search
Back to results

Cardiovascular Protective Role of Laser Acupuncture in Systemic Lupus

Primary Purpose

System; Lupus Erythematosus

Status
Completed
Phase
Not Applicable
Locations
Egypt
Study Type
Interventional
Intervention
laser application on acupoints
Sponsored by
Cairo University
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional prevention trial for System; Lupus Erythematosus

Eligibility Criteria

18 Years - 47 Years (Adult)FemaleDoes not accept healthy volunteers

Inclusion Criteria:

  • lupus females
  • 60 patients

Exclusion Criteria:

  • pregnancy
  • cardiovascular diseases
  • respiratory diseases

Sites / Locations

  • Faculty of Physical Therapy Cairo University

Arms of the Study

Arm 1

Arm 2

Arm Type

Active Comparator

Sham Comparator

Arm Label

group 1

group 2

Arm Description

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).

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).

Outcomes

Primary Outcome Measures

Malondialdehyde
anti-oxidative stress factor

Secondary Outcome Measures

systole
blood pressure
diastole
blood pressure
blood glucose
fasting
erythrocyte sedimentation rate (1 hour)
inflammatory marker
erythrocyte sedimentation rate (2 hour)
inflammatory marker
c reactive protein
inflammatory marker
adenosine triphosphate
energy production marker
Nitrate
oxidative stress factor
Glutathione
antioxidant marker

Full Information

First Posted
July 11, 2021
Last Updated
January 14, 2022
Sponsor
Cairo University
search

1. Study Identification

Unique Protocol Identification Number
NCT04970199
Brief Title
Cardiovascular Protective Role of Laser Acupuncture in Systemic Lupus
Official Title
Cardiovascular Protective Role of Laser Acupuncture in Systemic Lupus
Study Type
Interventional

2. Study Status

Record Verification Date
January 2022
Overall Recruitment Status
Completed
Study Start Date
July 12, 2021 (Actual)
Primary Completion Date
November 10, 2021 (Actual)
Study Completion Date
November 30, 2021 (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

5. Study Description

Brief Summary
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.
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

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
System; Lupus Erythematosus

7. Study Design

Primary Purpose
Prevention
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
ParticipantOutcomes Assessor
Allocation
Randomized
Enrollment
60 (Actual)

8. Arms, Groups, and Interventions

Arm Title
group 1
Arm Type
Active Comparator
Arm Description
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).
Arm Title
group 2
Arm Type
Sham Comparator
Arm Description
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).
Intervention Type
Device
Intervention Name(s)
laser application on acupoints
Intervention Description
laser acupuncture
Primary Outcome Measure Information:
Title
Malondialdehyde
Description
anti-oxidative stress factor
Time Frame
It was measured after 4 weeks
Secondary Outcome Measure Information:
Title
systole
Description
blood pressure
Time Frame
It was measured after 4 weeks
Title
diastole
Description
blood pressure
Time Frame
It was measured after 4 weeks
Title
blood glucose
Description
fasting
Time Frame
It was be measured after 4 weeks
Title
erythrocyte sedimentation rate (1 hour)
Description
inflammatory marker
Time Frame
It was measured after 4 weeks
Title
erythrocyte sedimentation rate (2 hour)
Description
inflammatory marker
Time Frame
It was measured after 4 weeks
Title
c reactive protein
Description
inflammatory marker
Time Frame
It was measured after 4 weeks
Title
adenosine triphosphate
Description
energy production marker
Time Frame
It was measured after 4 weeks
Title
Nitrate
Description
oxidative stress factor
Time Frame
It was measured after 4 weeks
Title
Glutathione
Description
antioxidant marker
Time Frame
It was measured after 4 weeks

10. Eligibility

Sex
Female
Gender Based
Yes
Gender Eligibility Description
self-representation of gender identity.
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
47 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: lupus females 60 patients Exclusion Criteria: pregnancy cardiovascular diseases respiratory diseases
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Ali Ismail, lecturer
Organizational Affiliation
Cairo University
Official's Role
Principal Investigator
Facility Information:
Facility Name
Faculty of Physical Therapy Cairo University
City
Giza
State/Province
Dokki
Country
Egypt

12. IPD Sharing Statement

Learn more about this trial

Cardiovascular Protective Role of Laser Acupuncture in Systemic Lupus

We'll reach out to this number within 24 hrs