Laser Puncture and Program of Lifestyle Modification in Lupus Females

Systemic Lupus Erythematosus Clinical Trial

Official title:

Laser Puncture and Program of Lifestyle Modification in Lupus Females: Lipid Profile Response

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT05381545
• Other study ID #: P.T.REC/012/003660
• Status: Recruiting
• Phase: N/A
• Start date: February 28, 2022
• Est. completion date: July 1, 2022

Study information

• Verified date: May 2022
• Source: Cairo University
• Contact: Ali Ismail, lecturer
• Phone: 02 01005154209
• Email: allooka2012[@]gmail.com
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

Serum lipid profile was significantly dysregulated in female systemic lupus erythematosus (SLE) patients

Description:

the research will recruit 64 female systemic lupus erythematosus (SLE) obese patients to divide them to two study groups equally. the study groups will receive, for 12 weeks, energy expenditure program (Pilates exercise, managed 5 times per week, combined with low calorie diet for).One group only will receive an additional laser puncture (with 3-time per-week design). The following points will be directly contacted by laser, for two minutes: GB34&28, ST25&36&40, SP6, and CV4&9&12.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 64
• Est. completion date: July 1, 2022
• Est. primary completion date: July 1, 2022
• Accepts healthy volunteers: No
• Gender: Female
• Age group: 18 Years to 50 Years

Eligibility

Inclusion Criteria:

• obese female participants

• Lupus females

Exclusion Criteria:

• pregnant lupus female

• lactating lupus females

• neurologic or articular disorders

• another autoimmune conditions

Related Conditions & MeSH terms

• Lupus Erythematosus, Systemic
• Systemic Lupus Erythematosus

Intervention

Behavioral:
• laser puncture, energy expenditure programming, and low-calories recommended diet programming
This research group will receive, for 12 weeks, energy expenditure program (Pilates exercise, managed 5 times per week) combined with low calorie diet .This research group will receive an additional laser puncture (with 3-time per-week design). The following points will be directly contacted by laser, for two minutes: GB34&28, ST25&36&40, SP6, and CV4&9&12.
• energy expenditure programming and low-calories recommended diet programming
This research group will receive, for 12 weeks, energy expenditure program (Pilates exercise, managed 5 times per week) combined with low calorie diet.

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	triglycerides	a lipid component will be measured in blood of females	12 weeks
Secondary	high density lipoprotein	a lipid component will be measured in blood of females	12 weeks
Secondary	cholesterol	a lipid component will be measured in blood of females	12 weeks
Secondary	low density lipoprotein	a lipid component will be measured in blood of females	12 weeks