Knee ArthritisNCT05347602
Gold Factor on Knee Joint Health and Function
A study testing Gold Factor (Gold Nanoparticles, AuNPs) in people with Knee Arthritis and Knee Osteoarthritis, run by 4Life Research, LLC at 1 site in United States.
Trial summary
The purpose of this clinical study was to determine whether gold nanoparticles (AuNP) supplement holds clinical value in improving joint health, function, and quality of life for arthritis patients. Read more about this study
- Who is it for?
- Ages 18 to 87 years
- Conditions the study is for
- Knee Arthritis, Knee Osteoarthritis, Knee Pain Chronic
- What is being tested?
- Gold Factor (Gold Nanoparticles, AuNPs)
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 51 participants
- Where
- 1 siteUnited States
- Study dates
- 3 Aug 2020to 30 Dec 2020
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 87 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- ≥ 18 and <87 years of age
- Having arthritis
- Suffering from chronic knee pain
- Failed treatments to date - including surgery, Physical Therapy, NSAIDs
- Must agree to maintain the same eating, exercise, and sleep arrangements for the whole duration of the study
Who cannot join
- Having bacterial, intra-articular, or knee infections
- Had any knee related partial or complete total knee replacement within 3 months prior to the start of the study
- Had recent (3 months prior to start of the study) knee injection
- Currently on NSAIDs
- currently pregnant or lactating
Trial locations and contacts
1 site in 1 country.
United States1 site
Professional Athletic Orthopedics
St Louis, Missouri, 63122
About this study
Official title: A Clinical Study to Evaluate the Safety and Efficacy of Microscopic Doses Oral Administration of Gold Nanoparticles (AuNPs) on Knee Joint Health and Function
The purpose of this clinical study was to determine whether gold nanoparticles (AuNP) supplement holds clinical value in improving joint health, function, and quality of life for arthritis patients.
Read the detailed description
The purpose of this clinical study was to determine whether gold nanoparticles (AuNP) supplement holds clinical value in improving knee joint health, function, and quality of life for arthritis patients. A total of 51 participants were followed for 20 weeks through a three phase longitudinal study. Both subjective and objective parameters were used to measure and monitor changes in knee joint health and function, as well as quality of life.
- Conditions
- Knee Arthritis, Knee Osteoarthritis, Knee Pain Chronic, Knee Discomfort, Rheumatoid Arthritis, Knee Pain Swelling
- Being tested
- Gold Factor (Gold Nanoparticles, AuNPs), Placebo
- Keywords
- Knee joint health, Arthritis, Gold nanoparticles (AuNPs), Knee joint function, Osteoarthritis, Rheumatoid Arthritis
- Medical subject headings
- Osteoarthritis, Knee, Arthritis, Rheumatoid, Arthritis, Osteoarthritis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Gold Factor (Gold Nanoparticles, AuNPs)Dietary supplement
Also called AuNP Supplement
AuNP used in the study is an aqueous suspension of clean-surfaced, faceted gold nanoparticles that have extraordinary catalytic capabilities. AuNP were 8 - 28 nm in diameter, with varying shapes from bipyramids to polyhedrons. To avoid contamination, AuNP was suspended in ultra-pure water, and were not coated with any proteins or molecules to avoid negative reactions within living tissues. This resulted in a rose-pink color due to the incident light inducing a specific resonance known as the localized surface plasmon resonance. The AuNP supplement used in this study contains elemental gold at 6 ppm. Study dosage is 1 oz per day, which is about 0.17 mg elemental gold per day.
PlaceboDietary supplement
For the Placebo, water and red dye were mixed to create a placebo liquid with the same rose-pink shade as the AuNP supplement, along with flavoring that matched the AuNP supplement.
| Study group | Role | What they receive |
|---|---|---|
| Phase 1: double-blinded placebo-controlled Supplement vs Placebo | Other | Phase 1 (8 weeks): Supplement and Placebo groups ingested 3 oz of Supplement and Placebo per day respectively for the first four weeks as a loading dose, and then switched to 2 oz per day for weeks 5 - 8. This phase was double-blinded. Receives: Dietary Supplement: Gold Factor (Gold Nanoparticles, AuNPs); Dietary Supplement: Placebo |
| Washout Phase | No intervention | Phase 2 (4 weeks): Both groups underwent a month-long "wash out" period, during which they did not ingest any of the Supplement or Placebo. This lasted from weeks 9-12. This phase was not double-blinded as all participants and the researchers were aware of the wash-out procedure. |
| Phase 3: Supplement | Active comparator | Phase 3 (8 weeks): Both groups took the Supplement at 3 oz per day as a loading dose for four weeks (weeks 13 - 16), and then 2 oz per day for the final four weeks (weeks 17 - 20). This phase was open labeled, as all participants and the researchers were aware that all participants were ingesting the Supplement. Receives: Dietary Supplement: Gold Factor (Gold Nanoparticles, AuNPs) |
What is being measured
The primary outcome is the main question the study is designed to answer.
