Laser Acupuncture in Egyptian Systemic Lupus Females With Insulin Resistance

Laser Acupuncture in Systemic Lupus Women With Prediabetes

glucose hemosatasis, oxidative stress, abnormalities of blood pressures, and high inflammatory status is high presented in lupus patients.

Study Overview

• Status: Recruiting
• Conditions: Systemic Lupus Erythematosus; PreDiabetes
• Intervention / Treatment: Device: active laser; Device: sham laser

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)

• Study Type: Interventional
• Enrollment (Anticipated): 64
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: ali ismail, lecturer; Phone Number: 02 01005154209; Email: ali.mohamed@pt.cu.edu.eg

Study Locations

• Egypt
  • Giza, Egypt
    • Recruiting
    • Cairo Unoversity

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 50 years (Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: Female

Description

Inclusion Criteria:

• prediabetic lupus females (n =64)

Exclusion Criteria:

• obesity diabetes heart or respiratory problems

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Single

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Active Comparator: laser (active laser); 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)	Device: active laser; 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)
Sham Comparator: laser (sham laser); 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)	Device: sham laser; 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)

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Malondialdehyde	oxidative stress indicator	It will be measured after 4 weeks of laser application

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
systolic blood pressure	manual sphygmomanometer	It will be measured after 4 weeks of laser application
diastolic blood pressure	manual sphygmomanometer	It will be measured after 4 weeks of laser application
blood glucose	it will be measured in fasting status	It will be measured after 4 weeks of laser application
erythrocyte sedimentation rate (at first hour)	it will be measured in serum	It will be measured after 4 weeks of laser application
erythrocyte sedimentation rate (at second hour)	it will be measured in serum	It will be measured after 4 weeks of laser application
C reactive protein	it will be measured in serum	It will be measured after 4 weeks of laser application
adenosine triphosphate	it a measure for energy production	It will be measured after 4 weeks of laser application
Nitrate	it will be measured in serum	It will be measured after 4 weeks of laser application
Glutathione	it will be measured in serum	It will be measured after 4 weeks of laser application

Collaborators and Investigators

• Sponsor: Cairo University

Study record dates

Study Major Dates

• Study Start (Actual): October 20, 2022
• Primary Completion (Anticipated): March 30, 2023
• Study Completion (Anticipated): March 30, 2023

Study Registration Dates

• First Submitted: November 20, 2022
• First Submitted That Met QC Criteria: November 20, 2022
• First Posted (Actual): November 30, 2022

Study Record Updates

• Last Update Posted (Actual): November 30, 2022
• Last Update Submitted That Met QC Criteria: November 20, 2022
• Last Verified: November 1, 2022

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Glucose Metabolism Disorders; Metabolic Diseases; Immune System Diseases; Autoimmune Diseases; Endocrine System Diseases; Diabetes Mellitus; Connective Tissue Diseases; Hyperglycemia; Lupus Erythematosus, Systemic; Prediabetic State; Glucose Intolerance
• Other Study ID Numbers: P.T.REC/012/004113

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No