUAL)

July 21, 2021

Study Record Updates

Last Update Posted (ACTUAL)

January 28, 2022

Last Update Submitted That Met QC Criteria

January 14, 2022

Last Verified

January 1, 2022

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • P.T.REC/012/003252

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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