Back to resultsLaser Acupuncture in Egyptian Systemic Lupus Females With Insulin Resistance
Primary Purpose
Systemic Lupus Erythematosus, PreDiabetes
Status
Recruiting
Phase
Not Applicable
Locations
Egypt
Study Type
Interventional
Intervention
active laser
sham laser
Sponsored by
About this trial
This is an interventional treatment trial for Systemic Lupus Erythematosus
Eligibility Criteria
Inclusion Criteria: prediabetic lupus females (n =64) Exclusion Criteria: obesity diabetes heart or respiratory problems
Sites / Locations
- Cairo UnoversityRecruiting
Arms of the Study
Arm 1
Arm 2
Arm Type
Active Comparator
Sham Comparator
Arm Label
laser (active laser)
laser (sham laser)
Arm Description
32 lupus prediabetic women will receive laser acupuncture (active laser) 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)
32 lupus prediabetic women will receive laser acupuncture (sham . i.e power of the device will be zero) 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)
Outcomes
Primary Outcome Measures
Malondialdehyde
oxidative stress indicator
Secondary Outcome Measures
systolic blood pressure
manual sphygmomanometer
diastolic blood pressure
manual sphygmomanometer
blood glucose
it will be measured in fasting status
erythrocyte sedimentation rate (at first hour)
it will be measured in serum
erythrocyte sedimentation rate (at second hour)
it will be measured in serum
C reactive protein
it will be measured in serum
adenosine triphosphate
it a measure for energy production
Nitrate
it will be measured in serum
Glutathione
it will be measured in serum
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT05632029
Brief Title
Laser Acupuncture in Egyptian Systemic Lupus Females With Insulin Resistance
Official Title
Laser Acupuncture in Systemic Lupus Women With Prediabetes
Study Type
Interventional
2. Study Status
Record Verification Date
November 2022
Overall Recruitment Status
Recruiting
Study Start Date
October 20, 2022 (Actual)
Primary Completion Date
March 30, 2023 (Anticipated)
Study Completion Date
March 30, 2023 (Anticipated)
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
glucose hemosatasis, oxidative stress, abnormalities of blood pressures, and high inflammatory status is high presented in lupus patients.
Detailed Description
64 lupus prediabetic women will equally distributed to group A (n =32 that will receive 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 will be applied for 1 min on every acupiont) or group B (n =32 this group will receive the same protocol of group A but the points will be sham points)
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Systemic Lupus Erythematosus, PreDiabetes
7. Study Design
Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
Outcomes Assessor
Allocation
Randomized
Enrollment
64 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
laser (active laser)
Arm Type
Active Comparator
Arm Description
32 lupus prediabetic women will receive laser acupuncture (active laser) 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)
Arm Title
laser (sham laser)
Arm Type
Sham Comparator
Arm Description
32 lupus prediabetic women will receive laser acupuncture (sham . i.e power of the device will be zero) 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)
Intervention Type
Device
Intervention Name(s)
active laser
Intervention Description
32 lupus prediabetic women will receive laser acupuncture (active laser) 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)
Intervention Type
Device
Intervention Name(s)
sham laser
Intervention Description
32 lupus prediabetic women will receive laser acupuncture (sham laser, i.e power of device will be zero watt) 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)
Primary Outcome Measure Information:
Title
Malondialdehyde
Description
oxidative stress indicator
Time Frame
It will be measured after 4 weeks of laser application
Secondary Outcome Measure Information:
Title
systolic blood pressure
Description
manual sphygmomanometer
Time Frame
It will be measured after 4 weeks of laser application
Title
diastolic blood pressure
Description
manual sphygmomanometer
Time Frame
It will be measured after 4 weeks of laser application
Title
blood glucose
Description
it will be measured in fasting status
Time Frame
It will be measured after 4 weeks of laser application
Title
erythrocyte sedimentation rate (at first hour)
Description
it will be measured in serum
Time Frame
It will be measured after 4 weeks of laser application
Title
erythrocyte sedimentation rate (at second hour)
Description
it will be measured in serum
Time Frame
It will be measured after 4 weeks of laser application
Title
C reactive protein
Description
it will be measured in serum
Time Frame
It will be measured after 4 weeks of laser application
Title
adenosine triphosphate
Description
it a measure for energy production
Time Frame
It will be measured after 4 weeks of laser application
Title
Nitrate
Description
it will be measured in serum
Time Frame
It will be measured after 4 weeks of laser application
Title
Glutathione
Description
it will be measured in serum
Time Frame
It will be measured after 4 weeks of laser application
10. Eligibility
Sex
Female
Gender Based
Yes
Gender Eligibility Description
based on self-representation of gender identity.
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
50 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
prediabetic lupus females (n =64)
Exclusion Criteria:
obesity diabetes heart or respiratory problems
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Ali Ismail, lecturer
Phone
02 01005154209
Email
ali.mohamed@pt.cu.edu.eg
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
Cairo Unoversity
City
Giza
Country
Egypt
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Ali Ismail, lecturer
Phone
01005154209
Email
allooka2012@gmail.com
12. IPD Sharing Statement
Learn more about this trial
Laser Acupuncture in Egyptian Systemic Lupus Females With Insulin Resistance
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