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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT04970199
Other study ID # P.T.REC/012/003252
Secondary ID
Status Completed
Phase N/A
First received
Last updated
Start date July 12, 2021
Est. completion date November 30, 2021

Study information

Verified date January 2022
Source Cairo University
Contact n/a
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial 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.


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


Recruitment information / eligibility

Status Completed
Enrollment 60
Est. completion date November 30, 2021
Est. primary completion date November 10, 2021
Accepts healthy volunteers No
Gender Female
Age group 18 Years to 47 Years
Eligibility Inclusion Criteria: - lupus females - 60 patients Exclusion Criteria: - pregnancy - cardiovascular diseases - respiratory diseases

Study Design


Intervention

Device:
laser application on acupoints
laser acupuncture

Locations

Country Name City State
Egypt Faculty of Physical Therapy Cairo University Giza Dokki

Sponsors (1)

Lead Sponsor Collaborator
Cairo University

Country where clinical trial is conducted

Egypt, 

Outcome

Type Measure Description Time frame Safety issue
Primary Malondialdehyde anti-oxidative stress factor It was measured after 4 weeks
Secondary systole blood pressure It was measured after 4 weeks
Secondary diastole blood pressure It was measured after 4 weeks
Secondary blood glucose fasting It was be measured after 4 weeks
Secondary erythrocyte sedimentation rate (1 hour) inflammatory marker It was measured after 4 weeks
Secondary erythrocyte sedimentation rate (2 hour) inflammatory marker It was measured after 4 weeks
Secondary c reactive protein inflammatory marker It was measured after 4 weeks
Secondary adenosine triphosphate energy production marker It was measured after 4 weeks
Secondary Nitrate oxidative stress factor It was measured after 4 weeks
Secondary Glutathione antioxidant marker It was measured after 4 weeks
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