Type 2 Diabetes MellitusNCT07775664
Huangqi Gegen Decoction for Endothelial Function in Type 2 Diabetes at Very High ASCVD Risk
A study testing Huangqi Gegen Decoction Granules and Conventional Treatment in people with Type 2 Diabetes Mellitus and Endothelial Dysfunction, run by Putuo Hospital, Shanghai University of Traditional Chinese Medicine at 1 site in China.
Trial summary
This clinical trial evaluates whether Huangqi Gegen Decoction can improve blood vessel function in adults with type 2 diabetes mellitus who are at very high risk of atherosclerotic cardiovascular disease and meet the traditional Chinese medicine criteria for Qi-Yin deficiency syndrome. Read more about this study
- Who is it for?
- Ages 18 to 75 years
- Conditions the study is for
- Type 2 Diabetes Mellitus, Endothelial Dysfunction, Cardiovascular Risk
- What is being tested?
- Huangqi Gegen Decoction Granules and Conventional Treatment
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 90 participants
- Where
- 1 siteChina
- Study dates
- 4 Aug 2026to 30 Oct 2026
- Phase
- Interventional
- 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 18 to 75 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Aged 18 to 75 years.
- Diagnosed with type 2 diabetes mellitus, with fasting plasma glucose <9.0 mmol/L and glycated hemoglobin (HbA1c) <8.5%, and receiving a stable glucose-lowering treatment regimen without adjustment during the previous 3 months.
- Type 2 diabetes mellitus with target-organ damage or at least 3 additional cardiovascular risk factors.
- Meets the diagnostic criteria for Qi-Yin deficiency syndrome in traditional Chinese medicine, including: (a) primary symptoms of dry mouth and thirst, palpitations, and shortness of breath; (b) secondary symptoms including spontaneous sweating, fatigue, chest tightness, chest discomfort or pain, heat sensation in the palms and soles, polyuria, or constipation; and (c) dark-red tongue and weak, thready pulse. The diagnosis requires at least 2 primary symptoms together with supporting secondary symptoms and tongue/pulse findings, and must be confirmed by at least 2 traditional Chinese medicine physicians at attending-physician level or above.
- Voluntarily participates in the study and provides written informed consent.
- Has received stable conventional treatment for at least 3 months before enrollment, with the treatment regimen consistent with relevant Chinese clinical guidelines for diabetes and chronic coronary syndromes.
Who cannot join
- Allergy to the traditional Chinese medicines used in the study or a history of multiple drug allergies.
- History of severe arrhythmia, including recurrent or symptomatic ventricular tachycardia or atrial fibrillation with rapid ventricular response, or New York Heart Association (NYHA) functional class III-IV heart failure.
- Abnormal thyroid function, including hyperthyroidism or hypothyroidism, defined as thyroid-stimulating hormone below the lower limit of normal or greater than 1.5 times the upper limit of normal.
- History of malignant tumor within the previous 5 years.
- Major surgery within the previous 3 months or planned major surgery during the study period.
- Long-term or repeated use of systemic glucocorticoids within the previous 3 months.
Show all 12Show fewer
- Active infectious disease at screening or randomization, psychiatric illness, pregnancy or breastfeeding, or any other condition considered by the investigator to make participation inappropriate.
- Current use of other medications that may significantly affect systemic immune function.
- Acute infection or an active inflammatory condition, such as a respiratory tract infection or recent surgery.
- Hematologic disorders that may affect immune or inflammatory markers, including chronic myeloid leukemia, idiopathic thrombocytopenic purpura, or aplastic anemia.
- Current use of long-acting nitrates or other medications that may affect vasodilatory function.
- Use of other traditional Chinese medicine preparations or dietary supplements with known anti-inflammatory or antioxidant effects, such as curcumin or coenzyme Q10, within 1 month before screening.
Trial locations and contacts
1 site in 1 country.
China1 site
Putuo Hospital, Shanghai University of Traditional Chinese Medicine
Shanghai, Shanghai Municipality, 200062
About this study
Official title: Effect of Huangqi Gegen Decoction on Endothelial Function and Its Mechanisms in Patients With Qi-Yin Deficiency Syndrome and Type 2 Diabetes Mellitus at Very High Risk for Atherosclerotic Cardiovascular Disease
This clinical trial evaluates whether Huangqi Gegen Decoction can improve blood vessel function in adults with type 2 diabetes mellitus who are at very high risk of atherosclerotic cardiovascular disease and meet the traditional Chinese medicine criteria for Qi-Yin deficiency syndrome.
