OsteoarthritisNCT04033757
A Population-based Cohort of Osteoarthritis: the Xiangya Osteoarthritis Study
An observational study of Osteoarthritis, run by Xiangya Hospital of Central South University at 1 site in China.
Trial summary
The purpose of this study is to examine the natural history, phenotypes and risk factors of osteoarthritis (OA) and pain at different joints, and to examine the association between OA structure changes, inflammation and pain for knee and hand OA. Read more about this study
- Who is it for?
- Ages 50 years and olderHealthy volunteers can take part
- Conditions the study is for
- Osteoarthritis
- How many people
- 4,080 participants
- Where
- 1 siteChina
- Study dates
- 17 Nov 2015to Dec 2031
- How long will I take part?
- 12 Years
- Phase
- Observational
- 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 years and older
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Study population: Subjects included in this study were a randomly selected sample of residents, aged 50 years or older, from rural mountainous communities of Longshan County, Hunan Province, China.
Who may be able to join
- 50 years old or above
- Residents of the randomly selected communities
Who cannot join
- Inability to give informed consent
- Terminal or mental illness
- Pregnant women
Trial locations and contacts
1 site in 1 country.
China1 site
Xiangya Hospital of Central South University
Changsha, Hunan, 410008
About this study
The purpose of this study is to examine the natural history, phenotypes and risk factors of osteoarthritis (OA) and pain at different joints, and to examine the association between OA structure changes, inflammation and pain for knee and hand OA.
Read the detailed description
Objectives:
- To understand the natural history of osteoarthritis (OA) at different joints (knee, hip, hand, foot and lumbar).
- To identify different phenotypes of OA (e.g., generalized OA, rapidly progressive knee and hand OA, tibiofemoral OA and patellofemoral OA), their association with pain (e.g., peripheral pain, central pain, nociceptive pain and neuropathic pain) and consequences.
- To examine risk factors of OA (lifestyle habits, nutritional, metabolic, anatomical and genetic factors, etc.) at each joint as well as multiple joints.
- To determine the association between x-ray structure change, ultrasound synovial changes and pain and other symptoms of OA at knee and hand joints within the large-sample community-based population.
- To predict the progression of knee and hand OA within new-onset early-stage knee and hand OA patients, and to identify the rapidly progressive knee and hand OA phenotypes and their related risk factors.
- To investigate the association between gut microbiota and OA.
- To investigate the association between oral microbiota and OA.
Design: This is a prospective community-based cohort study.
Participants: Subjects included in this study were a randomly selected sample of residents, aged 50 years or older from rural mountainous communities of Longshan County, Hunan Province, China. 4000 people were planned to be recruited, divided into three sub-cohorts. 1,469 participants were enrolled in sub-cohort 1 in 2015, and two follow-ups have been completed in 2016 and 2017. 1,267 participants were enrolled in sub-cohort 2 in 2018. 1,340 participants were enrolled in sub-cohort 3 in 2019. Each sub-cohort will be followed every three years regularly.
- Conditions
- Osteoarthritis
- Keywords
- osteoarthritis, cohort study, population-based
- Medical subject headings
- Osteoarthritis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| Sub-cohort 1 | 1,469 participants were enrolled in 2015. Three follow-ups have been completed in 2016, 2017, and 2020. They will be asked to participate in follow-up in 2023 and 2026. | |
| Sub-cohort 2 | 1,267 participants were enrolled in 2018. They will be asked to participate in follow-up in 2021, 2024, 2027, and 2030. | |
| Sub-cohort 3 | 1,340 participants were enrolled in 2019. They will be asked to participate in follow-up in 2022, 2025, 2028, and 2031. |
What is being measured
The primary outcome is the main question the study is designed to answer.
Prevalence of multiple joints osteoarthritis.
Measured by radiographs of multiple joints.
Measured: At enrollment.
Incidence of multiple joints osteoarthritis.
Measured by radiographs of multiple joints, and the incidence of osteoarthritis can be calculated at each follow-up time point.
Measured: At 3, 6, 9, 12 years follow-ups after enrollment.
Progression of multiple joints osteoarthritis.
The changes of joint space and osteophytes are measured by radiographs of multiple joints, to assess the progression of multiple joints osteoarthritis.
Measured: At 3, 6, 9, 12 years follow-ups after enrollment.
Secondary outcomes (31)
Ultrasound detected changes of knee, thigh muscle, and hand.
Ultrasound examination of both knee joints, quadriceps, hamstrings muscle and 15 peripheral joints of wrist and hand.
Measured: At enrollment, and 3, 6, 9, 12 years follow-ups after enrollment.
