Rheumatoid ArthritisNCT01619176
Acupuncture Study on Rheumatoid Arthritis, Monitoring Microbiome and Blood
A study testing methotrexate, non-steroidal anti-inflammatory drug (NSAID) and leflunomide in people with Rheumatoid Arthritis, run by Chinese Academy of Sciences at 1 site in China.
Trial summary
Acupuncture is used and recommended by the WHO for the treatment of Rheumatoid Arthritis. The molecular bases of this recommendation are not known, the investigators want to compare with the usage of high-throughput molecular technologies the variations occurring in patients treated with acupuncture and conventional… Read more about this study
- Who is it for?
- Ages 18 to 65 years, women onlyHealthy volunteers can take part
- Conditions the study is for
- Rheumatoid Arthritis
- What is being tested?
- methotrexate, non-steroidal anti-inflammatory drug (NSAID) and leflunomide
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 10 participants
- Where
- 1 siteChina
- Study dates
- Oct 2012to Dec 2014
- Phase
- Interventional
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
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 65 years
- Women only
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- The patient should be diagnosed as the first or second stage of rheumatoid Arthritis (RA) and checked with X ray for additional diagnose.
- diagnosed for RA according to ACR(1987)
- the patient should be in the active stage of the disease, defined as：
- swollen joints >3
- tender joints > 5
- any one of the following： (c1.) morning stiffness lasting more than 45 minutes (c2.) Erythrocyte Sedimentation Rate (ESR) >= 28mm/h (c3.) C-reactive protein (CRP)>= 12mg/L
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- Should not be resistant to MTX nor leflunomide
- Blood test should satisfy:
- Hemoglobin (Hb)>=85g/L
- White cell >=3.5 10+9/L
- Platelets >= 100 10+9/L
- Liver function: serum alanine aminotransaminase (ALT), aspartate transaminase (AST) and total bilirubin (TBil) should be less than 1.5 times the upper limit of normal (ULN)
- Kidney function: Serum creatinine (Cr) level should be less than ULN.
- Pregnancy test should be negative
- should be positive for anti-cyclic citrullinated protein antibodies (anti-CCP).
- should agree to sign the informed consent
Who cannot join
- Serious diseases affecting liver, kidney, heart and lung, or diseases related to hematologic，endocrine and nervous systems. .
- Be treated by MTX or Leflunomide in the last 3 months.
- Be treated with cortical hormone （could be intramuscular injection, intravenous injection or injection to articular cavity） in the last 4 weeks.
- Be treated with biological agents, such as antagonist of TNF-alpha,IL-6, and CD20 mono antibody in the last 3 months.
- Be treated by chronic medicine, such as immunosuppressive agent, Penicillamine, chloroquine and gold based Disease-modifying antirheumatic drugs (DMARDs) in the last 3 months.
- Pregnant and breast-feeding woman
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- Having history of serious drug allergy
- In the acute or chronic phase of infection (such as lung diseases)
- Easy bleeding patients or patients with local skin infection (only for acupuncture)
- The patients cannot accept acupuncture (only for acupuncture)
- Be treated with acupuncture in the past 3 months（only for acupuncture）.
- No pregnant and breast-feeding woman.
- No history of serious drug allergy.
Trial locations and contacts
1 site in 1 country.
China1 site
Shanghai GuangHua Hospital of integrated traditional and western medicine
Shanghai, Shanghai Municipality, 200052
About this study
Official title: Non Inferiority Trial for the Study of Acupuncture on Rheumatoid Arthritis
Acupuncture is used and recommended by the WHO for the treatment of Rheumatoid Arthritis.
The molecular bases of this recommendation are not known, the investigators want to compare with the usage of high-throughput molecular technologies the variations occurring in patients treated with acupuncture and conventional treatment with the ones treated with conventional treatment only. The investigators observe the variations in blood and in the gut microbiome.
- Conditions
- Rheumatoid Arthritis
- Being tested
- methotrexate, non-steroidal anti-inflammatory drug (NSAID), leflunomide, Acupuncture
- Keywords
- Rheumatoid Arthritis, blood, gut intestinal microbiome
- Medical subject headings
- Arthritis, Rheumatoid
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
methotrexateDrug
methotrexate: 7.5mg/week to 15mg/week for 3 months
non-steroidal anti-inflammatory drug (NSAID)Drug
NSAID: 100mg twice a day for 3 months
leflunomideDrug
leflunomide: 20mg/day for 3 months
methotrexateDrug
methotrexate: 7.5mg/week to 15mg/week for 3 months
non-steroidal anti-inflammatory drug (NSAID)Drug
NSAID: 100mg twice a day for 3 months
leflunomideDrug
leflunomide: 20mg/day for 3 months
AcupunctureProcedure or surgery
30 minutes acupuncture every other day for 3 months.