A total of 90 participants are randomly assigned in a 1:1 ratio to receive either Huangqi Gegen Decoction granules or matching placebo granules, in addition to their usual guideline-based treatment, for 12 weeks. Participants and investigators are blinded to treatment assignment.
Read more
The main outcome is flow-mediated dilation (FMD), a noninvasive measure of how well blood vessels dilate. The study also evaluates blood glucose control, blood markers related to endothelial function and inflammation, traditional Chinese medicine syndrome scores, and safety.
The investigators hypothesize that Huangqi Gegen Decoction, when added to conventional treatment, will improve endothelial function compared with placebo.
Read the detailed description
This is a single-center, randomized, double-blind, placebo-controlled clinical trial conducted at Putuo Hospital, Shanghai University of Traditional Chinese Medicine.
Eligible participants are adults aged 18 to 75 years with type 2 diabetes mellitus, very high risk of atherosclerotic cardiovascular disease, and Qi-Yin deficiency syndrome according to traditional Chinese medicine criteria. Participants are randomly assigned in a 1:1 ratio to the experimental group or the placebo control group.
Both groups continue stable conventional treatment for diabetes and cardiovascular risk management. The experimental group receives Huangqi Gegen Decoction granules in addition to conventional treatment, while the control group receives matching placebo granules in addition to conventional treatment. The intervention period is 12 weeks. The study medication and placebo are designed to have similar appearance, packaging, and administration, and participants and investigators remain blinded to treatment assignment.
Participants are assessed at baseline and followed during the 12-week treatment period. Flow-mediated dilation is assessed as the primary measure of endothelial function. Additional assessments include glucose metabolism, biomarkers related to endothelial function and inflammation, traditional Chinese medicine syndrome scores, and safety outcomes. Adverse events and concomitant medications are monitored throughout the study.
The study is designed to determine whether adding Huangqi Gegen Decoction to conventional treatment provides additional improvement in endothelial function and related clinical measures compared with conventional treatment plus placebo.
- Being tested
- Huangqi Gegen Decoction Granules, Placebo Granules, Conventional Treatment
- Keywords
- Huangqi Gegen Decoction, Qi-Yin Deficiency Syndrome, Flow-Mediated Dilation, Endothelial Function, Traditional Chinese Medicine, Atherosclerotic Cardiovascular Disease, ASCVD
- Medical subject headings
- Diabetes Mellitus, Type 2, Atherosclerosis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Huangqi Gegen Decoction GranulesDrug
Huangqi Gegen Decoction granules consist of Huangqi 30 g and Gegen 15 g per daily prescription. Participants receive 2 bags per administration, twice daily, for 12 weeks, in addition to stable conventional treatment. The granules are manufactured by Jiangyin Tianjiang Pharmaceutical Co., Ltd.
Placebo GranulesDrug
Matching placebo granules mainly consist of maltodextrin. Participants receive 2 bags per administration, twice daily, for 12 weeks, in addition to stable conventional treatment. The placebo is matched to Huangqi Gegen Decoction granules in appearance, packaging, dosage, and administration.
Conventional TreatmentOther
Participants continue their stable pre-study conventional treatment regimen for diabetes and cardiovascular risk management throughout the 12-week study. Treatment is continued according to the participant's pre-study regimen and relevant Chinese clinical guidelines, with clinically necessary adjustments permitted for safety.
| Study group | Role | What they receive |
|---|---|---|
| Huangqi Gegen Decoction Group | Experimental | Participants receive Huangqi Gegen Decoction granules in addition to stable conventional treatment for 12 weeks. Conventional treatment is continued according to the participant's pre-study treatment regimen and relevant clinical guidelines. Receives: Drug: Huangqi Gegen Decoction Granules; Other: Conventional Treatment |
| Placebo Comparator Group | Placebo comparator | Participants receive matching placebo granules in addition to stable conventional treatment for 12 weeks. The placebo mainly contains maltodextrin and is matched to Huangqi Gegen Decoction granules in appearance, packaging, and administration. Receives: Drug: Placebo Granules; Other: Conventional Treatment |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change From Baseline in Flow-Mediated Dilation (FMD)
Flow-mediated dilation (FMD) is assessed at baseline and after 12 weeks of treatment using the standardized FMD assessment procedure specified in the study protocol. The change from baseline to Week 12 will be compared between the two treatment groups. Higher FMD values indicate better endothelial-dependent vasodilatory function.
