Trial · NCT01619176
Acupuncture Study on Rheumatoid Arthritis, Monitoring Microbiome and Blood
NCT01619176, Not applicable, Completed, Chinese Academy of Sciences; results first posted 2023-09-08
3 sourcestrials-2026-11-12-0.5.0
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ConductScience Library. Acupuncture Study on Rheumatoid Arthritis, Monitoring Microbiome and Blood. Trials, record NCT01619176. Release trials-2026-11-12-0.5.0, 12 Nov 2026. https://conductscience.org/library/trials/NCT01619176
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Trial
As registered on ClinicalTrials.gov, in the graph's capture of the registry.
- Title
- Acupuncture Study on Rheumatoid Arthritis, Monitoring Microbiome and Blood
- NCT number
- NCT01619176
- Status
- Completed
- Phases
- Not applicable
- Enrollment
- 10 participants, actual
- Lead sponsor
- Chinese Academy of Sciences
- Conditions
- Rheumatoid Arthritis
- Interventions
- methotrexate, non-steroidal anti-inflammatory drug (NSAID), leflunomide, methotrexate, non-steroidal anti-inflammatory drug (NSAID), leflunomide, Acupuncture
- First posted
- 2012-06-14
- Last updated
- 2023-11-13
- Results first posted
- 2023-09-08
Source ClinicalTrials.gov
Registered outcomes9
Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.
| List | Outcome | Time frame | Description |
|---|---|---|---|
| Primary | ACR20 Response Rate at 3 Weeks | 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) |
| Primary | ACR20 Response Rate at 3 Months | 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) |
| Secondary | ACR50 Response Rate at 3 Weeks | 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) |
| Secondary | ACR50 Response Rate at 3 Months | 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) |
| Secondary | ACR70 Response Rate at 3 Weeks | 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) |
| Secondary | ACR70 Response Rate at 3 Months | 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) |
| Secondary | DAS28 at Baseline | 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 |
| Secondary | DAS28 at 3 Weeks | 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 |
| Secondary | DAS28 at 3 Months | 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 |
Source ClinicalTrials.gov
Outcomes9
Each outcome the trial posted results for, in ClinicalTrials.gov's words.
| Type | Outcome | Time frame | Population | Units | Measured as |
|---|---|---|---|---|---|
| PRIMARY | ACR20 Response Rate at 3 Weeks | From baseline to 3 weeks | Participants | COUNT_OF_PARTICIPANTS | |
| PRIMARY | ACR20 Response Rate at 3 Months | From baseline to three months | Participants | COUNT_OF_PARTICIPANTS | |
| SECONDARY | ACR50 Response Rate at 3 Weeks | From baseline to 3 weeks | Participants | COUNT_OF_PARTICIPANTS | |
| SECONDARY | ACR50 Response Rate at 3 Months | From baseline to three months | Participants | COUNT_OF_PARTICIPANTS | |
| SECONDARY | ACR70 Response Rate at 3 Weeks | From baseline to 3 weeks | Participants | COUNT_OF_PARTICIPANTS | |
| SECONDARY | ACR70 Response Rate at 3 Months | From baseline to three months | Participants | COUNT_OF_PARTICIPANTS | |
| SECONDARY | DAS28 at Baseline | At baseline | units on a scale | MEAN | |
| SECONDARY | DAS28 at 3 Weeks | At 3 weeks | units on a scale | MEAN | |
| SECONDARY | DAS28 at 3 Months | At 3 months | units on a scale | MEAN |
Source ClinicalTrials.gov
Results by group18
Each measurement the trial posted, group by group, in the words and numbers it posted.