Basic acupoints: Zusanli, st36; Taixi，KI3）; Shenxu, BL23 Additional acupoints due to personal condition: Waiguan，SJ5; Baxie，Ex-UE9;Yinlingquan，(SP9）; Quchi，LI11; Yanglingquan，GB34; Xuehai，SP10; Dazhu，BL11; Dazhui，DU14; Pixu，BL20.
| Study group | Role | What they receive |
|---|---|---|
| Acupuncture | Experimental | Acupuncture plus conventional treatment (methotrexate+leflunomide+non-steroid anti-inflammatory drugs) Receives: Drug: methotrexate; Drug: non-steroidal anti-inflammatory drug (NSAID); Drug: leflunomide; Procedure: Acupuncture |
| Control | Active comparator | Conventional treatment (methotrexate+leflunomide+non-steroid anti-inflammatory drugs) Receives: Drug: methotrexate; Drug: non-steroidal anti-inflammatory drug (NSAID); Drug: leflunomide |
What is being measured
The primary outcome is the main question the study is designed to answer.
ACR20 Response Rate at 3 Weeks
ACR criteria stands for: American College of Rheumatology Criteria. ACR criteria measures improvement in tender or swollen joint counts and improvement in three of the following five parameters:
acute phase reactant (such as sedimentation rate) patient assessment physician assessment pain scale disability/functional questionnaire
The number indicates the percentage of improvement in tender or swollen joint counts as well percentage improvement in three of the other five criteria (patient's assessment of pain, a physician's global assessment of disease, a patient's global assessment of disease, physical function as assessed by the Health Assessment Questionnaire-Disability Index (HAQ-DI), and the level of acute-phase reactant)
Measured: From baseline to 3 weeks
ACR20 Response Rate at 3 Months
ACR criteria stands for: American College of Rheumatology Criteria. ACR criteria measures improvement in tender or swollen joint counts and improvement in three of the following five parameters:
acute phase reactant (such as sedimentation rate) patient assessment physician assessment pain scale disability/functional questionnaire
The number indicates the percentage of improvement in tender or swollen joint counts as well percentage improvement in three of the other five criteria (patient's assessment of pain, a physician's global assessment of disease, a patient's global assessment of disease, physical function as assessed by the Health Assessment Questionnaire-Disability Index (HAQ-DI), and the level of acute-phase reactant)
Measured: From baseline to three months
Secondary outcomes (7)
ACR50 Response Rate at 3 Weeks
ACR criteria stands for: American College of Rheumatology Criteria. ACR criteria measures improvement in tender or swollen joint counts and improvement in three of the following five parameters:
acute phase reactant (such as sedimentation rate) patient assessment physician assessment pain scale disability/functional questionnaire
The number indicates the percentage of improvement in tender or swollen joint counts as well percentage improvement in three of the other five criteria (patient's assessment of pain, a physician's global assessment of disease, a patient's global assessment of disease, physical function as assessed by the Health Assessment Questionnaire-Disability Index (HAQ-DI), and the level of acute-phase reactant)
Measured: From baseline to 3 weeks
ACR50 Response Rate at 3 Months
ACR criteria stands for: American College of Rheumatology Criteria. ACR criteria measures improvement in tender or swollen joint counts and improvement in three of the following five parameters:
acute phase reactant (such as sedimentation rate) patient assessment physician assessment pain scale disability/functional questionnaire
The number indicates the percentage of improvement in tender or swollen joint counts as well percentage improvement in three of the other five criteria (patient's assessment of pain, a physician's global assessment of disease, a patient's global assessment of disease, physical function as assessed by the Health Assessment Questionnaire-Disability Index (HAQ-DI), and the level of acute-phase reactant)
