Acute Viral Respiratory InfectionPhase 1DPBT-AVRINCT07805447
Botanical Therapy for Acute Viral Respiratory Infections
A Phase 1 study testing PurInf I Botanical Formulation, PurInf II Botanical Formulation and PurInf III Botanical Formulation in people with Acute Viral Respiratory Infection, run by All Natural Medicine Clinic, LLC at 1 site in United States.
Trial summary
This Phase 1 study will evaluate the feasibility and safety of implementing a host pathologic state-directed botanical therapeutic platform in adults with acute viral respiratory infections. Read more about this study
- Who is it for?
- Ages 18 to 80 years
- Conditions the study is for
- Acute Viral Respiratory Infection
- What is being tested?
- PurInf I Botanical Formulation, PurInf II Botanical Formulation and PurInf III Botanical Formulation
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 30 participants
- Where
- 1 siteUnited States
- Study dates
- 1 Jul 2027to 30 Jun 2028
- Phase
- Phase 1
- 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 80 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Adults aged 18-80 years.
- Presence of an acute viral respiratory infection or clinical presentation consistent with an acute viral respiratory infection.
- Onset of acute respiratory symptoms within a predefined period before enrollment.
- Presence of one or more predefined pathological states eligible for treatment according to the DPBT clinical algorithm.
- Able and willing to comply with study treatment, clinical assessments, and viral testing.
- Able to understand the study requirements and provide written informed consent.
Who cannot join
- Severe or life-threatening illness requiring immediate hospitalization or emergency medical treatment at enrollment.
- Known allergy, hypersensitivity, or clinically significant intolerance to any ingredient in the botanical formulations that may be administered.
- Pregnancy or breastfeeding.
- Significant medical condition that, in the investigator's judgment, would make participation unsafe or interfere with interpretation of study outcomes.
- Current participation in another interventional clinical trial that could interfere with this study.
- Unable or unwilling to comply with study procedures or provide informed consent.
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
United States1 site
All Natural Medicine Clinic, LLC
Rockville, Maryland, 20852
About this study
Official title: Development and Evaluation of a Host Pathologic State-Directed Botanical Therapeutic Platform Technology for Acute Viral Respiratory Infection
This Phase 1 study will evaluate the feasibility and safety of implementing a host pathologic state-directed botanical therapeutic platform in adults with acute viral respiratory infections. The platform, called Dynamic Pathology-Based Therapy (DPBT), uses a predefined clinical algorithm to identify participants' pathological states and select the corresponding botanical formulation module or combination of modules.
Approximately 30 adults aged 18 to 80 will participate in this prospective, single-group, open-label study. All participants will receive the assigned DPBT intervention in addition to medically appropriate standard care. Treatment will generally continue for 7 days and may be extended through Day 10 if predefined pathological states persist. Study assessments will examine protocol implementation, recruitment and retention, adherence, treatment tolerability, adverse events, changes in symptoms and recovery, and exploratory changes in viral detection through Day 12.
Read the detailed description
This Phase 1 study is a prospective, single-group, open-label feasibility study enrolling approximately 30 adults aged 18 to 80 with acute viral respiratory infections. The study will evaluate the feasibility and safety of implementing a host pathologic state-directed botanical therapeutic platform using a predefined Dynamic Pathology-Based Therapy (DPBT) clinical algorithm.
DPBT is designed to select treatment according to predefined host pathological states rather than solely according to viral identity. Eligible infections may include influenza, respiratory syncytial virus, COVID-19, adenovirus, parainfluenza virus, human metapneumovirus, rhinovirus, or another clinically compatible acute viral respiratory infection. Viral identification testing will be performed when feasible and medically appropriate.
At baseline, participants will undergo eligibility assessment, clinical evaluation, characterization of predefined pathological states, and viral identification testing. Based on each participant's presenting pathological state or combination of states, the corresponding botanical formulation module or combination of modules will be assigned according to the predefined DPBT treatment algorithm. All participants will receive the study intervention in addition to medically appropriate standard care.
Treatment will generally continue for 7 days. Participants will be clinically reassessed during treatment and on Day 7. If predefined pathological states persist, treatment may be extended through Days 8 to 10 according to the protocol. Follow-up viral identification testing will be performed on Day 12 when a respiratory virus was detected at baseline, and repeat testing is feasible.