Knee injury and Osteoarthritis Outcome Score (KOOS): Pain score
The KOOS survey was chosen due to its repeatability, and it gave scores of 0-100 for four separate categories: Symptoms, Pain, Function \& Daily Living, Sports \& Recreational Activities, and Quality of Life. Under KOOS scoring guidelines, a score of zero represents extreme knee problems, and 100 represents complete function of the knee with no pain, discomfort, or other joint related problems.
Measured: 20 weeks
Knee injury and Osteoarthritis Outcome Score (KOOS): Symptoms score
The KOOS survey was chosen due to its repeatability, and it gave scores of 0-100 for four separate categories: Symptoms, Pain, Function \& Daily Living, Sports \& Recreational Activities, and Quality of Life. Under KOOS scoring guidelines, a score of zero represents extreme knee problems, and 100 represents complete function of the knee with no pain, discomfort, or other joint related problems.
Measured: 20 weeks
Knee injury and Osteoarthritis Outcome Score (KOOS): Function in Activities of Daily Living (ADL) score
The KOOS survey was chosen due to its repeatability, and it gave scores of 0-100 for four separate categories: Symptoms, Pain, Function \& Daily Living, Sports \& Recreational Activities, and Quality of Life. Under KOOS scoring guidelines, a score of zero represents extreme knee problems, and 100 represents complete function of the knee with no pain, discomfort, or other joint related problems.
Measured: 20 weeks
Knee injury and Osteoarthritis Outcome Score (KOOS): Function in Sports and Recreation score
The KOOS survey was chosen due to its repeatability, and it gave scores of 0-100 for four separate categories: Symptoms, Pain, Function \& Daily Living, Sports \& Recreational Activities, and Quality of Life. Under KOOS scoring guidelines, a score of zero represents extreme knee problems, and 100 represents complete function of the knee with no pain, discomfort, or other joint related problems.
Measured: 20 weeks
Knee injury and Osteoarthritis Outcome Score (KOOS): Quality of Life score
The KOOS survey was chosen due to its repeatability, and it gave scores of 0-100 for four separate categories: Symptoms, Pain, Function \& Daily Living, Sports \& Recreational Activities, and Quality of Life. Under KOOS scoring guidelines, a score of zero represents extreme knee problems, and 100 represents complete function of the knee with no pain, discomfort, or other joint related problems.
Measured: 20 weeks
C-Reactive Protein
C-Reactive Protein levels were measured at T0 for baseline scores, and then measured again at T1, T2, and T3. As CRP levels are biomarkers of systemic inflammation, it was expected to see a decrease in CRP levels when taking AuNP Supplement.
Measured: 20 weeks
Range of Motion Bilateral Flexion score
All participants completed a physical assessment conducted by an assigned physical therapist: Range of Motion Bilateral Flexion, Leg Press, Walk Test, Sit-to Stand and Single Leg Squats.
Measured: 20 weeks
Leg Press repetition number
All participants completed a physical assessment conducted by an assigned physical therapist: Range of Motion Bilateral Flexion, Leg Press, Walk Test, Sit-to Stand and Single Leg Squats.
Measured: 20 weeks
6-minute Walk distance (meter)
All participants completed a physical assessment conducted by an assigned physical therapist: Range of Motion Bilateral Flexion, Leg Press, Walk Test, Sit-to Stand and Single Leg Squats.
Measured: 20 weeks
Sit-to Stand repetition number
All participants completed a physical assessment conducted by an assigned physical therapist: Range of Motion Bilateral Flexion, Leg Press, Walk Test, Sit-to Stand and Single Leg Squats.
Measured: 20 weeks
Single Leg Squats repetition number
All participants completed a physical assessment conducted by an assigned physical therapist: Range of Motion Bilateral Flexion, Leg Press, Walk Test, Sit-to Stand and Single Leg Squats.
