Post Covid SyndromeNCT05271500
New Modality for Post Covid Syndrome Patients
A study testing laser acupuncture in people with Post Covid Syndrome, run by Cairo University.
Trial summary
Coronavirus (19) is a pandemic that affects many countries allover the world. Many patients experienced symptoms as dyspnea and fatigue after their recovery from coronavirus . These symptoms appear to occur regardless the severity of the infection. Read more about this study
- Who is it for?
- Ages 30 to 40 years
- Conditions the study is for
- Post Covid Syndrome
- What is being tested?
- laser acupuncture
- Type of treatment
- Medical device
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 80 participants
- Where
- No sites listed yet
- Study dates
- 15 Mar 2022to 30 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 30 to 40 years
- All sexes
- No healthy volunteers
- Adult
Who may be able to join
- age will be ranged from 30 to 40 years
- patients were diagnosed as covid 19 by polymerase chain reaction test using nasopharyngeal swap
- patients will be negative polymerase chain reaction test (pcr) with symptoms of dyspnea and fatigue.
- patients will be recruited after 2 weeks post the negative pcr
- patients who want to participate and complete the study till the end
Who cannot join
- patients with photosensitivity
- pacemaker plantation pregnant women
- BMI more than 30kg/m2 infection or inflammation at the site of acupuncture laser malignancy uncontrolled diabetes psychiatric disorders or mental retardation
Trial locations and contacts
No sites are listed yet.
About this study
Official title: Effect of Laser Acupuncture on Immunological Response and Dyspnea in Post Covid Syndrome Patients
Coronavirus (19) is a pandemic that affects many countries allover the world. Many patients experienced symptoms as dyspnea and fatigue after their recovery from coronavirus . These symptoms appear to occur regardless the severity of the infection. In addition, many studies reported change in the inflammatory status and immunity in post covid patients. laser acupuncture is a painless noninvasive modality that is used in treating many diseases. laser acupuncture appear to have a role in relieving symptoms, altering inflammatory status and boosting immunity in post covid patients.
- Conditions
- Post Covid Syndrome
- Being tested
- laser acupuncture
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
laser acupunctureDevice
gallium-aluminum arsenide diode laser with a continuous wave and a wavelength of 850nm will be used for laser acupuncture. it will be applied for three times per week for 12 weeks
| Study group | Role | What they receive |
|---|---|---|
| group(1) | Active comparator | 40 post covid 19 patients will receive laser acupuncture Receives: Device: laser acupuncture |
| group(2) | Placebo comparator | 40 post covid patients will receive placebo laser acupuncture in which laser will be off Receives: Device: laser acupuncture |
What is being measured
The primary outcome is the main question the study is designed to answer.
change in the level of CD 3 T cells
5ml of blood will be drawn and serum will be separated. cd3 level will be measured using BD FACS Canto flow cytometer
Measured: after 12 weeks of treatment
change in the level of cd4 T cells
cd4 will be measured using BD FACS Canto flow cytometer after blood sample will be separated
Measured: after 12 weeks of treatment
change in level of interleukin 4
BD FACS Canto flow cytometer with BD CBA human th1/th2 cytokine kit will be used
Measured: after 12 weeks of treatment
change in level of interleukin 6
BD FACS Canto flow cytometer with BD CBA human th1/th2 cytokine kit will be used
Measured: after 12 weeks of treatment
change in lymphocyte count
BD FACS Canto flow cytometer will be used
Measured: after 12 weeks of treatment
change in level of dyspnea
mMRC scale is a five point scale to detect degree of dyspnea while performing physical activity. it is ranged from 0-4
Measured: after 12 weeks of treatment
Secondary outcomes (1)
change in fatigability
chalder fatigue scale is 11 items scale. people of 4 or more are considered meeting the criteria of fatigue
Measured: after 12 weeks of treatment
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted9 Mar 2022
- Study start15 Mar 2022 (estimated)
- Primary completion30 Jun 2022 (estimated)
- Study completion30 Jul 2022 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Post Covid SyndromeStudies 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
- 80 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Cairo University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Salma Ibrahim Abdelmohsen Alghitany, Cairo University
- Investigators
- shawky fouad, PHD degree, Principal investigator, Cairo Universitysandra girguis, PHD degree, Principal investigator, Cairo University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05271500
- Sponsor's protocol ID
- P.T.REC/012/003582
- Status last verified
- Mar 2022
- First submitted
- 7 Mar 2022
- Last updated
- 9 Mar 2022
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 9 Mar 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effect of Laser Acupuncture on Immunological Response and Dyspnea in Post Covid Syndrome Patients
- ClinicalTrials.gov ID
- NCT05271500
- Acronym / sponsor ID
- P.T.REC/012/003582
- Conditions
- Post Covid Syndrome
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 80 participants (estimated)
- Lead sponsor
- Cairo UniversityUniversity, hospital or other
- Study start
- 15 Mar 2022 (estimated)
- Primary completion
- 30 Jun 2022 (estimated)
- Study completion
- 30 Jul 2022 (estimated)
- First posted
- 9 Mar 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.