The primary objectives are to assess the feasibility of implementing the DPBT clinical algorithm and to evaluate safety and tolerability. Feasibility assessments will include recruitment, retention, protocol adherence, completion of required assessments, correct application of the treatment algorithm, and completeness of study data. Safety assessments will include adverse events, serious adverse events, treatment interruptions, discontinuations, and clinical tolerability.
Exploratory assessments will examine changes in respiratory and systemic symptoms, fever, oral intake, activity level, need for additional medical care, return to usual function, and viral detection. Because this is a small, single-group feasibility study, it is not designed or statistically powered to establish definitive efficacy or to compare outcomes among different respiratory viruses.
- Conditions
- Acute Viral Respiratory Infection
- Being tested
- PurInf I Botanical Formulation, PurInf II Botanical Formulation, PurInf III Botanical Formulation, PurCo Botanical Formulation, PurPhl Botanical Formulation
- Keywords
- Dynamic Pathology-Based Therapy, DPBT, Host Pathology-Directed Therapy, Botanical Therapy, Botanical Medicine, Acute Viral Respiratory Infection, Host-Directed Therapy, Respiratory Virus
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
PurInf I Botanical FormulationDrug
A proprietary oral multi-ingredient botanical formulation module assigned through the predefined DPBT clinical algorithm for participants with an upper respiratory inflammatory pathological state. PurInf I may be administered alone or in combination with other DPBT formulation modules according to protocol-defined assessment and reassessment. Treatment will generally continue for 7 days and may be extended through Day 10 if the corresponding pathological state persists. Administration, adherence, treatment modification, interruption, and discontinuation will be documented according to the study protocol.
PurInf II Botanical FormulationDrug
A proprietary oral multi-ingredient botanical formulation module assigned through the predefined DPBT clinical algorithm for participants with a fever-predominant pathological state. PurInf II may be administered alone or in combination with other DPBT formulation modules according to protocol-defined assessment and reassessment. Treatment will generally continue for 7 days and may be extended through Day 10 if the corresponding pathological state persists. Administration, adherence, treatment modification, interruption, and discontinuation will be documented according to the study protocol.
PurInf III Botanical FormulationDrug
A proprietary oral multi-ingredient botanical formulation module assigned through the predefined DPBT clinical algorithm for participants with a lower respiratory inflammatory pathological state. PurInf III may be administered alone or in combination with other DPBT formulation modules according to protocol-defined assessment and reassessment. Treatment will generally continue for 7 days and may be extended through Day 10 if the corresponding pathological state persists. Administration, adherence, treatment modification, interruption, and discontinuation will be documented according to the study protocol.
PurCo Botanical FormulationDrug
A proprietary oral multi-ingredient botanical formulation module assigned through the predefined DPBT clinical algorithm for participants with a cough-predominant pathological state. PurCo may be administered alone or in combination with other DPBT formulation modules according to protocol-defined assessment and reassessment. Treatment will generally continue for 7 days and may be extended through Day 10 if the corresponding pathological state persists. Administration, adherence, treatment modification, interruption, and discontinuation will be documented according to the study protocol.
PurPhl Botanical FormulationDrug
A proprietary oral multi-ingredient botanical formulation module assigned through the predefined DPBT clinical algorithm for participants with a pathological-secretions state. PurPhl may be administered alone or in combination with other DPBT formulation modules according to protocol-defined assessment and reassessment. Treatment will generally continue for 7 days and may be extended through Day 10 if the corresponding pathological state persists. Administration, adherence, treatment modification, interruption, and discontinuation will be documented according to the study protocol.
PurClo Botanical FormulationDrug
A proprietary oral multi-ingredient botanical formulation module assigned through the predefined DPBT clinical algorithm for participants with a clot- and poor-circulation-related pathological state. PurClo may be administered alone or in combination with other DPBT formulation modules according to protocol-defined assessment and reassessment. Treatment will generally continue for 7 days and may be extended through Day 10 if the corresponding pathological state persists. Administration, adherence, treatment modification, interruption, and discontinuation will be documented according to the study protocol.
| Study group | Role | What they receive |
|---|---|---|
| DPBT Botanical Therapy | Experimental | Participants in this single experimental arm will receive host pathologic state-directed botanical therapy using the predefined Dynamic Pathology-Based Therapy (DPBT) clinical algorithm, in addition to medically appropriate standard care. Based on the participant's presenting pathological state or combination of states, the algorithm will assign one or more of six botanical formulation modules: PurInf I for an upper-respiratory inflammatory state, PurInf II for a fever-predominant state, PurInf III for a lower-respiratory inflammatory state, PurCo for a cough-predominant state, PurPhl for a pathological-secretions state, and PurClo for a clot- and poor-circulation-related state. Assigned modules may be continued, added, removed, or discontinued according to protocol-defined reassessment. Treatment will generally continue for 7 days and may be extended through Day 10 if predefined pathological states persist. Receives: Drug: PurInf I Botanical Formulation; Drug: PurInf II Botanical Formulation; Drug: PurInf III Botanical Formulation; Drug: PurCo Botanical Formulation; Drug: PurPhl Botanical Formulation; Drug: PurClo Botanical Formulation |
What is being measured
The primary outcome is the main question the study is designed to answer.
