Sepsis Induced Myocardial DysfunctionPhase 2YQSIMDNCT06686355
The Treatment of Sepsis Induced Myocardial Dysfunction With Yiqilishui Formula
A Phase 2 study testing Yiqilishui formula in people with Sepsis Induced Myocardial Dysfunction, run by Dongzhimen Hospital, Beijing at 1 site in China.
Trial summary
The goal of this clinical trial is to learn if Chinese medicine - Yiqilishui formula works to treat sepsis-induced myocardial dysfunction (SIMD). It will also learn about the safety of Yiqilishui formula. Read more about this study
- Who is it for?
- Ages 50 to 85 years
- Conditions the study is for
- Sepsis Induced Myocardial Dysfunction
- What is being tested?
- Yiqilishui formula
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 80 participants
- Where
- 1 siteChina
- Study dates
- 20 Nov 2024to 31 Dec 2026
- Phase
- Phase 2
- Are there results?
- Not yet: the study is under way
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 85 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Patients hospitalized in the ICU of Tongzhou Traditional Chinese Medicine Hospital and Dongzhimen Hospital of Beijing University of Chinese Medicine between January 2024 and December 2026.
- Patients diagnosed with SIMD and qi deficiency and water flooding syndrome.
- Aged 50 to 85 years.
- SOFA score: 2 to 12 points.
- Diagnosis of SIMD within 24 hours.
- Signed informed consent by the patient or their family.
Who cannot join
- Subjects diagnosed with acute coronary syndrome.
- Subjects with heart failure caused by cardiomyopathies such as hypertrophic cardiomyopathy, dilated cardiomyopathy, myocardial amyloidosis, diabetic cardiomyopathy, or hypothyroid cardiomyopathy.
- Subjects with heart failure caused by structural heart abnormalities, arrhythmias, pulmonary heart disease, or cardiorenal syndrome.
- Subjects with severe primary diseases affecting survival, including uncontrolled, unresectable metastatic malignant tumors, hematologic diseases, and HIV.
- Subjects with liver or kidney dysfunction, with an individual SOFA score of ≥3 for liver or kidney function.
- Subjects who have used immunosuppressants continuously in the last 6 months or have undergone organ transplantation.
Show all 12Show fewer
- Subjects who have used corticosteroids (equivalent to methylprednisolone ≥20mg/day) continuously within 7 days prior to enrollment.
- Subjects who have used Chinese herbal medicines or Chinese patent medicine replenishing qi, activating blood circulation and facilitating diuresis within 14 days prior to enrollment.
- Subjects deemed unable to take decoctions by clinicians.
- Pregnant or breastfeeding women.
- Subjects who have participated in other clinical trials within the last 30 days.
- Subjects deemed unable to complete or unsuitable for this study by the researchers (e.g., expected death within 48 hours or refusal of active treatment).
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
China1 site, 1 recruiting
- Recruiting
Dongzhimen Hospital Affiliated to Beijing University of Chinese Medicine
Beijing, 100007
Guoxia Zhang, 86-84013192, 2721064904@qq.com
About this study
Official title: Double-blind Randomized Parallel Contrast Clinical Study of Yiqilishui Formula on Sepsis Induced Myocardial Dysfunction
The goal of this clinical trial is to learn if Chinese medicine - Yiqilishui formula works to treat sepsis-induced myocardial dysfunction (SIMD). It will also learn about the safety of Yiqilishui formula. The main questions it aims to answer are:
- Compared with conventional western traetment alone, can supplementing conventional Western treatment with Yiqilishui formula better improve the heart function and reduce mortality of participants with SIMD?
- What medical problems do participants have when taking Yiqilishui formula? Researchers will compare Yiqilishui formula to a placebo (a look-alike substance that contains no drug) to see if Yiqilishui formula works to treat SIMD.
Read more
Participants will:
- Take Yiqilishui formula granules or placebo twice daily for 7 days, while receiving standard conventional Western treatment.
- Undergo blood drawing, electrocardiogram and transthoracic echocardiography at enrollment, on the 3rd day, the 7th day, and the 14th day after enrollment.
