Systemic Lupus ErythematosusNCT05381545
Laser Puncture and Program of Lifestyle Modification in Lupus Females
A study testing laser puncture, energy expenditure programming, and low-calories recommended diet programming and energy expenditure programming and low-calories recommended diet programming in people with Systemic Lupus Erythematosus, run by Cairo University at 1 site in Egypt.
Trial summary
Serum lipid profile was significantly dysregulated in female systemic lupus erythematosus (SLE) patients Read more about this study
- Who is it for?
- Ages 18 to 50 years, women only
- Conditions the study is for
- Systemic Lupus Erythematosus
- What is being tested?
- laser puncture, energy expenditure programming, and low-calories recommended diet programming and energy expenditure programming and low-calories recommended diet programming
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 64 participants
- Where
- 1 siteEgypt
- Study dates
- 28 Feb 2022to 1 Jul 2022
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 50 years
- Women only
- No healthy volunteers
- Adult
Who may be able to join
- obese female participants
- Lupus females
Who cannot join
- pregnant lupus female
- lactating lupus females
- neurologic or articular disorders
- another autoimmune conditions
Trial locations and contacts
1 site in 1 country.
Egypt1 site, 1 recruiting
- Recruiting
Faculty of Physical Therapy Cairo University
Giza, Dokki
Ali Ismail, lecturer, 02 01005154209, allooka2012@gmail.com
About this study
Official title: Laser Puncture and Program of Lifestyle Modification in Lupus Females: Lipid Profile Response
Serum lipid profile was significantly dysregulated in female systemic lupus erythematosus (SLE) patients
Read the detailed 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.
- Conditions
- Systemic Lupus Erythematosus
- Being tested
- laser puncture, energy expenditure programming, and low-calories recommended diet programming, energy expenditure programming and low-calories recommended diet programming
- Medical subject headings
- Lupus Erythematosus, Systemic
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
laser puncture, energy expenditure programming, and low-calories recommended diet programmingBehavioural
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 programmingBehavioural
This research group will receive, for 12 weeks, energy expenditure program (Pilates exercise, managed 5 times per week) combined with low calorie diet.
| Study group | Role | What they receive |
|---|---|---|
| group A | Experimental | This 32-patient research group will receive, for 12 weeks, energy expenditure program (Pilates exercise, managed 5 times per week, combined with low calorie diet for).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. Receives: Behavioral: laser puncture, energy expenditure programming, and low-calories recommended diet programming |
| Group B | Active comparator | This 32-patient research group will receive, for 12 weeks, energy expenditure program (Pilates exercise, managed 5 times per week, combined with low calorie diet ). Receives: Behavioral: energy expenditure programming and low-calories recommended diet programming |
What is being measured
The primary outcome is the main question the study is designed to answer.
triglycerides
a lipid component will be measured in blood of females
Measured: 12 weeks
Secondary outcomes (3)
high density lipoprotein
a lipid component will be measured in blood of females
Measured: 12 weeks
cholesterol
a lipid component will be measured in blood of females
Measured: 12 weeks
low density lipoprotein
a lipid component will be measured in blood of females
Measured: 12 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted19 May 2022
- Study start28 Feb 2022
- Primary completion1 Jul 2022 (estimated)
- Study completion1 Jul 2022 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Systemic Lupus ErythematosusStudies of the same condition, open and under way.
- More trials run by Cairo UniversityThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 64 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Cairo University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Ali Mohamed Ali ismail, Cairo University
- Investigators
- Ali Ismail, lecturer, Principal investigator, Cairo University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05381545
- Sponsor's protocol ID
- P.T.REC/012/003660
- Status last verified
- May 2022
- First submitted
- 12 May 2022
- Last updated
- 19 May 2022
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 19 May 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Laser Puncture and Program of Lifestyle Modification in Lupus Females: Lipid Profile Response
- ClinicalTrials.gov ID
- NCT05381545
- Acronym / sponsor ID
- P.T.REC/012/003660
- Conditions
- Systemic Lupus Erythematosus
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 64 participants (estimated)
- Lead sponsor
- Cairo UniversityUniversity, hospital or other
- Study start
- 28 Feb 2022 (actual)
- Primary completion
- 1 Jul 2022 (estimated)
- Study completion
- 1 Jul 2022 (estimated)
- First posted
- 19 May 2022 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
Serum lipid profile was significantly dysregulated in female systemic lupus erythematosus (SLE) patients
Detailed 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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| group A | Experimental | Behavioral: laser puncture, energy expenditure programming, and low-calories recommended diet programmingThis 32-patient research group will receive, for 12 weeks, energy expenditure program (Pilates exercise, managed 5 times per week, combined with low calorie diet for).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. |
| Group B | Active comparator | Behavioral: energy expenditure programming and low-calories recommended diet programmingThis 32-patient research group will receive, for 12 weeks, energy expenditure program (Pilates exercise, managed 5 times per week, combined with low calorie diet ). |
Who may qualify
- Ages
- 18 to 50 years
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (2 listed)
- obese female participants
- Lupus females
Key exclusion criteria (4 listed)
- pregnant lupus female
- lactating lupus females
- neurologic or articular disorders
- another autoimmune conditions
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| laser puncture, energy expenditure programming, and low-calories recommended diet programmingThis 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. | Behavioural | group A |
| energy expenditure programming and low-calories recommended diet programmingThis research group will receive, for 12 weeks, energy expenditure program (Pilates exercise, managed 5 times per week) combined with low calorie diet. | Behavioural | Group B |
Primary outcome
triglycerides
Time frame: 12 weeks
a lipid component will be measured in blood of females
3 secondary outcomes
high density lipoprotein
Time frame: 12 weeks
cholesterol
Time frame: 12 weeks
low density lipoprotein
Time frame: 12 weeks
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 19 May 2022.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Ali Ismail, lecturer principal investigator
Cairo University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing laser puncture, energy expenditure programming, and low-calories recommended diet programming and energy expenditure programming and low-calories recommended diet programming in people with Systemic Lupus Erythematosus, run by Cairo University at 1 site in Egypt.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 19 May 2022. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Egypt. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Ali Ismail, lecturer (02 01005154209, allooka2012@gmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
triglycerides (time frame: 12 weeks). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 19 May 2022.