System; Lupus ErythematosusNCT04970199
Cardiovascular Protective Role of Laser Acupuncture in Systemic Lupus
A study testing laser application on acupoints in people with System; Lupus Erythematosus, run by Cairo University at 1 site in Egypt.
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 … Read more about this study
- Who is it for?
- Ages 18 to 47 years, women only
- Conditions the study is for
- System; Lupus Erythematosus
- What is being tested?
- laser application on acupoints
- Type of treatment
- Medical device
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 60 participants
- Where
- 1 siteEgypt
- Study dates
- 12 Jul 2021to 30 Nov 2021
- 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 47 years
- Women only
- No healthy volunteers
- Adult
Who may be able to join
- lupus females
- 60 patients
Who cannot join
- pregnancy
- cardiovascular diseases
- respiratory diseases
Trial locations and contacts
1 site in 1 country.
About this study
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.
Read the detailed 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
- Conditions
- System; Lupus Erythematosus
- Being tested
- laser application on acupoints
- 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 application on acupointsDevice
laser acupuncture
| Study group | Role | What they receive |
|---|---|---|
| group 1 | Active comparator | thirty lupus women received 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 was applied for 1 min on every acupiont). Receives: Device: laser application on acupoints |
| group 2 | Sham comparator | thirty lupus women received laser acupuncture (sham) for one month (3 days) 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 was be applied for 1 min on every acupiont). Receives: Device: laser application on acupoints |
What is being measured
The primary outcome is the main question the study is designed to answer.
Malondialdehyde
anti-oxidative stress factor
Measured: It was measured after 4 weeks
Secondary outcomes (9)
systole
blood pressure
Measured: It was measured after 4 weeks
diastole
blood pressure
Measured: It was measured after 4 weeks
blood glucose
fasting
Measured: It was be measured after 4 weeks
erythrocyte sedimentation rate (1 hour)
inflammatory marker
Measured: It was measured after 4 weeks
erythrocyte sedimentation rate (2 hour)
inflammatory marker
Measured: It was measured after 4 weeks
c reactive protein
inflammatory marker
Measured: It was measured after 4 weeks
adenosine triphosphate
energy production marker
Measured: It was measured after 4 weeks
Nitrate
oxidative stress factor
Measured: It was measured after 4 weeks
Glutathione
antioxidant marker
Measured: It was measured after 4 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted21 Jul 2021
- Study start12 Jul 2021
- Primary completion10 Nov 2021
- Study completion30 Nov 2021
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for System; 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
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Participant, Outcomes assessor
- Enrolment
- 60 participants (actual)
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
- NCT04970199
- Sponsor's protocol ID
- P.T.REC/012/003252
- Status last verified
- Jan 2022
- First submitted
- 11 Jul 2021
- Last updated
- 28 Jan 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 28 Jan 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Cardiovascular Protective Role of Laser Acupuncture in Systemic Lupus
- ClinicalTrials.gov ID
- NCT04970199
- Acronym / sponsor ID
- P.T.REC/012/003252
- Conditions
- System; Lupus Erythematosus
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 60 participants (actual)
- Lead sponsor
- Cairo UniversityUniversity, hospital or other
- Study start
- 12 Jul 2021 (actual)
- Primary completion
- 10 Nov 2021 (actual)
- Study completion
- 30 Nov 2021 (actual)
- First posted
- 21 Jul 2021 (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.
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.
Detailed 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
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| group 1 | Active comparator | Device: laser application on acupointsthirty lupus women received 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 was applied for 1 min on every acupiont). |
| group 2 | Sham comparator | Device: laser application on acupointsthirty lupus women received laser acupuncture (sham) for one month (3 days) 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 was be applied for 1 min on every acupiont). |
Who may qualify
- Ages
- 18 to 47 years
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (2 listed)
- lupus females
- 60 patients
Key exclusion criteria (3 listed)
- pregnancy
- cardiovascular diseases
- respiratory diseases
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 application on acupointslaser acupuncture | Device | group 1, group 2 |
Primary outcome
Malondialdehyde
Time frame: It was measured after 4 weeks
anti-oxidative stress factor
9 secondary outcomes
systole
Time frame: It was measured after 4 weeks
diastole
Time frame: It was measured after 4 weeks
blood glucose
Time frame: It was be measured after 4 weeks
erythrocyte sedimentation rate (1 hour)
Time frame: It was measured after 4 weeks
erythrocyte sedimentation rate (2 hour)
Time frame: It was measured after 4 weeks
c reactive protein
Time frame: It was measured after 4 weeks
adenosine triphosphate
Time frame: It was measured after 4 weeks
Nitrate
Time frame: It was measured after 4 weeks
Glutathione
Time frame: It was measured after 4 weeks
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 28 Jan 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 application on acupoints in people with System; 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 3 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: finished, as of the sponsor's last update on 28 Jan 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. Some participants in this study may receive a placebo. 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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Malondialdehyde (time frame: It was measured after 4 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 28 Jan 2022.