Read the detailed description
Sepsis-induced myocardial dysfunction (SIMD) is characterized by high morbidity and mortality rates and remains a challenging issue in the field of critical care that has not yet been resolved. The main pathogenesis involves deficiency of Qi with water overflow and blood stasis and toxin blocking the channels. The use of a Qi-invigorating and diuretic formula has the effect of invigorating Qi, promoting diuresis, and detoxifying and unblocking the channels. This study employed a two-center prospective parallel randomized double-blind controlled trial, selecting a total of 80 SIMD subjects from the ICU of Tongzhou District Traditional Chinese Medicine Hospital and the ICU of Dongzhimen Hospital of Beijing University of Chinese Medicine, who met the inclusion and exclusion criteria. The subjects were randomly and evenly divided into a treatment group and a control group. Both groups received basic SIMD treatment, with the treatment group additionally receiving the oral or nasogastric administration of a granule preparation of Yiqilishui formula, and the control group receiving a placebo orally or nasogastrically. The intervention period was 7 days, with a follow-up period of 28 days. The primary efficacy indicators compared between the two groups were BNP and NT-proBNP, and the secondary efficacy indicators were echocardiography, myocardial injury markers, inflammatory markers, critical illness severity scores, ICU length of stay and costs, and 28-day survival rate. The study aimed to evaluate the clinical efficacy and safety of the Yiqilishui formula for SIMD.
- Conditions
- Sepsis Induced Myocardial Dysfunction
- Being tested
- Yiqilishui formula, Placebo
- Keywords
- sepsis, myocardial dysfunction, SIMD, Yiqilishui formula, Double-blind randomized, clinical study
- Medical subject headings
- Sepsis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Yiqilishui formulaDrug
Astragalus Root 30g, Angelica sinensis 30g, Honeysuckle Flower 30g, Capillary Artemisia Herb 15g, Giant Knotweed Rhizome 15g, Lepidium Seed 30g, Sichuan Lovage Rhizome 15g, Salvia Root 15g, Jujube Fruit 15g;
PlaceboOther
5% Yiqilishui Granules + 95% Dextrin;
| Study group | Role | What they receive |
|---|---|---|
| Yiqilishui group | Experimental | Conventional Western medicine treatment + oral or nasogastric administration of Yiqilishui formula granules, twice daily; Receives: Drug: Yiqilishui formula |
| placebo group | Sham comparator | Conventional Western medicine treatment + oral or nasal feeding of Yiqilishui formula placebo , twice daily. Receives: Other: Placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
BNP（B-type natriuretic peptide） decline rate
Blood samples were taken from the median cubital vein of the subjects at enrollment, on the 3rd day, the 7th day, and the 14th day to measure the BNP levels in the subjects' venous blood, calculate the patient's BNP decline rate, assess the severity of heart failure in the subjects, and predict their prognosis.
Measured: At enrollment, on the 3rd day, the 7th day, and the 14th day
Secondary outcomes (19)
The levels of cTnI
Cardiac injury markers-Blood samples from the median cubital vein of the subjects were taken at enrollment, on the 3rd day, the 7th day, and the 14th day to detect the levels of cardiac troponin I (cTnI)
Measured: At enrollment, on the 3rd day, the 7th day, and the 14th day
The levels of CK-MB
Cardiac injury markers-Blood samples from the median cubital vein of the subjects were taken at enrollment, on the 3rd day, the 7th day, and the 14th day to detect the levels of creatine kinase MB isoenzyme
Measured: At enrollment, on the 3rd day, the 7th day, and the 14th day
Concentration of H-FABP
Cardiac injury markers-Blood samples from the median cubital vein of the subjects were taken at enrollment, on the 3rd day, the 7th day, and the 14th day to detect the levels of heart-type fatty acid-binding protein
Measured: At enrollment, on the 3rd day, the 7th day, and the 14th day
Tei index
At the time of subject enrollment, on the 3rd day, 7th day, and 14th day, Tei index were measured using transthoracic echocardiography to evaluate the subjects' cardiac function and structure.
Measured: At enrollment, on the 3rd day, the 7th day, and the 14th day
MEE
At the time of subject enrollment, on the 3rd day, 7th day, and 14th day, myocardial energy expenditure
Measured: At enrollment, on the 3rd day, the 7th day, and the 14th day
LVMI
At the time of subject enrollment, on the 3rd day, 7th day, and 14th day, left ventricular mass index (LVMI) were measured using transthoracic echocardiography to evaluate the subjects' cardiac function and structure.