Changes of pain intensity of knee, hip, hand and lumbar.
Measured by visual analog scale (VAS).
Measured: At enrollment, and 3, 6, 9, 12 years follow-ups after enrollment.
Changes of pain experience of knee.
Measured by intermittent and constant osteoarthritis pain (ICOAP) questionnaire.
Measured: At enrollment, and 3, 6, 9, 12 years follow-ups after enrollment.
Changes of neuropathic pain of knee.
Measured by painDETECT questionnaire (PDQ).
Measured: At enrollment, and 3, 6, 9, 12 years follow-ups after enrollment.
Changes of patient's belief about knee pain.
Measured by illness perception questionnaire (IPQ).
Measured: At enrollment, and 3, 6, 9, 12 years follow-ups after enrollment.
Changes of pain catastrophizing of knee.
Measured by pain catastrophizing scale (PCS).
Measured: At enrollment, and 3, 6, 9, 12 years follow-ups after enrollment.
Prevalence of knee/hip/patellofemoral joint pain.
Measured by a question that "In the past 12 months, have you had knee/hip/patellofemoral joint pain lasting most days of at least a month?"
Measured: At enrollment.
Incidence of knee/hip/patellofemoral joint pain.
Measured by a question that "In the past 12 months, have you had knee/hip/patellofemoral joint pain lasting most days of at least a month?", and the incidence of knee/hip/patellofemoral joint pain can be calculated at each follow-up time point.
Measured: At 3, 6, 9, 12 years follow-ups after enrollment.
Changes of global assessment of knee and hip.
Measured by the Western Ontario and McMaster Universities (WOMAC) score.
Measured: At enrollment, and 3, 6, 9, 12 years follow-ups after enrollment.
Changes of global hand function.
Measured by the Functional Index for Hand Osteoarthritis (FIHOA).
Measured: At enrollment, and 3, 6, 9, 12 years follow-ups after enrollment.
Changes of pain-related disability of lumbar osteoarthritis.
Measured by the Roland-Morris Disability Questionnaire (RMDQ).
Measured: At enrollment, and 3, 6, 9, 12 years follow-ups after enrollment.
Changes of the results of 30s repetition chair stand test.
To test the ability to rise from a chair. Record the times a participant stand up and sit down from a chair within 30 seconds.
Measured: At enrollment, and 3, 6, 9, 12 years follow-ups after enrollment.
Changes of the results of 20-meter walk test.
Record the time a participant spent on walking for 20 meters.
Measured: At enrollment, and 3, 6, 9, 12 years follow-ups after enrollment.
Changes of the results of timed up and go test.
Record the time a participant to rise from a standard armchair, walk as quickly but as safely as possible distance of 3 meters, turn, walk back to the chair and sit down.
Measured: At enrollment, and 3, 6, 9, 12 years follow-ups after enrollment.
Changes of the results of standing balance test.
Record the score of standing balance using a standard test protocol. Tests of standing balance included full tandem, semi-tandem, and side-by-side stands.
Measured: At enrollment, and 3, 6, 9, 12 years follow-ups after enrollment.
Changes of grip strength.
Measured by a Jamar Hydraulic Hand Dynamometer.
Measured: At enrollment, and 3, 6, 9, 12 years follow-ups after enrollment.
Changes of pinch strength.
Measured by a Jamar Hydraulic Pinch Gauge.
Measured: At enrollment, and 3, 6, 9, 12 years follow-ups after enrollment.
Changes of quadriceps strength.
Measured by a 'Nicholas Manual Muscle Tester' (Lafayette Instruments).
Measured: At enrollment, and 3, 6, 9, 12 years follow-ups after enrollment.
Changes of hamstrings strength.
Measured by a 'Nicholas Manual Muscle Tester' (Lafayette Instruments).
Measured: At enrollment, and 3, 6, 9, 12 years follow-ups after enrollment.
Changes of hip abductor.
Measured by a 'Nicholas Manual Muscle Tester' (Lafayette Instruments).
Measured: At enrollment, and 3, 6, 9, 12 years follow-ups after enrollment.
Changes of the results of squatting ability test.
The squatting ability was evaluated by using a 1-4 scale (1 = full squat, no use of arms; 2 = full squat, arms used for support; 3= full squat, examiner assistance needed; 4 = attempted, unable to attain full squat).
Measured: At enrollment, and 3, 6, 9, 12 years follow-ups after enrollment.
Changes of the results of stair climbing test.
Record the time a participant to ascended and descended a flight of five 14 cm steps stair as quickly as possible.
