Inflammatory CytokineNCT06401837
Acupressure Therapy on Post-stroke Fatigue, Depression, and Sleep Disturbances in Ischemic Stroke Patients
A study testing Circadian based acupressure application in people with Inflammatory Cytokine and Circadian Rhythm, run by China Medical University Hospital at 2 sites in Taiwan.
Trial summary
Post-stroke fatigue (PSF) was defined as 'a subjective feeling of physical and/or mental exhaustion that is unrelated to exertion and does not typically improve with rest'. About 25~85% of first stoke patients had PSF in the first year. Read more about this study
- Who is it for?
- Ages 50 to 95 years
- Conditions the study is for
- Inflammatory Cytokine, Circadian Rhythm, Acupressure
- What is being tested?
- Circadian based acupressure application
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 52 participants
- Where
- 2 sitesTaiwan
- Study dates
- 14 Sep 2024to 31 Jul 2025
- 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 50 to 95 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Ages 50 years old and above, both sex.
- Diagnosed with stroke, ischemic.
- Consciousness clear (GCS>=13)
- Stable vital signs and neurological functional status with no or controlled complications (e.g., infection or gastrointestinal bleeding).
- With fatigue (FAS >=24)
Who cannot join
- Severe cognition impairment unable to give consent
- Dysphasia
- Ventilation use
- Multiple diseases with unstable conditions
- Receiving acupuncture therapy with the same acupoints.
Trial locations and contacts
2 sites in 1 country.
Taiwan2 sites
China Medical University Hospital Taichung East Branch
Taichung, Taiwan, 401005
China Medical University Hospital
Taichung, Taiwan, 40447
About this study
Official title: Circadian Based Acupressure Therapy on Post-stroke Fatigue, Depression, and Sleep Disturbances in Ischemic Stroke Patients Undergoing Rehabilitation
Post-stroke fatigue (PSF) was defined as 'a subjective feeling of physical and/or mental exhaustion that is unrelated to exertion and does not typically improve with rest'. About 25~85% of first stoke patients had PSF in the first year. Literature review from animal studies suggested the mechanism of post-stroke fatigue may be due to prolonged production of inflammatory cytokines process after stroke. Acupuncture therapy which regulates the inflammatory process may have the potential to ameliorate fatigue symptoms alone with sleep disturbance after stroke. Acupressure which stimulating the same acupoints by manually pressure may make it easy to perform in anytime and anywhere. The effect of circadian based acupressure application on post-stroke fatigue and sleep disturbances need be further examined. The purpose of this two-year study is to
(1) explore the distribution of inflammatory cytokines (blood and urine IL-1β, IL-6, TNF-α, IL-8) and post-stroke fatigue and sleep, and (2) examine the effect of circadian-based acupressure application on the inflammatory cytokines (urine and blood IL-1β, IL-6, TNF-α, IL-8), and post-stroke symptoms fatigue and sleep) in ischemic stroke patients with post-stroke fatigue during rehabilitation. Ischemic stroke patients (N=240) will be assessed from the rehabilitation wards.
Patients with fatigue (FAS>=24) at assessment (n=78) will be further randomly assigned to the circadian based acupressure application group (AA), or the routine care control group (RC) for 2 weeks. Data of inflammatory cytokines (of IL-1β, IL-6, TNF-α, IL-8), post-stroke fatigue (Fatigue assessment scale), and sleep (Pittsburg Sleep Quality Index and consumer tracker) will be collected. Descriptive statistics, t-test, repeated measure ANOVA, linear/logistic regression or appropriate nonparametric equivalent will be used to compare pre-post differences and to compare differences between groups. Study results will provide information about the mechanism and effect of acupressure application on inflammation and post-stroke fatigue and sleep disturbances in ischemic stroke patients.
Read the detailed description
This is a two-year project. Two groups, randomized controlled experimental design, will be used to examine the effects of circadian-based acupressure application on inflammatory cytokines and post-stroke symptoms (fatigue and sleep) in ischemic stroke patients with fatigue (Figure 3). Ischemic stroke patients with fatigue (FAS >=24) during the first 6 months of rehabilitation, who were screened from the primary assessment, will be randomly assigned to two groups: the circadian-based acupressure application group (AA ) and the routine care control group (RC). Each patient will receive a 2-week intervention according to their group.
