N/A
Completed N=10
Acupuncture Study on Rheumatoid Arthritis, Monitoring Microbiome and Blood
Source: ClinicalTrials.gov NCT01619176 ↗Enrolled (actual)
10
Serious AEs
0.0%
Results posted
Sep 2023
Primary outcomePrimary: ACR20 Response Rate at 3 Weeks — 0; 1 Participants
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 treatment with the ones treated with conventional treatment only. The investigators observe the variations in blood and in the gut microbiome.
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY ACR20 Response Rate at 3 Weeks |
0; 1 | — |
| PRIMARY ACR20 Response Rate at 3 Months |
5; 3 | — |
| SECONDARY ACR50 Response Rate at 3 Weeks |
0; 1 | — |
| SECONDARY ACR50 Response Rate at 3 Months |
2; 1 | — |
| SECONDARY ACR70 Response Rate at 3 Weeks |
0; 0 | — |
| SECONDARY ACR70 Response Rate at 3 Months |
0; 1 | — |
| SECONDARY DAS28 at Baseline |
4.98; 6.8 | — |
| SECONDARY DAS28 at 3 Weeks |
5; 5.27 | — |
| SECONDARY DAS28 at 3 Months |
3.85; 4.5 | — |
Eligibility Criteria
Inclusion Criteria
- 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
- 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
Exclusion Criteria
- 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
- 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.
Data sourced from ClinicalTrials.gov (NCT01619176). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication. Informational only — not medical advice.