Measured: At enrollment, on the 3rd day, the 7th day, and the 14th day
The levels of WBC
Blood is drawn from the median cubital vein of the subjects at enrollment, on the 3rd day, the 7th day, and the 14th day. The levels of white blood cells (WBC) in the subjects' venous blood is detected.
Measured: At enrollment, on the 3rd day, the 7th day, and the 14th day
The percentage of NE%
Blood is drawn from the median cubital vein of the subjects at enrollment, on the 3rd day, the 7th day, and the 14th day. The percentage of neutrophils (NE%) in the subjects' venous blood is detected.
Measured: At enrollment, on the 3rd day, the 7th day, and the 14th day
The levels of CRP
Blood is drawn from the median cubital vein of the subjects at enrollment, on the 3rd day, the 7th day, and the 14th day. The levels of C-reactive protein (CRP) in the subjects' venous blood is detected.
Measured: At enrollment, on the 3rd day, the 7th day, and the 14th day
The levels of PCT
Blood is drawn from the median cubital vein of the subjects at enrollment, on the 3rd day, the 7th day, and the 14th day. The levels of procalcitonin (PCT) in the subjects' venous blood is detected.
Measured: At enrollment, on the 3rd day, the 7th day, and the 14th day
Concentration of IL-6
The supernatant serum is obtained by centrifugation, and the levels of interleukin-6 (IL-6) is measured by ELISA.
Measured: At enrollment, on the 3rd day, the 7th day, and the 14th day
Concentration of TNF-α
The supernatant serum is obtained by centrifugation, and the levels of tumor necrosis factor-α (TNF-α) is measured by ELISA.
Measured: At enrollment, on the 3rd day, the 7th day, and the 14th day
Concentration of ROS
The supernatant serum is obtained by centrifugation, and reactive oxygen species (ROS)is measured by ELISA.
Measured: At enrollment, on the 3rd day, the 7th day, and the 14th day
Concentration of ATP
The supernatant serum is obtained by centrifugation, and the levels of ATP content in the subjects' serum is measured by ELISA.
Measured: At enrollment, on the 3rd day, the 7th day, and the 14th day
Platelet aggregation rate
At enrollment, D3, D7, and D14, venous blood from patients is collected, platelet-rich plasma is prepared using differential centrifugation, and the platelet aggregation rate is determined by optical turbidimetry.
Measured: At enrollment, on the 3rd day, the 7th day, and the 14th day
SOFA score
Sequential Organ Failure Assessment (SOFA score) is performed at the time of enrollment, on the 7th day, and on the 14th day. The SOFA score includes six systems: respiratory, circulation, liver, coagulation, kidney and central nervous system. Each system is scored according to different variables, with a score of 0 to 4 points, and a total score of 0 to 24 points. The higher the score, the worse the outcome.
Measured: At enrollment, the 7th day, and the 14th day
Apache II score
Acute Physiology and Chronic Health Evaluation (Apache II score) is performed at the time of enrollment, on the 7th day, and on the 14th day. The Apache II score is scored from 0 to 71, and the higher the score, the worse the outcome.
Measured: At enrollment, the 7th day, and the 14th day
ICU length of stay;
ICU length of stay，up to 100 weeks.
Measured: From the date the participant is transferred to the ICU to the date he or she is finally transferred out of the ICU, assessed up to 100 weeks.
Outcome indicator
28-day mortality rate
Measured: 28th day
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted13 Nov 2024
- Study start20 Nov 2024
- Primary completion31 Dec 2026 (estimated)
- Study completion31 Dec 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Sepsis Induced Myocardial DysfunctionStudies 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 2
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- Inclusion criteria: 1. Patients hospitalized in the ICU of Beijing Tongzhou Traditional Chinese Medicine Hospital and the ICU of Dongzhimen Hospital of Beijing University of Traditional Chinese Medicine from January 2024 to December 2026. 2. Meeting the diagnostic criteria for Qi deficiency and water overflow syndrome of septic cardiomyopathy. 3. Age ≥50 and ≤85 years old; 4. SOFA score: 2 to 12 points; 5. Diagnosis of septic cardiomyopathy within 24 hours; 6. Patient or family member has signed the informed consent form.