Feasibility of DPBT Protocol Implementation
Proportion of enrolled participants who complete the assigned DPBT treatment and required study assessments according to the protocol.
Measured: Through Day 12
Safety and Tolerability of DPBT Treatment
Number and proportion of participants experiencing adverse events and serious adverse events, including treatment-related adverse events, treatment interruptions, and treatment discontinuations.
Measured: Day 0 through Day 12
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted4 Sep 2026
- Study start1 Jul 2027 (estimated)
- Primary completion30 Jun 2028 (estimated)
- Study completion30 Jun 2028 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Acute Viral Respiratory InfectionStudies 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 1
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Model description
- This is a prospective, single-group, open-label feasibility study. All participants will receive the DPBT intervention in addition to medically appropriate standard care. Within the single study group, a predefined clinical algorithm will identify each participant's host pathological state or combination of states and assign the corresponding botanical formulation module or combination of modules. Treatment may be adjusted according to protocol-defined clinical reassessment. There is no separate control or comparison group
- Masking
- None (open label)
- Enrolment
- 30 participants (estimated)
Sponsor and investigators
- Lead sponsor
- All Natural Medicine Clinic, LLC
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Wanzhu Hou, L.Ac., CH., CMD, MD (CN), Principal investigator, All Natural Medicine Clinic, LLC
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07805447
- Sponsor's protocol ID
- ANMC-DPBT-AVRI-001
- Acronym
- DPBT-AVRI
- Status last verified
- Sep 2026
- First submitted
- 1 Sep 2026
- Last updated
- 4 Sep 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
- Individual data sharing
- Yes: De-identified individual participant data underlying the reported study results may be shared with qualified researchers following publication of the primary study results, consistent with participant informed consent, applicable privacy protections, IRB requirements, and NIH data-sharing policies. Shared data will not contain information that directly identifies individual participants.
Study at a glance
From the registry record, last updated by the sponsor on 4 Sep 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Development and Evaluation of a Host Pathologic State-Directed Botanical Therapeutic Platform Technology for Acute Viral Respiratory Infection
- ClinicalTrials.gov ID
- NCT07805447
- Acronym / sponsor ID
- DPBT-AVRI / ANMC-DPBT-AVRI-001
- Conditions
- Acute Viral Respiratory Infection
- Keywords
- Dynamic Pathology-Based Therapy, DPBT, Host Pathology-Directed Therapy, Botanical Therapy, Botanical Medicine, Acute Viral Respiratory Infection, Host-Directed Therapy, Respiratory Virus
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Not yet recruiting
- Enrolment
- 30 participants (estimated)
- Lead sponsor
- All Natural Medicine Clinic, LLCUniversity, hospital or other
- Study start
- 1 Jul 2027 (estimated)
- Primary completion
- 30 Jun 2028 (estimated)
- Study completion
- 30 Jun 2028 (estimated)
- First posted
- 4 Sep 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 Phase 1 study will evaluate the feasibility and safety of implementing a host pathologic state-directed botanical therapeutic platform in adults with acute viral respiratory infections. The platform, called Dynamic Pathology-Based Therapy (DPBT), uses a predefined clinical algorithm to identify participants' pathological states and select the corresponding botanical formulation module or combination of modules.
Approximately 30 adults aged 18 to 80 will participate in this prospective, single-group, open-label study. All participants will receive the assigned DPBT intervention in addition to medically appropriate standard care. Treatment will generally continue for 7 days and may be extended through Day 10 if predefined pathological states persist. Study assessments will examine protocol implementation, recruitment and retention, adherence, treatment tolerability, adverse events, changes in symptoms and recovery, and exploratory changes in viral detection through Day 12.