Measured: 20 weeks
Secondary outcomes (7)
Number of Event for Loss of Balance (LOB)
DorsaVi Assessments: Loss of Balance (LOB), Movement efficiency index, Squat Lumbar Flexion Deviation, Squat Lateral Shift Deviations, single leg squat scores, speed, and tibial inclination
Measured: 20 weeks
Movement efficiency index
DorsaVi Assessments: Loss of Balance (LOB), Movement efficiency index, Squat Lumbar Flexion Deviation, Squat Lateral Shift Deviations, single leg squat scores, speed, and tibial inclination
Measured: 20 weeks
Squat Lumbar Flexion Deviation score
DorsaVi Assessments: Loss of Balance (LOB), Movement efficiency index, Squat Lumbar Flexion Deviation, Squat Lateral Shift Deviations, single leg squat scores, speed, and tibial inclination
Measured: 20 weeks
Squat Lateral Shift Deviation score
DorsaVi Assessments: Loss of Balance (LOB), Movement efficiency index, Squat Lumbar Flexion Deviation, Squat Lateral Shift Deviations, single leg squat scores, speed, and tibial inclination
Measured: 20 weeks
single leg squat speed
DorsaVi Assessments: Loss of Balance (LOB), Movement efficiency index, Squat Lumbar Flexion Deviation, Squat Lateral Shift Deviations, single leg squat scores, speed, and tibial inclination
Measured: 20 weeks
single leg squat tibial inclination
DorsaVi Assessments: Loss of Balance (LOB), Movement efficiency index, Squat Lumbar Flexion Deviation, Squat Lateral Shift Deviations, single leg squat scores, speed, and tibial inclination
Measured: 20 weeks
Percentage of participants that would continue taking the product after the study ended.
Acceptability of AuNP Supplement was analyzed at the end of the study. Participants were asked if they would continue taking the product after the study in their final exit survey.
Measured: 20 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted26 Apr 2022
- Study start3 Aug 2020
- Primary completion30 Dec 2020
- Study completion30 Dec 2020
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Knee ArthritisStudies 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
- Sequential
- Model description
- Fifty-one (51) subjects were determined eligible for the study after the screenings and then were divided into two groups, AuNP Supplement (n=26) and Placebo (n=25). The study was partially double-blinded, and divided into three phases as follows: Phase 1: Supplement and Placebo groups ingested Supplement and Placebo as instructed. This phase was double-blinded. Phase 2: Both groups underwent a month-long "wash out" period, during which they did not ingest any of the Supplement or Placebo. This phase was not double-blinded as all participants and the researchers were aware of the wash-out procedure. Phase 3: Both groups took the Supplement as instructed. This phase was open labeled, as all participants and the researchers were aware that all participants were ingesting the Supplement.
- Masking
- Double blind
- Who is masked
- Participant, Investigator
- Enrolment
- 51 participants (actual)
Sponsor and investigators
- Lead sponsor
- 4Life Research, LLC
- Sponsor type
- Industry (pharma, biotech, devices)
- Collaborators
- Professional Athletic Orthopedics, St. Louis University
- Responsible party
- Sponsor
- Investigators
- Richard C Lehman, MD, Principal investigator, Professional Athletic Orthopedics
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05347602
- Sponsor's protocol ID
- GF-AuKHC46
- Status last verified
- Jul 2022
- First submitted
- 14 Apr 2022
- Last updated
- 12 Jul 2022
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 12 Jul 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Clinical Study to Evaluate the Safety and Efficacy of Microscopic Doses Oral Administration of Gold Nanoparticles (AuNPs) on Knee Joint Health and Function
- ClinicalTrials.gov ID
- NCT05347602
- Acronym / sponsor ID
- GF-AuKHC46
- Conditions
- Knee Arthritis, Knee Osteoarthritis, Knee Pain Chronic, Knee Discomfort, Rheumatoid Arthritis, Knee Pain Swelling
- Keywords
- Knee joint health, Arthritis, Gold nanoparticles (AuNPs), Knee joint function, Osteoarthritis, Rheumatoid Arthritis
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 51 participants (actual)
- Lead sponsor
- 4Life Research, LLCIndustry (pharma, biotech, devices)
- Collaborators
- Professional Athletic Orthopedics, St. Louis University
- Study start
- 3 Aug 2020 (actual)
- Primary completion
- 30 Dec 2020 (actual)
- Study completion
- 30 Dec 2020 (actual)
- First posted
- 26 Apr 2022 (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 clinical study was to determine whether gold nanoparticles (AuNP) supplement holds clinical value in improving joint health, function, and quality of life for arthritis patients.
