Laser Acupuncture in Egyptian Systemic Lupus Females With Insulin Resistance

Systemic Lupus Erythematosus Clinical Trial

Official title:

Laser Acupuncture in Systemic Lupus Women With Prediabetes

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT05632029
• Other study ID #: P.T.REC/012/004113
• Status: Recruiting
• Phase: N/A
• Start date: October 20, 2022
• Est. completion date: March 30, 2023

Study information

• Verified date: November 2022
• Source: Cairo University
• Contact: Ali Ismail, lecturer
• Phone: 02 01005154209
• Email: ali.mohamed[@]pt.cu.edu.eg
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

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

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)

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 64
• Est. completion date: March 30, 2023
• Est. primary completion date: March 30, 2023
• Accepts healthy volunteers: No
• Gender: Female
• Age group: 18 Years to 50 Years

Eligibility

Inclusion Criteria:

• prediabetic lupus females (n =64)

Exclusion Criteria:

• obesity diabetes heart or respiratory problems

Related Conditions & MeSH terms

• Glucose Intolerance
• Lupus Erythematosus, Systemic
• PreDiabetes
• Prediabetic State
• Systemic Lupus Erythematosus

Intervention

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 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)

Locations

Country	Name	City	State
Egypt	Cairo Unoversity	Giza

Sponsors (1)

Lead Sponsor	Collaborator
Cairo University

Country where clinical trial is conducted

Egypt, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Malondialdehyde	oxidative stress indicator	It will be measured after 4 weeks of laser application
Secondary	systolic blood pressure	manual sphygmomanometer	It will be measured after 4 weeks of laser application
Secondary	diastolic blood pressure	manual sphygmomanometer	It will be measured after 4 weeks of laser application
Secondary	blood glucose	it will be measured in fasting status	It will be measured after 4 weeks of laser application
Secondary	erythrocyte sedimentation rate (at first hour)	it will be measured in serum	It will be measured after 4 weeks of laser application
Secondary	erythrocyte sedimentation rate (at second hour)	it will be measured in serum	It will be measured after 4 weeks of laser application
Secondary	C reactive protein	it will be measured in serum	It will be measured after 4 weeks of laser application
Secondary	adenosine triphosphate	it a measure for energy production	It will be measured after 4 weeks of laser application
Secondary	Nitrate	it will be measured in serum	It will be measured after 4 weeks of laser application
Secondary	Glutathione	it will be measured in serum	It will be measured after 4 weeks of laser application