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 80 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Dongzhimen Hospital, Beijing
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Xiu Shengyao, Dongzhimen Hospital, Beijing
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06686355
- Sponsor's protocol ID
- DongzhimenH
- Acronym
- YQSIMD
- Status last verified
- Mar 2026
- First submitted
- 9 Oct 2024
- Last updated
- 30 Mar 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 30 Mar 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Double-blind Randomized Parallel Contrast Clinical Study of Yiqilishui Formula on Sepsis Induced Myocardial Dysfunction
- ClinicalTrials.gov ID
- NCT06686355
- Acronym / sponsor ID
- YQSIMD / DongzhimenH
- Conditions
- Sepsis Induced Myocardial Dysfunction
- Keywords
- sepsis, myocardial dysfunction, SIMD, Yiqilishui formula, Double-blind randomized, clinical study
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 80 participants (estimated)
- Lead sponsor
- Dongzhimen Hospital, BeijingUniversity, hospital or other
- Study start
- 20 Nov 2024 (actual)
- Primary completion
- 31 Dec 2026 (estimated)
- Study completion
- 31 Dec 2026 (estimated)
- First posted
- 13 Nov 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.
The goal of this clinical trial is to learn if Chinese medicine - Yiqilishui formula works to treat sepsis-induced myocardial dysfunction (SIMD). It will also learn about the safety of Yiqilishui formula. The main questions it aims to answer are:
- Compared with conventional western traetment alone, can supplementing conventional Western treatment with Yiqilishui formula better improve the heart function and reduce mortality of participants with SIMD?
- What medical problems do participants have when taking Yiqilishui formula? Researchers will compare Yiqilishui formula to a placebo (a look-alike substance that contains no drug) to see if Yiqilishui formula works to treat SIMD.
Participants will:
- Take Yiqilishui formula granules or placebo twice daily for 7 days, while receiving standard conventional Western treatment.
- Undergo blood drawing, electrocardiogram and transthoracic echocardiography at enrollment, on the 3rd day, the 7th day, and the 14th day after enrollment.
Detailed description
Sepsis-induced myocardial dysfunction (SIMD) is characterized by high morbidity and mortality rates and remains a challenging issue in the field of critical care that has not yet been resolved. The main pathogenesis involves deficiency of Qi with water overflow and blood stasis and toxin blocking the channels. The use of a Qi-invigorating and diuretic formula has the effect of invigorating Qi, promoting diuresis, and detoxifying and unblocking the channels. This study employed a two-center prospective parallel randomized double-blind controlled trial, selecting a total of 80 SIMD subjects from the ICU of Tongzhou District Traditional Chinese Medicine Hospital and the ICU of Dongzhimen Hospital of Beijing University of Chinese Medicine, who met the inclusion and exclusion criteria. The subjects were randomly and evenly divided into a treatment group and a control group. Both groups received basic SIMD treatment, with the treatment group additionally receiving the oral or nasogastric administration of a granule preparation of Yiqilishui formula, and the control group receiving a placebo orally or nasogastrically. The intervention period was 7 days, with a follow-up period of 28 days. The primary efficacy indicators compared between the two groups were BNP and NT-proBNP, and the secondary efficacy indicators were echocardiography, myocardial injury markers, inflammatory markers, critical illness severity scores, ICU length of stay and costs, and 28-day survival rate. The study aimed to evaluate the clinical efficacy and safety of the Yiqilishui formula for SIMD.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 2
- Model description
- Inclusion criteria: 1. Patients hospitalized in the ICU of Beijing Tongzhou Traditional Chinese Medicine Hospital and the ICU of Dongzhimen Hospital of Beijing University of Traditional Chinese Medicine from January 2024 to December 2026. 2. Meeting the diagnostic criteria for Qi deficiency and water overflow syndrome of septic cardiomyopathy. 3. Age ≥50 and ≤85 years old; 4. SOFA score: 2 to 12 points; 5. Diagnosis of septic cardiomyopathy within 24 hours; 6. Patient or family member has signed the informed consent form.
| Arm | Type | Receives |
|---|---|---|
| Yiqilishui group | Experimental | Drug: Yiqilishui formulaConventional Western medicine treatment + oral or nasogastric administration of Yiqilishui formula granules, twice daily; |
| placebo group | Sham comparator | Other: PlaceboConventional Western medicine treatment + oral or nasal feeding of Yiqilishui formula placebo , twice daily. |
Who may qualify
- Ages
- 50 to 85 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (6 listed)
- Patients hospitalized in the ICU of Tongzhou Traditional Chinese Medicine Hospital and Dongzhimen Hospital of Beijing University of Chinese Medicine between January 2024 and December 2026.