Measured: Baseline and Week 12
Secondary outcomes (11)
Change From Baseline in Fasting Plasma Glucose (FPG)
Fasting plasma glucose is measured at baseline and Week 12. The change from baseline to Week 12 will be compared between the two treatment groups.
Measured: Baseline and Week 12
Change From Baseline in 2-Hour Postprandial Blood Glucose
Two-hour postprandial blood glucose is measured at baseline and Week 12. The change from baseline to Week 12 will be compared between the two treatment groups.
Measured: Baseline and Week 12
Change From Baseline in Glycated Hemoglobin (HbA1c)
Glycated hemoglobin (HbA1c) is measured at baseline and Week 12. The change from baseline to Week 12 will be compared between the two treatment groups.
Measured: Baseline and Week 12
Change From Baseline in von Willebrand Factor (vWF)
Von Willebrand factor (vWF), a biomarker related to endothelial function, is measured at baseline and Week 12 using the prespecified laboratory method. The change from baseline will be compared between groups.
Measured: Baseline and Week 12
Change From Baseline in Endothelial Nitric Oxide Synthase (eNOS)
Endothelial nitric oxide synthase (eNOS) is assessed at baseline and Week 12 as a marker related to endothelial function. The change from baseline will be compared between the two treatment groups.
Measured: Baseline and Week 12
Change From Baseline in Endothelin-1 (ET-1)
Endothelin-1 (ET-1), a biomarker associated with vascular endothelial function, is measured at baseline and Week 12. The change from baseline will be compared between groups.
Measured: Baseline and Week 12
Change From Baseline in Thromboxane B2 (TXB2)
Thromboxane B2 (TXB2) is measured at baseline and Week 12 using the prespecified laboratory method. The change from baseline will be compared between the two treatment groups.
Measured: Baseline and Week 12
Change From Baseline in Soluble Vascular Cell Adhesion Molecule-1 (sVCAM-1)
Soluble vascular cell adhesion molecule-1 (sVCAM-1), a biomarker related to endothelial activation and inflammation, is measured at baseline and Week 12. The change from baseline will be compared between groups.
Measured: Baseline and Week 12
Change From Baseline in Interleukin-18 (IL-18)
Interleukin-18 (IL-18) is measured at baseline and Week 12 as an inflammation-related biomarker. The change from baseline will be compared between the two treatment groups.
Measured: Baseline and Week 12
Change From Baseline in Traditional Chinese Medicine Syndrome Score
The traditional Chinese medicine syndrome score is assessed according to the prespecified criteria for Qi-Yin deficiency syndrome, including primary symptoms, secondary symptoms, tongue characteristics, and pulse characteristics. The change from baseline to Week 12 will be evaluated.
Measured: Baseline and Week 12
Number of Participants With Adverse Events
The number of participants experiencing at least one adverse event during the 12-week treatment period will be recorded. Adverse events are documented regardless of their relationship to the study intervention.
Measured: From the start of treatment through Week 12
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted20 Aug 2026
- Study start4 Aug 2026
- Primary completion30 Oct 2026 (estimated)
- Study completion30 Oct 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Type 2 Diabetes MellitusStudies 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
- Model description
- Participants are randomized in a 1:1 ratio to two parallel groups receiving Huangqi Gegen Decoction granules or matching placebo granules in addition to conventional treatment for 12 weeks.
- Masking
- Double blind
- Who is masked
- Participant, Investigator
- Enrolment
- 90 participants (actual)
Sponsor and investigators
- Lead sponsor
- Putuo Hospital, Shanghai University of Traditional Chinese Medicine
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Chao Liu, Putuo Hospital, Shanghai University of Traditional Chinese Medicine
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07775664
- Sponsor's protocol ID
- HQGGT-ASCVD-2026-01
- Status last verified
- Aug 2026
- First submitted
- 16 Aug 2026
- Last updated
- 20 Aug 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: Individual participant data will not be shared with other researchers. Study data will be used for the purposes of this study and managed in accordance with the approved study protocol and applicable privacy and ethical requirements.