Measured: At enrollment, and 3, 6, 9, 12 years follow-ups after enrollment.
Changes of the results of quantitative sensory testing.
Measured by a hand-held pressure algometer (Wagner, FDIX25) .
Measured: At enrollment, and 3, 6, 9, 12 years follow-ups after enrollment.
Changes of the results of body composition analysis.
Measured by a InBody 770 Body Composition Analyser.
Measured: At enrollment, and 3, 6, 9, 12 years follow-ups after enrollment.
Prevalence of nodal osteoarthritis.
Nodal osteoarthritis was determined using a validated line diagram and classified as present in those reporting nodes on at least two rays of both hands.
Measured: At enrollment.
Prevalence of widespread pain.
A modified body pain mannequin with two questions on symptom severity and widespread pain index (2011 ACR criteria on fibromyalgia) was included to allow scoring of fibromyalgia as a diagnosis with binary (present/absent) classification using a validated tool.
Measured: At enrollment.
Incidence of widespread pain.
A modified body pain mannequin with two questions on symptom severity and widespread pain index (2011 ACR criteria on fibromyalgia) was included to allow scoring of fibromyalgia as a diagnosis with binary (present/absent) classification using a validated tool. The incidence of knee/hip/patellofemoral joint pain can be calculated at each follow-up time point.
Measured: At 3, 6, 9, 12 years follow-ups after enrollment.
Changes of physical and mental health.
Measured by the 12-Item Short-Form Health Survey (SF-12).
Measured: At enrollment, and 3, 6, 9, 12 years follow-ups after enrollment.
Changes of sleep quality.
Measured by the Medical Outcomes Study (MOS) Sleep Scale.
Measured: At enrollment, and 3, 6, 9, 12 years follow-ups after enrollment.
Prevalence of sarcopenia.
Sarcopenia would be diagnosed according to the Asian Working Group for Sarcopenia 2019 algorithm.
Measured: Every round of surveys since year 2018.
Incidence of sarcopenia.
Sarcopenia would be diagnosed according to the Asian Working Group for Sarcopenia 2019 algorithm. And the incidence of sarcopenia can be calculated at each follow-up time point.
Measured: At 3, 6, 9, 12 years follow-ups after enrollment.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted26 Jul 2019
- Study start17 Nov 2015
- Primary completionDec 2031 (estimated)
- Study completionDec 2031 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (2)Papers the sponsor has linked to this study.
- Other trials for OsteoarthritisStudies of the same condition, open and under way.
- More trials run by Xiangya Hospital of Central South UniversityThe 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
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 4,080 participants (actual)
- Target duration
- 12 Years
Sponsor and investigators
- Lead sponsor
- Xiangya Hospital of Central South University
- Sponsor type
- University, hospital or other
- Collaborators
- University of Nottingham, Harvard University
- Responsible party
- Sponsor
- Investigators
- Guanghua Lei, Doctor, Study chair, Xiangya Hospital of Central South University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04033757
- Sponsor's protocol ID
- 201510506
- Status last verified
- Mar 2022
- First submitted
- 4 Jul 2019
- Last updated
- 11 Apr 2022
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided: This cohort study will collect different types of data. The amount of data is large. The investigators have not decided what specific data sets to be shared yet.
Publications
Li J, Xiao Y, Yang T, Hunter DJ, Zhang W, Doherty M, Zhang Y, Yang Z, Wang Y, Xie D, Li C, Zhao K, Li W, Wen Z, Zeng C, Lei G, Wei J. Oral microbiome dysbiosis and oral-gut microbial network disruption in hand osteoarthritis: data from the Xiangya Osteoarthritis Study. RMD Open. 2026 Jul 21;12(3):e006962. doi: 10.1136/rmdopen-2026-006962.
PubMed 42481422Zhu Y, Li J, Zhang Y, Zhang W, Doherty M, Yang Z, Cui Y, Zeng C, Lei G, Yang T, Wei J. Association between hyperuricaemia and hand osteoarthritis: data from the Xiangya Osteoarthritis Study. RMD Open. 2023 Dec 1;9(4):e003683. doi: 10.1136/rmdopen-2023-003683.