Detailed description
The purpose of this clinical study was to determine whether gold nanoparticles (AuNP) supplement holds clinical value in improving knee joint health, function, and quality of life for arthritis patients. A total of 51 participants were followed for 20 weeks through a three phase longitudinal study. Both subjective and objective parameters were used to measure and monitor changes in knee joint health and function, as well as quality of life.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Sequential
- Masking
- Double blind (participant, investigator)
- Number of arms
- 3
- Model description
- Fifty-one (51) subjects were determined eligible for the study after the screenings and then were divided into two groups, AuNP Supplement (n=26) and Placebo (n=25). The study was partially double-blinded, and divided into three phases as follows: Phase 1: Supplement and Placebo groups ingested Supplement and Placebo as instructed. This phase was double-blinded. Phase 2: Both groups underwent a month-long "wash out" period, during which they did not ingest any of the Supplement or Placebo. This phase was not double-blinded as all participants and the researchers were aware of the wash-out procedure. Phase 3: Both groups took the Supplement as instructed. This phase was open labeled, as all participants and the researchers were aware that all participants were ingesting the Supplement.
| Arm | Type | Receives |
|---|---|---|
| Phase 1: double-blinded placebo-controlled Supplement vs Placebo | Other | Dietary Supplement: Gold Factor (Gold Nanoparticles, AuNPs), Dietary Supplement: PlaceboPhase 1 (8 weeks): Supplement and Placebo groups ingested 3 oz of Supplement and Placebo per day respectively for the first four weeks as a loading dose, and then switched to 2 oz per day for weeks 5 - 8. This phase was double-blinded. |
| Washout Phase | No intervention | –Phase 2 (4 weeks): Both groups underwent a month-long "wash out" period, during which they did not ingest any of the Supplement or Placebo. This lasted from weeks 9-12. This phase was not double-blinded as all participants and the researchers were aware of the wash-out procedure. |
| Phase 3: Supplement | Active comparator | Dietary Supplement: Gold Factor (Gold Nanoparticles, AuNPs)Phase 3 (8 weeks): Both groups took the Supplement at 3 oz per day as a loading dose for four weeks (weeks 13 - 16), and then 2 oz per day for the final four weeks (weeks 17 - 20). This phase was open labeled, as all participants and the researchers were aware that all participants were ingesting the Supplement. |
Who may qualify
- Ages
- 18 to 87 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- ≥ 18 and <87 years of age
- Having arthritis
- Suffering from chronic knee pain
- Failed treatments to date - including surgery, Physical Therapy, NSAIDs
- Must agree to maintain the same eating, exercise, and sleep arrangements for the whole duration of the study
Key exclusion criteria (5 listed)
- Having bacterial, intra-articular, or knee infections
- Had any knee related partial or complete total knee replacement within 3 months prior to the start of the study
- Had recent (3 months prior to start of the study) knee injection
- Currently on NSAIDs
- currently pregnant or lactating
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 |
|---|---|---|
| Gold Factor (Gold Nanoparticles, AuNPs)Also: AuNP SupplementAuNP used in the study is an aqueous suspension of clean-surfaced, faceted gold nanoparticles that have extraordinary catalytic capabilities. AuNP were 8 - 28 nm in diameter, with varying shapes from bipyramids to polyhedrons. To avoid contamination, AuNP was suspended in ultra-pure water, and were not coated with any proteins or molecules to avoid negative reactions within living tissues. This resulted in a rose-pink color due to the incident light inducing a specific resonance known as the localized surface plasmon resonance. The AuNP supplement used in this study contains elemental gold at 6 ppm. Study dosage is 1 oz per day, which is about 0.17 mg elemental gold per day. | Dietary supplement | Phase 1: double-blinded placebo-controlled Supplement vs Placebo, Phase 3: Supplement |
| PlaceboFor the Placebo, water and red dye were mixed to create a placebo liquid with the same rose-pink shade as the AuNP supplement, along with flavoring that matched the AuNP supplement. | Dietary supplement | Phase 1: double-blinded placebo-controlled Supplement vs Placebo |
Primary outcome
Knee injury and Osteoarthritis Outcome Score (KOOS): Pain score
Time frame: 20 weeks
The KOOS survey was chosen due to its repeatability, and it gave scores of 0-100 for four separate categories: Symptoms, Pain, Function \& Daily Living, Sports \& Recreational Activities, and Quality of Life. Under KOOS scoring guidelines, a score of zero represents extreme knee problems, and 100 represents complete function of the knee with no pain, discomfort, or other joint related problems.