Coronavirus (19) is a pandemic that affects many countries allover the world. Many patients experienced symptoms as dyspnea and fatigue after their recovery from coronavirus . These symptoms appear to occur regardless the severity of the infection. In addition, many studies reported change in the inflammatory status and immunity in post covid patients. laser acupuncture is a painless noninvasive modality that is used in treating many diseases. laser acupuncture appear to have a role in relieving symptoms, altering inflammatory status and boosting immunity in post covid patients.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| group(1) | Active comparator | Device: laser acupuncture40 post covid 19 patients will receive laser acupuncture |
| group(2) | Placebo comparator | Device: laser acupuncture40 post covid patients will receive placebo laser acupuncture in which laser will be off |
Who may qualify
- Ages
- 30 to 40 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (5 listed)
- age will be ranged from 30 to 40 years
- patients were diagnosed as covid 19 by polymerase chain reaction test using nasopharyngeal swap
- patients will be negative polymerase chain reaction test (pcr) with symptoms of dyspnea and fatigue.
- patients will be recruited after 2 weeks post the negative pcr
- patients who want to participate and complete the study till the end
Key exclusion criteria (3 listed)
- patients with photosensitivity
- pacemaker plantation pregnant women
- BMI more than 30kg/m2 infection or inflammation at the site of acupuncture laser malignancy uncontrolled diabetes psychiatric disorders or mental retardation
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 acupuncturegallium-aluminum arsenide diode laser with a continuous wave and a wavelength of 850nm will be used for laser acupuncture. it will be applied for three times per week for 12 weeks | Device | group(1), group(2) |
Primary outcome
change in the level of CD 3 T cells
Time frame: after 12 weeks of treatment
5ml of blood will be drawn and serum will be separated. cd3 level will be measured using BD FACS Canto flow cytometer
change in the level of cd4 T cells
Time frame: after 12 weeks of treatment
cd4 will be measured using BD FACS Canto flow cytometer after blood sample will be separated
change in level of interleukin 4
Time frame: after 12 weeks of treatment
BD FACS Canto flow cytometer with BD CBA human th1/th2 cytokine kit will be used
change in level of interleukin 6
Time frame: after 12 weeks of treatment
BD FACS Canto flow cytometer with BD CBA human th1/th2 cytokine kit will be used
change in lymphocyte count
Time frame: after 12 weeks of treatment
BD FACS Canto flow cytometer will be used
change in level of dyspnea
Time frame: after 12 weeks of treatment
mMRC scale is a five point scale to detect degree of dyspnea while performing physical activity. it is ranged from 0-4
1 secondary outcome
change in fatigability
Time frame: after 12 weeks of treatment
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 9 Mar 2022.
- Individual participant dataSharing planned: No
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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.
shawky fouad, PHD degree principal investigator
Cairo University
sandra girguis, PHD degree principal investigator
Cairo University
Questions about this trial
What is this clinical trial studying?
A study testing laser acupuncture in people with Post Covid Syndrome, run by Cairo University.
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 5 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: status not confirmed, as of the sponsor's last update on 9 Mar 2022. Status can change between updates, so confirm with the study contact before making plans.
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?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact salma alghitany, PHD degree (00201229723881, fardreams@yahoo.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
change in the level of CD 3 T cells (time frame: after 12 weeks of treatment). The study lists 6 primary outcomes in all. 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 9 Mar 2022; AzTrials last refreshed its copy on 2 Nov 2026.