PubMed 38053456
Study at a glance
From the registry record, last updated by the sponsor on 11 Apr 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Population-based Cohort of Osteoarthritis: the Xiangya Osteoarthritis Study
- ClinicalTrials.gov ID
- NCT04033757
- Acronym / sponsor ID
- 201510506
- Conditions
- Osteoarthritis
- Keywords
- osteoarthritis, cohort study, population-based
- Study type
- Observational
- Recruitment status
- Active, not recruiting
- Enrolment
- 4,080 participants (actual)
- Lead sponsor
- Xiangya Hospital of Central South UniversityUniversity, hospital or other
- Collaborators
- University of Nottingham, Harvard University
- Study start
- 17 Nov 2015 (actual)
- Primary completion
- Dec 2031 (estimated)
- Study completion
- Dec 2031 (estimated)
- First posted
- 26 Jul 2019 (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 purpose of this study is to examine the natural history, phenotypes and risk factors of osteoarthritis (OA) and pain at different joints, and to examine the association between OA structure changes, inflammation and pain for knee and hand OA.
Detailed description
Objectives:
- To understand the natural history of osteoarthritis (OA) at different joints (knee, hip, hand, foot and lumbar).
- To identify different phenotypes of OA (e.g., generalized OA, rapidly progressive knee and hand OA, tibiofemoral OA and patellofemoral OA), their association with pain (e.g., peripheral pain, central pain, nociceptive pain and neuropathic pain) and consequences.
- To examine risk factors of OA (lifestyle habits, nutritional, metabolic, anatomical and genetic factors, etc.) at each joint as well as multiple joints.
- To determine the association between x-ray structure change, ultrasound synovial changes and pain and other symptoms of OA at knee and hand joints within the large-sample community-based population.
- To predict the progression of knee and hand OA within new-onset early-stage knee and hand OA patients, and to identify the rapidly progressive knee and hand OA phenotypes and their related risk factors.
- To investigate the association between gut microbiota and OA.
- To investigate the association between oral microbiota and OA.
Design: This is a prospective community-based cohort study.
Participants: Subjects included in this study were a randomly selected sample of residents, aged 50 years or older from rural mountainous communities of Longshan County, Hunan Province, China. 4000 people were planned to be recruited, divided into three sub-cohorts. 1,469 participants were enrolled in sub-cohort 1 in 2015, and two follow-ups have been completed in 2016 and 2017. 1,267 participants were enrolled in sub-cohort 2 in 2018. 1,340 participants were enrolled in sub-cohort 3 in 2019. Each sub-cohort will be followed every three years regularly.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Target follow-up
- 12 Years
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Sub-cohort 1 | – | –1,469 participants were enrolled in 2015. Three follow-ups have been completed in 2016, 2017, and 2020. They will be asked to participate in follow-up in 2023 and 2026. |
| Sub-cohort 2 | – | –1,267 participants were enrolled in 2018. They will be asked to participate in follow-up in 2021, 2024, 2027, and 2030. |
| Sub-cohort 3 | – | –1,340 participants were enrolled in 2019. They will be asked to participate in follow-up in 2022, 2025, 2028, and 2031. |
Who may qualify
- Ages
- 50 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
- Study population
- Subjects included in this study were a randomly selected sample of residents, aged 50 years or older, from rural mountainous communities of Longshan County, Hunan Province, China.
Key inclusion criteria (2 listed)
- 50 years old or above
- Residents of the randomly selected communities
Key exclusion criteria (3 listed)
- Inability to give informed consent
- Terminal or mental illness
- Pregnant women
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Prevalence of multiple joints osteoarthritis.
Time frame: At enrollment.
Measured by radiographs of multiple joints.
Incidence of multiple joints osteoarthritis.
Time frame: At 3, 6, 9, 12 years follow-ups after enrollment.
Measured by radiographs of multiple joints, and the incidence of osteoarthritis can be calculated at each follow-up time point.
Progression of multiple joints osteoarthritis.
Time frame: At 3, 6, 9, 12 years follow-ups after enrollment.
The changes of joint space and osteophytes are measured by radiographs of multiple joints, to assess the progression of multiple joints osteoarthritis.
31 secondary outcomes
Ultrasound detected changes of knee, thigh muscle, and hand.
Time frame: At enrollment, and 3, 6, 9, 12 years follow-ups after enrollment.
Changes of pain intensity of knee, hip, hand and lumbar.
Time frame: At enrollment, and 3, 6, 9, 12 years follow-ups after enrollment.
Changes of pain experience of knee.
Time frame: At enrollment, and 3, 6, 9, 12 years follow-ups after enrollment.
Changes of neuropathic pain of knee.
Time frame: At enrollment, and 3, 6, 9, 12 years follow-ups after enrollment.
Changes of patient's belief about knee pain.
Time frame: At enrollment, and 3, 6, 9, 12 years follow-ups after enrollment.
Changes of pain catastrophizing of knee.
Time frame: At enrollment, and 3, 6, 9, 12 years follow-ups after enrollment.