Acupressure application (AA) group Patients in the AA group will have the circadian-based acupressure application twice a day, 5 days per week for 2 weeks. Acupressure application will be performed in the morning after one hour of breakfast and in the evening 12 hours before bedtime by a nurse well-trained in Chinese medicine nursing during the first week. Acupoints include three points in hand: PC6, LI4 Hegu, HT7 Shenmen; two points in leg: SP6 Sanyinjiao \& ST36 Zusanli; and one point in back: DU14 Dazhui will be selected. The nurse will also teach patients and their caregivers how to apply acupressure on these acupoints. Self-administered acupressure application on the above acupoints will be performed and followed in the second week. A rehabilitation program and routine care will be scheduled as usual except for acupressure. During nighttime, ambient light will remain dark or dim (<30 lux). Education programs for circadian-based lifestyle and acupressure applications will be provided to patients and caregivers.
Routine care control (RC) group: Patients in the RC group will get routine care as usual for rehabilitation. The ambient light at night will also keep as dark or dim (<30 lux). The same education program for a circadian-based lifestyle as the AA group will also be provided to patients and caregivers.
Outcomes of inflammatory cytokines, post-stroke fatigue, and sleep will be compared during(the 1st week) and after intervention (2nd week) between groups.
- Conditions
- Inflammatory Cytokine, Circadian Rhythm, Acupressure, Post-stroke Fatigue, Sleep, Ischemic Stroke
- Being tested
- Circadian based acupressure application
- Medical subject headings
- Ischemic Stroke
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Circadian based acupressure applicationBehavioural
Acupoints include three points in hand: PC6 Neiguan, LI4 Hegu, HT7 Shenmen; two points in leg: SP6 Sanyinjiao \& ST36 Zusanli; and one point in back: DU14 Dazhui will be selected. The nurse will also teach patients and their caregiver how to apply acupressure on these acupoints. Self-administered acupressure application on the above acupoints will be performed and followed in the second week. A rehabilitation program and routine care will be scheduled as usual except for acupressure.
| Study group | Role | What they receive |
|---|---|---|
| Acupressure application ( AA ) group | Experimental | Patients in the AA group will have the circadian based acupressure application twice a day, 5 days per week for 2 weeks. Acupressure application will be performed in the morning after one hour of breakfast and in the evening 1-2 hour before bedtime by a nurse well-trained with Chinese medicine nursing during the first week. Receives: Behavioral: Circadian based acupressure application |
| Routine care control (RC) group | No intervention | Patients in the RC group will get routine care as usual for rehabilitation. The ambient light at night will keep as dark or dim (<30 lux) as well. The same education program for circadian-based life style as the AA group will be provided to patients and caregivers too. |
What is being measured
The primary outcome is the main question the study is designed to answer.
Inflammatory cytokines
Cytokine concentrations of IL-1β, IL-6, IL-8 and TNF-a were measured in the plasma and urine using the human cytokine LINCO-plex multiplex bead array (Linco Research, St. Charles, MO, USA). The microspheres are incubated with standards, controls and samples in a 96-well microtiter filter plate for 1 h at room temperature. After washing with assay wash buffer, diluted biotinylated secondary antibody was added to the appropriate wells and incubated for 1 h. After washing, streptavidin-phycoerythrin was added to each well and incubated for 30 min. After a final wash, the plate was analyzed using the Luminex 100 analyzer (Luminex Corp., Austin, TX, USA) to determine the concentration of the cytokines.
Measured: 10 cc of urine sample in the morning will be collected from each patient at baseline, and after 2 weeks of intervention.
Sleep
Sleep pattern will be measured by a consumer tracker (Fitbit or Garmin). Patients will wear a tracker on their normal wrist for 24 hours continuously except taking showers. Analysis of sleep pattern will be performed including minute and percentage of total sleep time, awake time, light sleep, deep sleep, and REM sleep. Diary for waking behaviors such as exercise, watching TV, meals, drinks, and time for sun shine etc. and sleeping behaviors such as wake after sleep, will be collected to help analyze sleep patterns. Consumer tracker is show to have appropriate accuracy in measuring sleep (Haghayegh, Khoshnevis, Smolensky, Diller, \& Castriotta, 2019) and mobility (Straiton et al., 2018).
Measured: Patients wear a consumer tracker at baseline, 1st week during intervention, and after 2nd weeks of intervention for 24 hours each.