Detailed description
This Phase 1 study is a prospective, single-group, open-label feasibility study enrolling approximately 30 adults aged 18 to 80 with acute viral respiratory infections. The study will evaluate the feasibility and safety of implementing a host pathologic state-directed botanical therapeutic platform using a predefined Dynamic Pathology-Based Therapy (DPBT) clinical algorithm.
DPBT is designed to select treatment according to predefined host pathological states rather than solely according to viral identity. Eligible infections may include influenza, respiratory syncytial virus, COVID-19, adenovirus, parainfluenza virus, human metapneumovirus, rhinovirus, or another clinically compatible acute viral respiratory infection. Viral identification testing will be performed when feasible and medically appropriate.
At baseline, participants will undergo eligibility assessment, clinical evaluation, characterization of predefined pathological states, and viral identification testing. Based on each participant's presenting pathological state or combination of states, the corresponding botanical formulation module or combination of modules will be assigned according to the predefined DPBT treatment algorithm. All participants will receive the study intervention in addition to medically appropriate standard care.
Treatment will generally continue for 7 days. Participants will be clinically reassessed during treatment and on Day 7. If predefined pathological states persist, treatment may be extended through Days 8 to 10 according to the protocol. Follow-up viral identification testing will be performed on Day 12 when a respiratory virus was detected at baseline, and repeat testing is feasible.
The primary objectives are to assess the feasibility of implementing the DPBT clinical algorithm and to evaluate safety and tolerability. Feasibility assessments will include recruitment, retention, protocol adherence, completion of required assessments, correct application of the treatment algorithm, and completeness of study data. Safety assessments will include adverse events, serious adverse events, treatment interruptions, discontinuations, and clinical tolerability.
Exploratory assessments will examine changes in respiratory and systemic symptoms, fever, oral intake, activity level, need for additional medical care, return to usual function, and viral detection. Because this is a small, single-group feasibility study, it is not designed or statistically powered to establish definitive efficacy or to compare outcomes among different respiratory viruses.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
- Model description
- This is a prospective, single-group, open-label feasibility study. All participants will receive the DPBT intervention in addition to medically appropriate standard care. Within the single study group, a predefined clinical algorithm will identify each participant's host pathological state or combination of states and assign the corresponding botanical formulation module or combination of modules. Treatment may be adjusted according to protocol-defined clinical reassessment. There is no separate control or comparison group
| Arm | Type | Receives |
|---|---|---|
| DPBT Botanical Therapy | Experimental | Drug: PurInf I Botanical Formulation, Drug: PurInf II Botanical Formulation, Drug: PurInf III Botanical Formulation, Drug: PurCo Botanical Formulation, Drug: PurPhl Botanical Formulation, Drug: PurClo Botanical FormulationParticipants in this single experimental arm will receive host pathologic state-directed botanical therapy using the predefined Dynamic Pathology-Based Therapy (DPBT) clinical algorithm, in addition to medically appropriate standard care. Based on the participant's presenting pathological state or combination of states, the algorithm will assign one or more of six botanical formulation modules: PurInf I for an upper-respiratory inflammatory state, PurInf II for a fever-predominant state, PurInf III for a lower-respiratory inflammatory state, PurCo for a cough-predominant state, PurPhl for a pathological-secretions state, and PurClo for a clot- and poor-circulation-related state. Assigned modules may be continued, added, removed, or discontinued according to protocol-defined reassessment. Treatment will generally continue for 7 days and may be extended through Day 10 if predefined pathological states persist. |
Who may qualify
- Ages
- 18 to 80 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (6 listed)
- Adults aged 18-80 years.
- Presence of an acute viral respiratory infection or clinical presentation consistent with an acute viral respiratory infection.
- Onset of acute respiratory symptoms within a predefined period before enrollment.
- Presence of one or more predefined pathological states eligible for treatment according to the DPBT clinical algorithm.
- Able and willing to comply with study treatment, clinical assessments, and viral testing.
Key exclusion criteria (6 listed)
- Severe or life-threatening illness requiring immediate hospitalization or emergency medical treatment at enrollment.
- Known allergy, hypersensitivity, or clinically significant intolerance to any ingredient in the botanical formulations that may be administered.
- Pregnancy or breastfeeding.
- Significant medical condition that, in the investigator's judgment, would make participation unsafe or interfere with interpretation of study outcomes.
- Current participation in another interventional clinical trial that could interfere with this study.