| Outcome | Group | Category | Value | Spread | Units |
|---|---|---|---|---|---|
| ACR20 Response Rate at 3 Weeks | Acupuncture | 0 | Participants | ||
| ACR20 Response Rate at 3 Weeks | Control | 1 | Participants | ||
| ACR20 Response Rate at 3 Months | Acupuncture | 5 | Participants | ||
| ACR20 Response Rate at 3 Months | Control | 3 | Participants | ||
| ACR50 Response Rate at 3 Weeks | Acupuncture | 0 | Participants | ||
| ACR50 Response Rate at 3 Weeks | Control | 1 | Participants | ||
| ACR50 Response Rate at 3 Months | Acupuncture | 2 | Participants | ||
| ACR50 Response Rate at 3 Months | Control | 1 | Participants | ||
| ACR70 Response Rate at 3 Weeks | Acupuncture | 0 | Participants | ||
| ACR70 Response Rate at 3 Weeks | Control | 0 | Participants |
1 to 10 of 18Source ClinicalTrials.gov
See all 18 results by groupParticipant flow6
How many started, completed or left each group, period by period.
| Period | Milestone | Group | Participants | Units counted |
|---|---|---|---|---|
| Overall Study | STARTED | Acupuncture | 6 | |
| Overall Study | STARTED | Control | 4 | |
| Overall Study | COMPLETED | Acupuncture | 6 | |
| Overall Study | COMPLETED | Control | 4 | |
| Overall Study | NOT COMPLETED | Acupuncture | 0 | |
| Overall Study | NOT COMPLETED | Control | 0 |
Source ClinicalTrials.gov
Adverse events0
Each adverse event the trial posted, group by group: the participants affected out of those at risk.
None in this release.
Adverse event totals6
The totals the trial posted for each group.
| Total | Group | Affected | At risk |
|---|---|---|---|
| Total, all-cause mortality | Acupuncture | ||
| Total, all-cause mortality | Control | ||
| Total, other adverse events | Acupuncture | 0 | 6 |
| Total, other adverse events | Control | 0 | 4 |
| Total, serious adverse events | Acupuncture | 0 | 6 |
| Total, serious adverse events | Control | 0 | 4 |
Source ClinicalTrials.gov
Papers0
The papers the trial lists on ClinicalTrials.gov.
None in this release.
Grants0
The grants NIH RePORTER links to the trial, newest funded first: NIH's, and some of AHRQ's, CDC's, FDA's and VA's. Each shows its title, principal investigators, organization and funder in its newest year.
None in this release.
Trial comparisons7
Comparisons of the trial's two groups, calculated by ConductScience from the counts it posted.
| Comparison | Source |
|---|---|
| Acupuncture vs Control: ACR70 Response Rate at 3 Weeks | Trial comparisons |
| Acupuncture vs Control: ACR50 Response Rate at 3 Weeks | Trial comparisons |
| Acupuncture vs Control: ACR20 Response Rate at 3 Weeks | Trial comparisons |
| Acupuncture vs Control: ACR50 Response Rate at 3 Months | Trial comparisons |
| Acupuncture vs Control: ACR70 Response Rate at 3 Months | Trial comparisons |
| Acupuncture vs Control: ACR20 Response Rate at 3 Months | Trial comparisons |
| Acupuncture vs Control: serious adverse events | Trial comparisons |
Tests0
The ConductCognition tests this trial's registered outcomes name, as ScienceGraph matched them in trial-tests-2026-11-12-0.2.1.
None in this release.
Data dates
The day each source was copied for this release.
Sources 3
- ClinicalTrials.gov's posted results, through CTTI's AACTFreely available. Acknowledgement requested
- ClinicalTrials.govNo license stated
- NIH RePORTER's clinical studies and project filesPublic domain
Each source's terms
- ClinicalTrials.gov's posted results, through CTTI's AACTClinicalTrials.gov data via Aggregate Analysis of ClinicalTrials.gov (AACT), CTTI. CTTI makes its materials freely available and requests acknowledgement. https://aact.ctti-clinicaltrials.org/documentation/299
- ClinicalTrials.govnone stated
- NIH RePORTER's clinical studies and project filesPublic domain (NIH RePORTER)
ClinicalTrials.gov's data carry an international copyright outside the United States: https://clinicaltrials.gov/about-site/terms-conditions.
For software
Read this trial from software.
The record and each of its lists are JSON, twenty rows a page. No key.
GET https://conductscience.org/api/trials/v1/NCT01619176
GET https://conductscience.org/api/trials/v1/NCT01619176/registered