Sleep quality
The Pittsburgh Sleep Quality Index (PSQI) will be used to assess sleep quality. The PSQI assessed habitual sleep of adults over a 1-month time interval with consists of nineteen self-rated questions that generates seven components: subjective sleep quality, sleep latency, sleep duration, habitual sleep efficiency, sleep disturbances, use of sleeping medication, and daytime dysfunction. A global PSQI score is summed from each component to have a range of 0-21. Higher score indicates worse sleep quality. A post hoc cutoff score of 5 is the cut point to discriminate "good" or "poor" sleeper. The overall Cronbach's alpha values of the global PSQI for examining internal consistency reliability ranged from 0.77-0.83 (Buysse, Reynolds, Monk, Berman, \& Kupfer, 1989; Carpenter \& Andrykowski, 1998; Doi et al., 2000). Sensitivity and specificity of the PSQI ranged from 80%-89.6% and 86.5%-86.6%, respectively (Buysse et al., 1989; Doi et al., 2000; Tsai et al., 2005).
Measured: Patients will fill out the PSQI questionnaire at baseline, 1st week during intervention, and after 2nd weeks of intervention.
Fatigue.
Post-stroke fatigue will be measured by the Fatigue Assessment Scale (FAS) (Michielsen et al., 2003). It consists 10 self-rated descriptors regarding how patient feel with each item scored from one to five (1 = never, 2 = sometimes, 3= regularly, 4= often, 5= always). Items 4 and 10 require reversed scoring. The higher score is associated with higher fatigue with a total score of 10-50. A cut-off of FAS >/=24 gave a sensitivity of 0.84 and specificity of 0.67 in classifying post-stroke fatigue on the FAS (Cumming \& Mead, 2017). Patients will be measured at baseline, 1st weeks during intervention, and after 2nd weeks of intervention.
Measured: Patients will be measured at baseline, 1st weeks during intervention, and after 2nd weeks of intervention.
Secondary outcomes (1)
Depression
A Short Form Geriatric Depression Scale (GDS-15) will be used to assess patients' depression. The GDS-15 consists of 15 questions with 10 indicated the presence of depression when answered positively, while the rest (question numbers 1, 5, 7, 11, 13) indicated depression when answered negatively. Scores of 0-4 are considered normal; 5-8 indicate mild depression; 9-11 indicate moderate depression; and 12-15 indicate severe depression. Participants will be assessed by the GDS-15 at baseline, and after 2nd weeks of intervention. Depression will serve as a covariate in this study.
Measured: Participants will be assessed by the GDS-15 at baseline. Depression will serve as a covariate in this study.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted7 May 2024
- Study start14 Sep 2024
- Primary completion31 Jul 2025
- Study completion31 Jul 2025
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Inflammatory CytokineStudies of the same condition, open and under way.
- More trials run by China Medical University HospitalThe 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
- None (open label)
- Enrolment
- 52 participants (actual)
Sponsor and investigators
- Lead sponsor
- China Medical University Hospital
- Sponsor type
- University, hospital or other
- Collaborators
- National Science and Technology Council
- Responsible party
- Principal investigator, Wen-Chun Liao, China Medical University Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06401837
- Sponsor's protocol ID
- CMUH111-REC2-070
- Status last verified
- Oct 2026
- First submitted
- 2 May 2024
- Last updated
- 2 Nov 2026
- Results posted
- No
- Data monitoring committee
- 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 2 Nov 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Circadian Based Acupressure Therapy on Post-stroke Fatigue, Depression, and Sleep Disturbances in Ischemic Stroke Patients Undergoing Rehabilitation
- ClinicalTrials.gov ID
- NCT06401837
- Acronym / sponsor ID
- CMUH111-REC2-070
- Conditions
- Inflammatory Cytokine, Circadian Rhythm, Acupressure, Post-stroke Fatigue, Sleep, Ischemic Stroke
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 52 participants (actual)
- Lead sponsor
- China Medical University HospitalUniversity, hospital or other
- Collaborators
- National Science and Technology Council
- Study start
- 14 Sep 2024 (actual)
- Primary completion
- 31 Jul 2025 (actual)
- Study completion
- 31 Jul 2025 (actual)
- First posted
- 7 May 2024 (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.
Post-stroke fatigue (PSF) was defined as 'a subjective feeling of physical and/or mental exhaustion that is unrelated to exertion and does not typically improve with rest'. About 25~85% of first stoke patients had PSF in the first year. Literature review from animal studies suggested the mechanism of post-stroke fatigue may be due to prolonged production of inflammatory cytokines process after stroke. Acupuncture therapy which regulates the inflammatory process may have the potential to ameliorate fatigue symptoms alone with sleep disturbance after stroke. Acupressure which stimulating the same acupoints by manually pressure may make it easy to perform in anytime and anywhere. The effect of circadian based acupressure application on post-stroke fatigue and sleep disturbances need be further examined. The purpose of this two-year study is to
(1) explore the distribution of inflammatory cytokines (blood and urine IL-1β, IL-6, TNF-α, IL-8) and post-stroke fatigue and sleep, and (2) examine the effect of circadian-based acupressure application on the inflammatory cytokines (urine and blood IL-1β, IL-6, TNF-α, IL-8), and post-stroke symptoms fatigue and sleep) in ischemic stroke patients with post-stroke fatigue during rehabilitation. Ischemic stroke patients (N=240) will be assessed from the rehabilitation wards.