- Patients diagnosed with SIMD and qi deficiency and water flooding syndrome.
- Aged 50 to 85 years.
- SOFA score: 2 to 12 points.
- Diagnosis of SIMD within 24 hours.
Key exclusion criteria (12 listed)
- Subjects diagnosed with acute coronary syndrome.
- Subjects with heart failure caused by cardiomyopathies such as hypertrophic cardiomyopathy, dilated cardiomyopathy, myocardial amyloidosis, diabetic cardiomyopathy, or hypothyroid cardiomyopathy.
- Subjects with heart failure caused by structural heart abnormalities, arrhythmias, pulmonary heart disease, or cardiorenal syndrome.
- Subjects with severe primary diseases affecting survival, including uncontrolled, unresectable metastatic malignant tumors, hematologic diseases, and HIV.
- Subjects with liver or kidney dysfunction, with an individual SOFA score of ≥3 for liver or kidney function.
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 |
|---|---|---|
| Yiqilishui formulaAstragalus Root 30g, Angelica sinensis 30g, Honeysuckle Flower 30g, Capillary Artemisia Herb 15g, Giant Knotweed Rhizome 15g, Lepidium Seed 30g, Sichuan Lovage Rhizome 15g, Salvia Root 15g, Jujube Fruit 15g; | Drug | Yiqilishui group |
| Placebo5% Yiqilishui Granules + 95% Dextrin; | Other | placebo group |
Primary outcome
BNP（B-type natriuretic peptide） decline rate
Time frame: At enrollment, on the 3rd day, the 7th day, and the 14th day
Blood samples were taken from the median cubital vein of the subjects at enrollment, on the 3rd day, the 7th day, and the 14th day to measure the BNP levels in the subjects' venous blood, calculate the patient's BNP decline rate, assess the severity of heart failure in the subjects, and predict their prognosis.
19 secondary outcomes
The levels of cTnI
Time frame: At enrollment, on the 3rd day, the 7th day, and the 14th day
The levels of CK-MB
Time frame: At enrollment, on the 3rd day, the 7th day, and the 14th day
Concentration of H-FABP
Time frame: At enrollment, on the 3rd day, the 7th day, and the 14th day
Tei index
Time frame: At enrollment, on the 3rd day, the 7th day, and the 14th day
MEE
Time frame: At enrollment, on the 3rd day, the 7th day, and the 14th day
LVMI
Time frame: At enrollment, on the 3rd day, the 7th day, and the 14th day
The levels of WBC
Time frame: At enrollment, on the 3rd day, the 7th day, and the 14th day
The percentage of NE%
Time frame: At enrollment, on the 3rd day, the 7th day, and the 14th day
The levels of CRP
Time frame: At enrollment, on the 3rd day, the 7th day, and the 14th day
The levels of PCT
Time frame: At enrollment, on the 3rd day, the 7th day, and the 14th day
Concentration of IL-6
Time frame: At enrollment, on the 3rd day, the 7th day, and the 14th day
Concentration of TNF-α
Time frame: At enrollment, on the 3rd day, the 7th day, and the 14th day
Concentration of ROS
Time frame: At enrollment, on the 3rd day, the 7th day, and the 14th day
Concentration of ATP
Time frame: At enrollment, on the 3rd day, the 7th day, and the 14th day
Platelet aggregation rate
Time frame: At enrollment, on the 3rd day, the 7th day, and the 14th day
SOFA score
Time frame: At enrollment, the 7th day, and the 14th day
Apache II score
Time frame: At enrollment, the 7th day, and the 14th day
ICU length of stay;
Time frame: From the date the participant is transferred to the ICU to the date he or she is finally transferred out of the ICU, assessed up to 100 weeks.
Outcome indicator
Time frame: 28th day
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 30 Mar 2026.
- Individual participant dataSharing planned: Yes
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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.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing Yiqilishui formula in people with Sepsis Induced Myocardial Dysfunction, run by Dongzhimen Hospital, Beijing at 1 site in China.
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 6 inclusion and 12 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: looking for participants now, as of the sponsor's last update on 30 Mar 2026. 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 China. 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.
What does this phase mean?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Guoxia Zhang (+86-010-84013192, 2721064904@qq.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
BNP（B-type natriuretic peptide） decline rate (time frame: At enrollment, on the 3rd day, the 7th day, and the 14th day). 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 30 Mar 2026.