Prevalence of knee/hip/patellofemoral joint pain.
Time frame: At enrollment.
Incidence of knee/hip/patellofemoral joint pain.
Time frame: At 3, 6, 9, 12 years follow-ups after enrollment.
Changes of global assessment of knee and hip.
Time frame: At enrollment, and 3, 6, 9, 12 years follow-ups after enrollment.
Changes of global hand function.
Time frame: At enrollment, and 3, 6, 9, 12 years follow-ups after enrollment.
Changes of pain-related disability of lumbar osteoarthritis.
Time frame: At enrollment, and 3, 6, 9, 12 years follow-ups after enrollment.
Changes of the results of 30s repetition chair stand test.
Time frame: At enrollment, and 3, 6, 9, 12 years follow-ups after enrollment.
Changes of the results of 20-meter walk test.
Time frame: At enrollment, and 3, 6, 9, 12 years follow-ups after enrollment.
Changes of the results of timed up and go test.
Time frame: At enrollment, and 3, 6, 9, 12 years follow-ups after enrollment.
Changes of the results of standing balance test.
Time frame: At enrollment, and 3, 6, 9, 12 years follow-ups after enrollment.
Changes of grip strength.
Time frame: At enrollment, and 3, 6, 9, 12 years follow-ups after enrollment.
Changes of pinch strength.
Time frame: At enrollment, and 3, 6, 9, 12 years follow-ups after enrollment.
Changes of quadriceps strength.
Time frame: At enrollment, and 3, 6, 9, 12 years follow-ups after enrollment.
Changes of hamstrings strength.
Time frame: At enrollment, and 3, 6, 9, 12 years follow-ups after enrollment.
Changes of hip abductor.
Time frame: At enrollment, and 3, 6, 9, 12 years follow-ups after enrollment.
Changes of the results of squatting ability test.
Time frame: At enrollment, and 3, 6, 9, 12 years follow-ups after enrollment.
Changes of the results of stair climbing test.
Time frame: At enrollment, and 3, 6, 9, 12 years follow-ups after enrollment.
Changes of the results of quantitative sensory testing.
Time frame: At enrollment, and 3, 6, 9, 12 years follow-ups after enrollment.
Changes of the results of body composition analysis.
Time frame: At enrollment, and 3, 6, 9, 12 years follow-ups after enrollment.
Prevalence of nodal osteoarthritis.
Time frame: At enrollment.
Prevalence of widespread pain.
Time frame: At enrollment.
Incidence of widespread pain.
Time frame: At 3, 6, 9, 12 years follow-ups after enrollment.
Changes of physical and mental health.
Time frame: At enrollment, and 3, 6, 9, 12 years follow-ups after enrollment.
Changes of sleep quality.
Time frame: At enrollment, and 3, 6, 9, 12 years follow-ups after enrollment.
Prevalence of sarcopenia.
Time frame: Every round of surveys since year 2018.
Incidence of sarcopenia.
Time frame: At 3, 6, 9, 12 years follow-ups after enrollment.
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 11 Apr 2022.
- Derived from this study: PubMed 42481422Li J, Xiao Y, Yang T, Hunter DJ, Zhang W, Doherty M, Zhang Y, Yang Z, Wang Y, Xie D, Li C, Zhao K, Li W, Wen Z, Zeng C, Lei G, Wei J. Oral microbiome dysbiosis and oral-gut microbial network disruption in hand osteoarthritis: data from the Xiangya Osteoarthritis Study. RMD Open. 2026 Jul 21;12(3):e006962. doi: 10.1136/rmdopen-2026-006962.
- Derived from this study: PubMed 38053456Zhu Y, Li J, Zhang Y, Zhang W, Doherty M, Yang Z, Cui Y, Zeng C, Lei G, Yang T, Wei J. Association between hyperuricaemia and hand osteoarthritis: data from the Xiangya Osteoarthritis Study. RMD Open. 2023 Dec 1;9(4):e003683. doi: 10.1136/rmdopen-2023-003683.
- Individual participant dataSharing planned: Undecided. This cohort study will collect different types of data. The amount of data is large. The investigators have not decided what specific data sets to be shared yet.
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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.
Guanghua Lei, Doctor study chair
Xiangya Hospital of Central South University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Osteoarthritis, run by Xiangya Hospital of Central South University 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 2 inclusion and 3 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 11 Apr 2022. 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. 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?
Prevalence of multiple joints osteoarthritis. (time frame: At enrollment.). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT04033757, which also lists 2 linked publications.
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 11 Apr 2022.