Patients with fatigue (FAS>=24) at assessment (n=78) will be further randomly assigned to the circadian based acupressure application group (AA), or the routine care control group (RC) for 2 weeks. Data of inflammatory cytokines (of IL-1β, IL-6, TNF-α, IL-8), post-stroke fatigue (Fatigue assessment scale), and sleep (Pittsburg Sleep Quality Index and consumer tracker) will be collected. Descriptive statistics, t-test, repeated measure ANOVA, linear/logistic regression or appropriate nonparametric equivalent will be used to compare pre-post differences and to compare differences between groups. Study results will provide information about the mechanism and effect of acupressure application on inflammation and post-stroke fatigue and sleep disturbances in ischemic stroke patients.
Detailed description
This is a two-year project. Two groups, randomized controlled experimental design, will be used to examine the effects of circadian-based acupressure application on inflammatory cytokines and post-stroke symptoms (fatigue and sleep) in ischemic stroke patients with fatigue (Figure 3). Ischemic stroke patients with fatigue (FAS >=24) during the first 6 months of rehabilitation, who were screened from the primary assessment, will be randomly assigned to two groups: the circadian-based acupressure application group (AA ) and the routine care control group (RC). Each patient will receive a 2-week intervention according to their group.
Acupressure application (AA) group Patients in the AA group will have the circadian-based acupressure application twice a day, 5 days per week for 2 weeks. Acupressure application will be performed in the morning after one hour of breakfast and in the evening 12 hours before bedtime by a nurse well-trained in Chinese medicine nursing during the first week. Acupoints include three points in hand: PC6, LI4 Hegu, HT7 Shenmen; two points in leg: SP6 Sanyinjiao \& ST36 Zusanli; and one point in back: DU14 Dazhui will be selected. The nurse will also teach patients and their caregivers how to apply acupressure on these acupoints. Self-administered acupressure application on the above acupoints will be performed and followed in the second week. A rehabilitation program and routine care will be scheduled as usual except for acupressure. During nighttime, ambient light will remain dark or dim (<30 lux). Education programs for circadian-based lifestyle and acupressure applications will be provided to patients and caregivers.
Routine care control (RC) group: Patients in the RC group will get routine care as usual for rehabilitation. The ambient light at night will also keep as dark or dim (<30 lux). The same education program for a circadian-based lifestyle as the AA group will also be provided to patients and caregivers.
Outcomes of inflammatory cytokines, post-stroke fatigue, and sleep will be compared during(the 1st week) and after intervention (2nd week) between groups.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Acupressure application ( AA ) group | Experimental | Behavioral: Circadian based acupressure applicationPatients in the AA group will have the circadian based acupressure application twice a day, 5 days per week for 2 weeks. Acupressure application will be performed in the morning after one hour of breakfast and in the evening 1-2 hour before bedtime by a nurse well-trained with Chinese medicine nursing during the first week. |
| Routine care control (RC) group | No intervention | –Patients in the RC group will get routine care as usual for rehabilitation. The ambient light at night will keep as dark or dim (<30 lux) as well. The same education program for circadian-based life style as the AA group will be provided to patients and caregivers too. |
Who may qualify
- Ages
- 50 to 95 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- Ages 50 years old and above, both sex.
- Diagnosed with stroke, ischemic.
- Consciousness clear (GCS>=13)
- Stable vital signs and neurological functional status with no or controlled complications (e.g., infection or gastrointestinal bleeding).
- With fatigue (FAS >=24)
Key exclusion criteria (5 listed)
- Severe cognition impairment unable to give consent
- Dysphasia
- Ventilation use
- Multiple diseases with unstable conditions
- Receiving acupuncture therapy with the same acupoints.
