Systemic Lupus ErythematosusNCT05748899
Effect of Applying Ujjayi Pranayama on Cortisol in Lupus Patients
A study testing Ujjayi pranayama in people with Systemic Lupus Erythematosus, run by Badr University at 1 site in Egypt.
Trial summary
stress vulnerability is very common in lupus patients, specifically women, hence the rates of depression , insomnia, easy fatigue perception, anxiety are high in those women. pranayama is a yogic intervention that may treat the above problems Read more about this study
- Who is it for?
- Ages 35 to 55 years, women only
- Conditions the study is for
- Systemic Lupus Erythematosus
- What is being tested?
- Ujjayi pranayama
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 40 participants
- Where
- 1 siteEgypt
- Study dates
- 15 Dec 2022to 15 Mar 2023
- 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 35 to 55 years
- Women only
- No healthy volunteers
- Adult
Who may be able to join
- 40 lupus women
Who cannot join
- lupus co-morbidities
- illiteracy
Trial locations and contacts
1 site in 1 country.
Egypt1 site, 1 recruiting
- Recruiting
Badr University
Cairo
ahmed elfahl, lecturer, 01001891218, ahmed.elfahl@buc.edu.eg
About this study
stress vulnerability is very common in lupus patients, specifically women, hence the rates of depression , insomnia, easy fatigue perception, anxiety are high in those women. pranayama is a yogic intervention that may treat the above problems
Read the detailed description
lupus patients, specifically 40 women, will divided to group number 1 and group number 2. the women in every group will be 20 women. Group number 1 will receive home-based ujjayi pranayama for six weeks (fifteen minutes in the morning and 15 min in the evening, this training will be online supervised). The group number 2 will not receive Ujjayi pranayama, so it serves as control lupus group
- Conditions
- Systemic Lupus Erythematosus
- Being tested
- Ujjayi pranayama
- 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.
Ujjayi pranayamaBehavioural
this group will receive home-based daily ujjayi pranayama for six weeks (fifteen minutes in the morning and 15 min in the evening, this training will be online supervised).
| Study group | Role | What they receive |
|---|---|---|
| group number 1 | Experimental | Group number 1 will receive home-based daily ujjayi pranayama for six weeks (fifteen minutes in the morning and 15 min in the evening, this training will be online supervised). Receives: Behavioral: Ujjayi pranayama |
| group number 2 | No intervention | The group number 2 will not receive pranayama training, so it serves as control lupus group |
What is being measured
The primary outcome is the main question the study is designed to answer.
serum cortisol
it will be taken from women at morning
Measured: it will be measured after 6 weeks
Secondary outcomes (9)
systolic blood pressure
it will be assessed by manual sphygmomanometer
Measured: it will be measured after 6 weeks
diastolic blood pressure
it will be assessed by manual sphygmomanometer
Measured: it will be measured after 6 weeks
pulse rate
it is number of heart pulsation in minute
Measured: it will be measured after 6 weeks
respiratory rate
it is number of respiration in minute
Measured: it will be measured after 6 weeks
Pittsburgh Sleep Quality Index
it is a questionnaire assessing sleeping quality
Measured: it will be measured after 6 weeks
Fatigue severity scale
it is a questionnaire assessing fatigue severity
Measured: it will be measured after 6 weeks
Beck Depression Inventory
it is a questionnaire assessing depression
Measured: it will be measured after 6 weeks
State Trait Anxiety Inventory
it is a questionnaire assessing Trait Anxiety
Measured: it will be measured after 6 weeks
Stress Vulnerability Scale
it is a questionnaire assessing Stress Vulnerability
Measured: it will be measured after 6 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted1 Mar 2023
- Study start15 Dec 2022
- Primary completion15 Mar 2023 (estimated)
- Study completion15 Mar 2023 (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.
- 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
- 40 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Badr University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Ahmed Mohamed Abdelhalim Elfahl, Badr University
- Investigators
- ahmed elfahl, Principal investigator, Badr University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05748899
- Sponsor's protocol ID
- P.T.REC/012/004288
- Status last verified
- Feb 2023
- First submitted
- 19 Feb 2023
- Last updated
- 1 Mar 2023
- 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 1 Mar 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effect of Applying Ujjayi Pranayama on Cortisol in Lupus Patients
- ClinicalTrials.gov ID
- NCT05748899
- Acronym / sponsor ID
- P.T.REC/012/004288
- Conditions
- Systemic Lupus Erythematosus
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 40 participants (estimated)
- Lead sponsor
- Badr UniversityUniversity, hospital or other
- Study start
- 15 Dec 2022 (actual)
- Primary completion
- 15 Mar 2023 (estimated)
- Study completion
- 15 Mar 2023 (estimated)
- First posted
- 1 Mar 2023 (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.
stress vulnerability is very common in lupus patients, specifically women, hence the rates of depression , insomnia, easy fatigue perception, anxiety are high in those women. pranayama is a yogic intervention that may treat the above problems
Detailed description
lupus patients, specifically 40 women, will divided to group number 1 and group number 2. the women in every group will be 20 women. Group number 1 will receive home-based ujjayi pranayama for six weeks (fifteen minutes in the morning and 15 min in the evening, this training will be online supervised). The group number 2 will not receive Ujjayi pranayama, so it serves as control lupus group
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| group number 1 | Experimental | Behavioral: Ujjayi pranayamaGroup number 1 will receive home-based daily ujjayi pranayama for six weeks (fifteen minutes in the morning and 15 min in the evening, this training will be online supervised). |
| group number 2 | No intervention | –The group number 2 will not receive pranayama training, so it serves as control lupus group |
Who may qualify
- Ages
- 35 to 55 years
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (1 listed)
- 40 lupus women
Key exclusion criteria (2 listed)
- lupus co-morbidities
- illiteracy
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 |
|---|---|---|
| Ujjayi pranayamathis group will receive home-based daily ujjayi pranayama for six weeks (fifteen minutes in the morning and 15 min in the evening, this training will be online supervised). | Behavioural | group number 1 |
Primary outcome
serum cortisol
Time frame: it will be measured after 6 weeks
it will be taken from women at morning
9 secondary outcomes
systolic blood pressure
Time frame: it will be measured after 6 weeks
diastolic blood pressure
Time frame: it will be measured after 6 weeks
pulse rate
Time frame: it will be measured after 6 weeks
respiratory rate
Time frame: it will be measured after 6 weeks
Pittsburgh Sleep Quality Index
Time frame: it will be measured after 6 weeks
Fatigue severity scale
Time frame: it will be measured after 6 weeks
Beck Depression Inventory
Time frame: it will be measured after 6 weeks
State Trait Anxiety Inventory
Time frame: it will be measured after 6 weeks
Stress Vulnerability Scale
Time frame: it will be measured after 6 weeks
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 1 Mar 2023.
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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.
ahmed elfahl principal investigator
Badr 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 Ujjayi pranayama in people with Systemic Lupus Erythematosus, run by Badr 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 1 inclusion and 2 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 1 Mar 2023. 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 mariam El Ebrashy, lecturer (02 01001716570., Mariam.elabrashi@buc.edu.eg), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
serum cortisol (time frame: it will be measured after 6 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 1 Mar 2023.