Study at a glance
From the registry record, last updated by the sponsor on 20 Aug 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effect of Huangqi Gegen Decoction on Endothelial Function and Its Mechanisms in Patients With Qi-Yin Deficiency Syndrome and Type 2 Diabetes Mellitus at Very High Risk for Atherosclerotic Cardiovascular Disease
- ClinicalTrials.gov ID
- NCT07775664
- Acronym / sponsor ID
- HQGGT-ASCVD-2026-01
- Keywords
- Huangqi Gegen Decoction, Qi-Yin Deficiency Syndrome, Flow-Mediated Dilation, Endothelial Function, Traditional Chinese Medicine, Atherosclerotic Cardiovascular Disease, ASCVD
- Study type
- Interventional
- Recruitment status
- Active, not recruiting
- Enrolment
- 90 participants (actual)
- Lead sponsor
- Putuo Hospital, Shanghai University of Traditional Chinese MedicineUniversity, hospital or other
- Study start
- 4 Aug 2026 (actual)
- Primary completion
- 30 Oct 2026 (estimated)
- Study completion
- 30 Oct 2026 (estimated)
- First posted
- 20 Aug 2026 (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.
This clinical trial evaluates whether Huangqi Gegen Decoction can improve blood vessel function in adults with type 2 diabetes mellitus who are at very high risk of atherosclerotic cardiovascular disease and meet the traditional Chinese medicine criteria for Qi-Yin deficiency syndrome.
A total of 90 participants are randomly assigned in a 1:1 ratio to receive either Huangqi Gegen Decoction granules or matching placebo granules, in addition to their usual guideline-based treatment, for 12 weeks. Participants and investigators are blinded to treatment assignment.
The main outcome is flow-mediated dilation (FMD), a noninvasive measure of how well blood vessels dilate. The study also evaluates blood glucose control, blood markers related to endothelial function and inflammation, traditional Chinese medicine syndrome scores, and safety.
The investigators hypothesize that Huangqi Gegen Decoction, when added to conventional treatment, will improve endothelial function compared with placebo.
Detailed description
This is a single-center, randomized, double-blind, placebo-controlled clinical trial conducted at Putuo Hospital, Shanghai University of Traditional Chinese Medicine.
Eligible participants are adults aged 18 to 75 years with type 2 diabetes mellitus, very high risk of atherosclerotic cardiovascular disease, and Qi-Yin deficiency syndrome according to traditional Chinese medicine criteria. Participants are randomly assigned in a 1:1 ratio to the experimental group or the placebo control group.
Both groups continue stable conventional treatment for diabetes and cardiovascular risk management. The experimental group receives Huangqi Gegen Decoction granules in addition to conventional treatment, while the control group receives matching placebo granules in addition to conventional treatment. The intervention period is 12 weeks. The study medication and placebo are designed to have similar appearance, packaging, and administration, and participants and investigators remain blinded to treatment assignment.
Participants are assessed at baseline and followed during the 12-week treatment period. Flow-mediated dilation is assessed as the primary measure of endothelial function. Additional assessments include glucose metabolism, biomarkers related to endothelial function and inflammation, traditional Chinese medicine syndrome scores, and safety outcomes. Adverse events and concomitant medications are monitored throughout the study.
The study is designed to determine whether adding Huangqi Gegen Decoction to conventional treatment provides additional improvement in endothelial function and related clinical measures compared with conventional treatment plus placebo.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, investigator)
- Number of arms
- 2
- Model description
- Participants are randomized in a 1:1 ratio to two parallel groups receiving Huangqi Gegen Decoction granules or matching placebo granules in addition to conventional treatment for 12 weeks.
| Arm | Type | Receives |
|---|---|---|
| Huangqi Gegen Decoction Group | Experimental | Drug: Huangqi Gegen Decoction Granules, Other: Conventional TreatmentParticipants receive Huangqi Gegen Decoction granules in addition to stable conventional treatment for 12 weeks. Conventional treatment is continued according to the participant's pre-study treatment regimen and relevant clinical guidelines. |
| Placebo Comparator Group | Placebo comparator | Drug: Placebo Granules, Other: Conventional TreatmentParticipants receive matching placebo granules in addition to stable conventional treatment for 12 weeks. The placebo mainly contains maltodextrin and is matched to Huangqi Gegen Decoction granules in appearance, packaging, and administration. |
Who may qualify
- Ages
- 18 to 75 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (6 listed)
- Aged 18 to 75 years.
- Diagnosed with type 2 diabetes mellitus, with fasting plasma glucose <9.0 mmol/L and glycated hemoglobin (HbA1c) <8.5%, and receiving a stable glucose-lowering treatment regimen without adjustment during the previous 3 months.
- Type 2 diabetes mellitus with target-organ damage or at least 3 additional cardiovascular risk factors.