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 |
|---|---|---|
| Circadian based acupressure applicationAcupoints include three points in hand: PC6 Neiguan, LI4 Hegu, HT7 Shenmen; two points in leg: SP6 Sanyinjiao \& ST36 Zusanli; and one point in back: DU14 Dazhui will be selected. The nurse will also teach patients and their caregiver how to apply acupressure on these acupoints. Self-administered acupressure application on the above acupoints will be performed and followed in the second week. A rehabilitation program and routine care will be scheduled as usual except for acupressure. | Behavioural | Acupressure application ( AA ) group |
Primary outcome
Inflammatory cytokines
Time frame: 10 cc of urine sample in the morning will be collected from each patient at baseline, and after 2 weeks of intervention.
Cytokine concentrations of IL-1β, IL-6, IL-8 and TNF-a were measured in the plasma and urine using the human cytokine LINCO-plex multiplex bead array (Linco Research, St. Charles, MO, USA). The microspheres are incubated with standards, controls and samples in a 96-well microtiter filter plate for 1 h at room temperature. After washing with assay wash buffer, diluted biotinylated secondary antibody was added to the appropriate wells and incubated for 1 h. After washing, streptavidin-phycoerythrin was added to each well and incubated for 30 min. After a final wash, the plate was analyzed using the Luminex 100 analyzer (Luminex Corp., Austin, TX, USA) to determine the concentration of the cytokines.
Sleep
Time frame: Patients wear a consumer tracker at baseline, 1st week during intervention, and after 2nd weeks of intervention for 24 hours each.
Sleep pattern will be measured by a consumer tracker (Fitbit or Garmin). Patients will wear a tracker on their normal wrist for 24 hours continuously except taking showers. Analysis of sleep pattern will be performed including minute and percentage of total sleep time, awake time, light sleep, deep sleep, and REM sleep. Diary for waking behaviors such as exercise, watching TV, meals, drinks, and time for sun shine etc. and sleeping behaviors such as wake after sleep, will be collected to help analyze sleep patterns. Consumer tracker is show to have appropriate accuracy in measuring sleep (Haghayegh, Khoshnevis, Smolensky, Diller, \& Castriotta, 2019) and mobility (Straiton et al., 2018).
Sleep quality
Time frame: Patients will fill out the PSQI questionnaire at baseline, 1st week during intervention, and after 2nd weeks of intervention.
The Pittsburgh Sleep Quality Index (PSQI) will be used to assess sleep quality. The PSQI assessed habitual sleep of adults over a 1-month time interval with consists of nineteen self-rated questions that generates seven components: subjective sleep quality, sleep latency, sleep duration, habitual sleep efficiency, sleep disturbances, use of sleeping medication, and daytime dysfunction. A global PSQI score is summed from each component to have a range of 0-21. Higher score indicates worse sleep quality. A post hoc cutoff score of 5 is the cut point to discriminate "good" or "poor" sleeper. The overall Cronbach's alpha values of the global PSQI for examining internal consistency reliability ranged from 0.77-0.83 (Buysse, Reynolds, Monk, Berman, \& Kupfer, 1989; Carpenter \& Andrykowski, 1998; Doi et al., 2000). Sensitivity and specificity of the PSQI ranged from 80%-89.6% and 86.5%-86.6%, respectively (Buysse et al., 1989; Doi et al., 2000; Tsai et al., 2005).
Fatigue.
Time frame: Patients will be measured at baseline, 1st weeks during intervention, and after 2nd weeks of intervention.
Post-stroke fatigue will be measured by the Fatigue Assessment Scale (FAS) (Michielsen et al., 2003). It consists 10 self-rated descriptors regarding how patient feel with each item scored from one to five (1 = never, 2 = sometimes, 3= regularly, 4= often, 5= always). Items 4 and 10 require reversed scoring. The higher score is associated with higher fatigue with a total score of 10-50. A cut-off of FAS >/=24 gave a sensitivity of 0.84 and specificity of 0.67 in classifying post-stroke fatigue on the FAS (Cumming \& Mead, 2017). Patients will be measured at baseline, 1st weeks during intervention, and after 2nd weeks of intervention.
1 secondary outcome
Depression
Time frame: Participants will be assessed by the GDS-15 at baseline. Depression will serve as a covariate in this study.
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 2 Nov 2026.
- 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.
The record lists no contact. Use the official record to reach the sponsor.
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Circadian based acupressure application in people with Inflammatory Cytokine and Circadian Rhythm, run by China Medical University Hospital at 2 sites in Taiwan.
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 5 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 2 Nov 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites in Taiwan. 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?
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?
Inflammatory cytokines (time frame: 10 cc of urine sample in the morning will be collected from each patient at baseline, and after 2 weeks of intervention.). The study lists 4 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 2 Nov 2026.