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 |
|---|---|---|
| PurInf I Botanical FormulationA proprietary oral multi-ingredient botanical formulation module assigned through the predefined DPBT clinical algorithm for participants with an upper respiratory inflammatory pathological state. PurInf I may be administered alone or in combination with other DPBT formulation modules according to protocol-defined assessment and reassessment. Treatment will generally continue for 7 days and may be extended through Day 10 if the corresponding pathological state persists. Administration, adherence, treatment modification, interruption, and discontinuation will be documented according to the study protocol. | Drug | DPBT Botanical Therapy |
| PurInf II Botanical FormulationA proprietary oral multi-ingredient botanical formulation module assigned through the predefined DPBT clinical algorithm for participants with a fever-predominant pathological state. PurInf II may be administered alone or in combination with other DPBT formulation modules according to protocol-defined assessment and reassessment. Treatment will generally continue for 7 days and may be extended through Day 10 if the corresponding pathological state persists. Administration, adherence, treatment modification, interruption, and discontinuation will be documented according to the study protocol. | Drug | DPBT Botanical Therapy |
| PurInf III Botanical FormulationA proprietary oral multi-ingredient botanical formulation module assigned through the predefined DPBT clinical algorithm for participants with a lower respiratory inflammatory pathological state. PurInf III may be administered alone or in combination with other DPBT formulation modules according to protocol-defined assessment and reassessment. Treatment will generally continue for 7 days and may be extended through Day 10 if the corresponding pathological state persists. Administration, adherence, treatment modification, interruption, and discontinuation will be documented according to the study protocol. | Drug | DPBT Botanical Therapy |
| PurCo Botanical FormulationA proprietary oral multi-ingredient botanical formulation module assigned through the predefined DPBT clinical algorithm for participants with a cough-predominant pathological state. PurCo may be administered alone or in combination with other DPBT formulation modules according to protocol-defined assessment and reassessment. Treatment will generally continue for 7 days and may be extended through Day 10 if the corresponding pathological state persists. Administration, adherence, treatment modification, interruption, and discontinuation will be documented according to the study protocol. | Drug | DPBT Botanical Therapy |
| PurPhl Botanical FormulationA proprietary oral multi-ingredient botanical formulation module assigned through the predefined DPBT clinical algorithm for participants with a pathological-secretions state. PurPhl may be administered alone or in combination with other DPBT formulation modules according to protocol-defined assessment and reassessment. Treatment will generally continue for 7 days and may be extended through Day 10 if the corresponding pathological state persists. Administration, adherence, treatment modification, interruption, and discontinuation will be documented according to the study protocol. | Drug | DPBT Botanical Therapy |
| PurClo Botanical FormulationA proprietary oral multi-ingredient botanical formulation module assigned through the predefined DPBT clinical algorithm for participants with a clot- and poor-circulation-related pathological state. PurClo may be administered alone or in combination with other DPBT formulation modules according to protocol-defined assessment and reassessment. Treatment will generally continue for 7 days and may be extended through Day 10 if the corresponding pathological state persists. Administration, adherence, treatment modification, interruption, and discontinuation will be documented according to the study protocol. | Drug | DPBT Botanical Therapy |
Primary outcome
Feasibility of DPBT Protocol Implementation
Time frame: Through Day 12
Proportion of enrolled participants who complete the assigned DPBT treatment and required study assessments according to the protocol.
Safety and Tolerability of DPBT Treatment
Time frame: Day 0 through Day 12
Number and proportion of participants experiencing adverse events and serious adverse events, including treatment-related adverse events, treatment interruptions, and treatment discontinuations.
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 4 Sep 2026.
- Individual participant dataSharing planned: Yes. De-identified individual participant data underlying the reported study results may be shared with qualified researchers following publication of the primary study results, consistent with participant informed consent, applicable privacy protections, IRB requirements, and NIH data-sharing policies. Shared data will not contain information that directly identifies individual participants.
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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.
Wanzhu Hou, L.Ac., CH., CMD, MD (CN) principal investigator
All Natural Medicine Clinic, LLC
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1 study testing PurInf I Botanical Formulation, PurInf II Botanical Formulation and PurInf III Botanical Formulation in people with Acute Viral Respiratory Infection, run by All Natural Medicine Clinic, LLC at 1 site in United States.
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 6 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: opening soon, as of the sponsor's last update on 4 Sep 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 United States. 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.
What does this phase mean?
Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.
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 Wanzhu Hou, l.Ac., CH, CMD, MD(CN) (1(301)770-4480, TCM@anmedicine.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Feasibility of DPBT Protocol Implementation (time frame: Through Day 12). The study lists 2 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 4 Sep 2026.