Measured: From baseline to three months
ACR70 Response Rate at 3 Weeks
ACR criteria stands for: American College of Rheumatology Criteria. ACR criteria measures improvement in tender or swollen joint counts and improvement in three of the following five parameters:
acute phase reactant (such as sedimentation rate) patient assessment physician assessment pain scale disability/functional questionnaire
The number indicates the percentage of improvement in tender or swollen joint counts as well percentage improvement in three of the other five criteria (patient's assessment of pain, a physician's global assessment of disease, a patient's global assessment of disease, physical function as assessed by the Health Assessment Questionnaire-Disability Index (HAQ-DI), and the level of acute-phase reactant)
Measured: From baseline to 3 weeks
ACR70 Response Rate at 3 Months
ACR criteria stands for: American College of Rheumatology Criteria. ACR criteria measures improvement in tender or swollen joint counts and improvement in three of the following five parameters:
acute phase reactant (such as sedimentation rate) patient assessment physician assessment pain scale disability/functional questionnaire
The number indicates the percentage of improvement in tender or swollen joint counts as well percentage improvement in three of the other five criteria (patient's assessment of pain, a physician's global assessment of disease, a patient's global assessment of disease, physical function as assessed by the Health Assessment Questionnaire-Disability Index (HAQ-DI), and the level of acute-phase reactant)
Measured: From baseline to three months
DAS28 at Baseline
The DAS28 (disease activity score) considers 28 tender and swollen joint counts, general health (GH; patient assessment of disease activity using a 100 mm visual analogue scale (VAS) with 0 = best, 100 = worst), plus levels of an acute phase reactant (either the level of erythrocyte sedimentation rate ESR (mm/h) or C-reactive protein CRP (mg/litre)). DAS28 values were calculated as follows: DAS28 (CRP) = 0.56*√(TJC28) +0.28*√(SJC28)+0.014*GH+0.36*ln(CRP+1)+0.96; DAS28 (ESR) = 0.56*√(TJC28)+0.28*√(SJC28)+0.014*GH+0.70*ln(ESR), where TJC = tender joint count and SJC = swollen joint count.
The scale does not have bounds. DAS28 total score < 2,6 means remission DAS28 total score ranged between 2.6-3.2 means inactive disease; DAS28 total score ranged between 3.3-5.1 means moderate disease activity; DAS28 total score >5.1 means very active disease
Measured: At baseline
DAS28 at 3 Weeks
The DAS28 (disease activity score) considers 28 tender and swollen joint counts, general health (GH; patient assessment of disease activity using a 100 mm visual analogue scale (VAS) with 0 = best, 100 = worst), plus levels of an acute phase reactant (either the level of erythrocyte sedimentation rate ESR (mm/h) or C-reactive protein CRP (mg/litre)). DAS28 values were calculated as follows: DAS28 (CRP) = 0.56*√(TJC28) +0.28*√(SJC28)+0.014*GH+0.36*ln(CRP+1)+0.96; DAS28 (ESR) = 0.56*√(TJC28)+0.28*√(SJC28)+0.014*GH+0.70*ln(ESR), where TJC = tender joint count and SJC = swollen joint count.
The scale does not have bounds. DAS28 total score < 2,6 means remission DAS28 total score ranged between 0-3.2 means inactive disease; DAS28 total score ranged between 3.3-5.1 means moderate disease activity; DAS28 total score >5.1 means very active disease
Measured: At 3 weeks
DAS28 at 3 Months
The DAS28 (disease activity score) considers 28 tender and swollen joint counts, general health (GH; patient assessment of disease activity using a 100 mm visual analogue scale (VAS) with 0 = best, 100 = worst), plus levels of an acute phase reactant (either the level of erythrocyte sedimentation rate ESR (mm/h) or C-reactive protein CRP (mg/litre)). DAS28 values were calculated as follows: DAS28 (CRP) = 0.56*√(TJC28) +0.28*√(SJC28)+0.014*GH+0.36*ln(CRP+1)+0.96; DAS28 (ESR) = 0.56*√(TJC28)+0.28*√(SJC28)+0.014*GH+0.70*ln(ESR), where TJC = tender joint count and SJC = swollen joint count.