- Meets the diagnostic criteria for Qi-Yin deficiency syndrome in traditional Chinese medicine, including: (a) primary symptoms of dry mouth and thirst, palpitations, and shortness of breath; (b) secondary symptoms including spontaneous sweating, fatigue, chest tightness, chest discomfort or pain, heat sensation in the palms and soles, polyuria, or constipation; and (c) dark-red tongue and weak, thready pulse. The diagnosis requires at least 2 primary symptoms together with supporting secondary symptoms and tongue/pulse findings, and must be confirmed by at least 2 traditional Chinese medicine physicians at attending-physician level or above.
- Voluntarily participates in the study and provides written informed consent.
Key exclusion criteria (12 listed)
- Allergy to the traditional Chinese medicines used in the study or a history of multiple drug allergies.
- History of severe arrhythmia, including recurrent or symptomatic ventricular tachycardia or atrial fibrillation with rapid ventricular response, or New York Heart Association (NYHA) functional class III-IV heart failure.
- Abnormal thyroid function, including hyperthyroidism or hypothyroidism, defined as thyroid-stimulating hormone below the lower limit of normal or greater than 1.5 times the upper limit of normal.
- History of malignant tumor within the previous 5 years.
- Major surgery within the previous 3 months or planned major surgery during the study period.
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 |
|---|---|---|
| Huangqi Gegen Decoction GranulesHuangqi Gegen Decoction granules consist of Huangqi 30 g and Gegen 15 g per daily prescription. Participants receive 2 bags per administration, twice daily, for 12 weeks, in addition to stable conventional treatment. The granules are manufactured by Jiangyin Tianjiang Pharmaceutical Co., Ltd. | Drug | Huangqi Gegen Decoction Group |
| Placebo GranulesMatching placebo granules mainly consist of maltodextrin. Participants receive 2 bags per administration, twice daily, for 12 weeks, in addition to stable conventional treatment. The placebo is matched to Huangqi Gegen Decoction granules in appearance, packaging, dosage, and administration. | Drug | Placebo Comparator Group |
| Conventional TreatmentParticipants continue their stable pre-study conventional treatment regimen for diabetes and cardiovascular risk management throughout the 12-week study. Treatment is continued according to the participant's pre-study regimen and relevant Chinese clinical guidelines, with clinically necessary adjustments permitted for safety. | Other | Huangqi Gegen Decoction Group, Placebo Comparator Group |
Primary outcome
Change From Baseline in Flow-Mediated Dilation (FMD)
Time frame: Baseline and Week 12
Flow-mediated dilation (FMD) is assessed at baseline and after 12 weeks of treatment using the standardized FMD assessment procedure specified in the study protocol. The change from baseline to Week 12 will be compared between the two treatment groups. Higher FMD values indicate better endothelial-dependent vasodilatory function.
11 secondary outcomes
Change From Baseline in Fasting Plasma Glucose (FPG)
Time frame: Baseline and Week 12
Change From Baseline in 2-Hour Postprandial Blood Glucose
Time frame: Baseline and Week 12
Change From Baseline in Glycated Hemoglobin (HbA1c)
Time frame: Baseline and Week 12
Change From Baseline in von Willebrand Factor (vWF)
Time frame: Baseline and Week 12
Change From Baseline in Endothelial Nitric Oxide Synthase (eNOS)
Time frame: Baseline and Week 12
Change From Baseline in Endothelin-1 (ET-1)
Time frame: Baseline and Week 12
Change From Baseline in Thromboxane B2 (TXB2)
Time frame: Baseline and Week 12
Change From Baseline in Soluble Vascular Cell Adhesion Molecule-1 (sVCAM-1)
Time frame: Baseline and Week 12
Change From Baseline in Interleukin-18 (IL-18)
Time frame: Baseline and Week 12
Change From Baseline in Traditional Chinese Medicine Syndrome Score
Time frame: Baseline and Week 12
Number of Participants With Adverse Events
Time frame: From the start of treatment through Week 12
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 20 Aug 2026.
- Individual participant dataSharing planned: No. Individual participant data will not be shared with other researchers. Study data will be used for the purposes of this study and managed in accordance with the approved study protocol and applicable privacy and ethical requirements.
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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.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Huangqi Gegen Decoction Granules and Conventional Treatment in people with Type 2 Diabetes Mellitus and Endothelial Dysfunction, run by Putuo Hospital, Shanghai University of Traditional Chinese Medicine 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: under way, not looking for participants, as of the sponsor's last update on 20 Aug 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.
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?
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?
Change From Baseline in Flow-Mediated Dilation (FMD) (time frame: Baseline and Week 12). 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 20 Aug 2026.