Knee injury and Osteoarthritis Outcome Score (KOOS): Symptoms score
Time frame: 20 weeks
The KOOS survey was chosen due to its repeatability, and it gave scores of 0-100 for four separate categories: Symptoms, Pain, Function \& Daily Living, Sports \& Recreational Activities, and Quality of Life. Under KOOS scoring guidelines, a score of zero represents extreme knee problems, and 100 represents complete function of the knee with no pain, discomfort, or other joint related problems.
Knee injury and Osteoarthritis Outcome Score (KOOS): Function in Activities of Daily Living (ADL) score
Time frame: 20 weeks
The KOOS survey was chosen due to its repeatability, and it gave scores of 0-100 for four separate categories: Symptoms, Pain, Function \& Daily Living, Sports \& Recreational Activities, and Quality of Life. Under KOOS scoring guidelines, a score of zero represents extreme knee problems, and 100 represents complete function of the knee with no pain, discomfort, or other joint related problems.
Knee injury and Osteoarthritis Outcome Score (KOOS): Function in Sports and Recreation score
Time frame: 20 weeks
The KOOS survey was chosen due to its repeatability, and it gave scores of 0-100 for four separate categories: Symptoms, Pain, Function \& Daily Living, Sports \& Recreational Activities, and Quality of Life. Under KOOS scoring guidelines, a score of zero represents extreme knee problems, and 100 represents complete function of the knee with no pain, discomfort, or other joint related problems.
Knee injury and Osteoarthritis Outcome Score (KOOS): Quality of Life score
Time frame: 20 weeks
The KOOS survey was chosen due to its repeatability, and it gave scores of 0-100 for four separate categories: Symptoms, Pain, Function \& Daily Living, Sports \& Recreational Activities, and Quality of Life. Under KOOS scoring guidelines, a score of zero represents extreme knee problems, and 100 represents complete function of the knee with no pain, discomfort, or other joint related problems.
C-Reactive Protein
Time frame: 20 weeks
C-Reactive Protein levels were measured at T0 for baseline scores, and then measured again at T1, T2, and T3. As CRP levels are biomarkers of systemic inflammation, it was expected to see a decrease in CRP levels when taking AuNP Supplement.
Range of Motion Bilateral Flexion score
Time frame: 20 weeks
All participants completed a physical assessment conducted by an assigned physical therapist: Range of Motion Bilateral Flexion, Leg Press, Walk Test, Sit-to Stand and Single Leg Squats.
Leg Press repetition number
Time frame: 20 weeks
All participants completed a physical assessment conducted by an assigned physical therapist: Range of Motion Bilateral Flexion, Leg Press, Walk Test, Sit-to Stand and Single Leg Squats.
6-minute Walk distance (meter)
Time frame: 20 weeks
All participants completed a physical assessment conducted by an assigned physical therapist: Range of Motion Bilateral Flexion, Leg Press, Walk Test, Sit-to Stand and Single Leg Squats.
Sit-to Stand repetition number
Time frame: 20 weeks
All participants completed a physical assessment conducted by an assigned physical therapist: Range of Motion Bilateral Flexion, Leg Press, Walk Test, Sit-to Stand and Single Leg Squats.
Single Leg Squats repetition number
Time frame: 20 weeks
All participants completed a physical assessment conducted by an assigned physical therapist: Range of Motion Bilateral Flexion, Leg Press, Walk Test, Sit-to Stand and Single Leg Squats.
7 secondary outcomes
Number of Event for Loss of Balance (LOB)
Time frame: 20 weeks
Movement efficiency index
Time frame: 20 weeks
Squat Lumbar Flexion Deviation score
Time frame: 20 weeks
Squat Lateral Shift Deviation score
Time frame: 20 weeks
single leg squat speed
Time frame: 20 weeks
single leg squat tibial inclination
Time frame: 20 weeks
Percentage of participants that would continue taking the product after the study ended.
Time frame: 20 weeks
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 12 Jul 2022.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Richard C Lehman, MD principal investigator
Professional Athletic Orthopedics
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Gold Factor (Gold Nanoparticles, AuNPs) in people with Knee Arthritis and Knee Osteoarthritis, run by 4Life Research, 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 5 inclusion and 5 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 12 Jul 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 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.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Knee injury and Osteoarthritis Outcome Score (KOOS): Pain score (time frame: 20 weeks). The study lists 11 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 12 Jul 2022.