The scale does not have bounds. DAS28 total score < 2,6 means remission DAS28 total score ranged between 0-3.2 means inactive disease; DAS28 total score ranged between 3.3-5.1 means moderate disease activity; DAS28 total score >5.1 means very active disease
Measured: At 3 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted14 Jun 2012 (estimated)
- Study startOct 2012
- Primary completionDec 2014
- Study completionDec 2014
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Rheumatoid 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
- Basic science
- Allocation
- Non-randomised
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 10 participants (actual)
Sponsor and investigators
- Lead sponsor
- Chinese Academy of Sciences
- Sponsor type
- Other government
- Collaborators
- Shanghai Guanghua Hospital of Integrated Traditional Chinese and Western Medicine
- Responsible party
- Principal investigator, Christine Nardini, Chinese Academy of Sciences
- Investigators
- Christine Nardini, PhD, Study chair, Key laboratory of Computational Biology,Chines Academy of Sciences-Max Planck Institute-CAS MPG PICBChristine Nardini, PhD, Study chair, Consiglio Nazionale delle Ricerche Istituto per le Applicazioni del Calcolo "Mauro Picone"Yuanhua Liu, Principal investigator, Shanghai Institute of Biochemistry and Cell Biology, CAS, Shanghai, PRCYongying Liang, Principal investigator, Guanghua Hospital, Shanghai, PRCXiaoyuan Zhou, Principal investigator, Group of Clinical Genomic Networks, Shanghai Institutes for Biological Sciences, CAS-MPG, ChinaJennifer E. Dent, Principal investigator, Group of Clinical Genomic Networks, Shanghai Institutes for Biological Sciences, CAS-MPG, ChinaTing Jiang, Principal investigator, Department of Neurology, University of California, San Francisco, USADing Qin, Principal investigator, Guanghua Hospital, Shanghai, PRC
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01619176
- Sponsor's protocol ID
- acumicro
- Status last verified
- Nov 2023
- First submitted
- 5 Jun 2012
- Last updated
- 13 Nov 2023
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
Publications
Liu, Y. et al. (2023). Wound Healing from Bench to Bedside: A PPPM Bridge Between Physical Therapies and Chronic Inflammation. In: Podbielska, H., Kapalla, M. (eds) Predictive, Preventive, and Personalised Medicine: From Bench to Bedside. Advances in Predictive, Preventive and Personalised Medicine, vol 17. Springer, Cham. https://doi.org/10.1007/978-3-031-34884-6_12
Study at a glance
From the registry record, last updated by the sponsor on 13 Nov 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Non Inferiority Trial for the Study of Acupuncture on Rheumatoid Arthritis
- ClinicalTrials.gov ID
- NCT01619176
- Acronym / sponsor ID
- acumicro
- Conditions
- Rheumatoid Arthritis
- Keywords
- Rheumatoid Arthritis, blood, gut intestinal microbiome
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 10 participants (actual)
- Lead sponsor
- Chinese Academy of SciencesOther government
- Collaborators
- Shanghai Guanghua Hospital of Integrated Traditional Chinese and Western Medicine
- Study start
- Oct 2012
- Primary completion
- Dec 2014 (actual)
- Study completion
- Dec 2014 (actual)
- First posted
- 14 Jun 2012 (estimated)
- Results
- Posted 8 Sep 2023
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
Acupuncture is used and recommended by the WHO for the treatment of Rheumatoid Arthritis.
The molecular bases of this recommendation are not known, the investigators want to compare with the usage of high-throughput molecular technologies the variations occurring in patients treated with acupuncture and conventional treatment with the ones treated with conventional treatment only. The investigators observe the variations in blood and in the gut microbiome.
Study design
- Primary purpose
- Basic science
- Allocation
- Non-randomised
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Acupuncture | Experimental | Drug: methotrexate, Drug: non-steroidal anti-inflammatory drug (NSAID), Drug: leflunomide, Procedure: AcupunctureAcupuncture plus conventional treatment (methotrexate+leflunomide+non-steroid anti-inflammatory drugs) |
| Control | Active comparator | Drug: methotrexate, Drug: non-steroidal anti-inflammatory drug (NSAID), Drug: leflunomideConventional treatment (methotrexate+leflunomide+non-steroid anti-inflammatory drugs) |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- Female only
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (16 listed)
- The patient should be diagnosed as the first or second stage of rheumatoid Arthritis (RA) and checked with X ray for additional diagnose.
- diagnosed for RA according to ACR(1987)
- the patient should be in the active stage of the disease, defined as：
- Should not be resistant to MTX nor leflunomide
- Blood test should satisfy:
Key exclusion criteria (13 listed)
- Serious diseases affecting liver, kidney, heart and lung, or diseases related to hematologic，endocrine and nervous systems. .
- Be treated by MTX or Leflunomide in the last 3 months.
- Be treated with cortical hormone （could be intramuscular injection, intravenous injection or injection to articular cavity） in the last 4 weeks.
- Be treated with biological agents, such as antagonist of TNF-alpha,IL-6, and CD20 mono antibody in the last 3 months.
- Be treated by chronic medicine, such as immunosuppressive agent, Penicillamine, chloroquine and gold based Disease-modifying antirheumatic drugs (DMARDs) in the last 3 months.
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 |
|---|---|---|
| methotrexatemethotrexate: 7.5mg/week to 15mg/week for 3 months | Drug | Control |
| non-steroidal anti-inflammatory drug (NSAID)NSAID: 100mg twice a day for 3 months | Drug | Control |
| leflunomideleflunomide: 20mg/day for 3 months | Drug | Control |
| methotrexatemethotrexate: 7.5mg/week to 15mg/week for 3 months | Drug | Acupuncture |
| non-steroidal anti-inflammatory drug (NSAID)NSAID: 100mg twice a day for 3 months | Drug | Acupuncture |
| leflunomideleflunomide: 20mg/day for 3 months | Drug | Acupuncture |
| Acupuncture30 minutes acupuncture every other day for 3 months. Basic acupoints: Zusanli, st36; Taixi，KI3）; Shenxu, BL23 Additional acupoints due to personal condition: Waiguan，SJ5; Baxie，Ex-UE9;Yinlingquan，(SP9）; Quchi，LI11; Yanglingquan，GB34; Xuehai，SP10; Dazhu，BL11; Dazhui，DU14; Pixu，BL20. | Procedure or surgery | Acupuncture |
Primary outcome
ACR20 Response Rate at 3 Weeks
Time frame: From baseline to 3 weeks
ACR criteria stands for: American College of Rheumatology Criteria. ACR criteria measures improvement in tender or swollen joint counts and improvement in three of the following five parameters: acute phase reactant (such as sedimentation rate) patient assessment physician assessment pain scale disability/functional questionnaire The number indicates the percentage of improvement in tender or swollen joint counts as well percentage improvement in three of the other five criteria (patient's assessment of pain, a physician's global assessment of disease, a patient's global assessment of disease, physical function as assessed by the Health Assessment Questionnaire-Disability Index (HAQ-DI), and the level of acute-phase reactant)
ACR20 Response Rate at 3 Months
Time frame: From baseline to three months
ACR criteria stands for: American College of Rheumatology Criteria. ACR criteria measures improvement in tender or swollen joint counts and improvement in three of the following five parameters: acute phase reactant (such as sedimentation rate) patient assessment physician assessment pain scale disability/functional questionnaire The number indicates the percentage of improvement in tender or swollen joint counts as well percentage improvement in three of the other five criteria (patient's assessment of pain, a physician's global assessment of disease, a patient's global assessment of disease, physical function as assessed by the Health Assessment Questionnaire-Disability Index (HAQ-DI), and the level of acute-phase reactant)
7 secondary outcomes
ACR50 Response Rate at 3 Weeks
Time frame: From baseline to 3 weeks
ACR50 Response Rate at 3 Months
Time frame: From baseline to three months
ACR70 Response Rate at 3 Weeks
Time frame: From baseline to 3 weeks
ACR70 Response Rate at 3 Months
Time frame: From baseline to three months
DAS28 at Baseline
Time frame: At baseline
DAS28 at 3 Weeks
Time frame: At 3 weeks
DAS28 at 3 Months
Time frame: At 3 months
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 13 Nov 2023.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Results publicationLiu, Y. et al. (2023). Wound Healing from Bench to Bedside: A PPPM Bridge Between Physical Therapies and Chronic Inflammation. In: Podbielska, H., Kapalla, M. (eds) Predictive, Preventive, and Personalised Medicine: From Bench to Bedside. Advances in Predictive, Preventive and Personalised Medicine, vol 17. Springer, Cham. https://doi.org/10.1007/978-3-031-34884-6_12
- Book chapterLink provided by the sponsor.
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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.
Christine Nardini, PhD study chair
Key laboratory of Computational Biology,Chines Academy of Sciences-Max Planck Institute-CAS MPG PICB
Christine Nardini, PhD study chair
Consiglio Nazionale delle Ricerche Istituto per le Applicazioni del Calcolo "Mauro Picone"
Yuanhua Liu principal investigator
Shanghai Institute of Biochemistry and Cell Biology, CAS, Shanghai, PRC
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing methotrexate, non-steroidal anti-inflammatory drug (NSAID) and leflunomide in people with Rheumatoid Arthritis, run by Chinese Academy of Sciences 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 16 inclusion and 13 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 13 Nov 2023. 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?
Yes. Results are posted in the registry (first posted 8 Sep 2023). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
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?
ACR20 Response Rate at 3 Weeks (time frame: From baseline to 3 weeks). 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?
On the ClinicalTrials.gov record for NCT01619176, which also lists 1 linked publication.
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 13 Nov 2023.