Acupuncture Study on Rheumatoid Arthritis, Monitoring Microbiome and Blood
NCT ID: NCT01619176
Last Updated: 2023-11-13
Study Results
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View full resultsBasic Information
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COMPLETED
NA
10 participants
INTERVENTIONAL
2012-10-31
2014-12-31
Brief Summary
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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.
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Detailed Description
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Conditions
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Study Design
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NON_RANDOMIZED
SINGLE_GROUP
BASIC_SCIENCE
NONE
Study Groups
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Acupuncture
Acupuncture plus conventional treatment (methotrexate+leflunomide+non-steroid anti-inflammatory drugs)
methotrexate
methotrexate: 7.5mg/week to 15mg/week for 3 months
non-steroidal anti-inflammatory drug (NSAID)
NSAID: 100mg twice a day for 3 months
leflunomide
leflunomide: 20mg/day for 3 months
Acupuncture
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.
Control
Conventional treatment (methotrexate+leflunomide+non-steroid anti-inflammatory drugs)
methotrexate
methotrexate: 7.5mg/week to 15mg/week for 3 months
non-steroidal anti-inflammatory drug (NSAID)
NSAID: 100mg twice a day for 3 months
leflunomide
leflunomide: 20mg/day for 3 months
Interventions
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methotrexate
methotrexate: 7.5mg/week to 15mg/week for 3 months
non-steroidal anti-inflammatory drug (NSAID)
NSAID: 100mg twice a day for 3 months
leflunomide
leflunomide: 20mg/day for 3 months
methotrexate
methotrexate: 7.5mg/week to 15mg/week for 3 months
non-steroidal anti-inflammatory drug (NSAID)
NSAID: 100mg twice a day for 3 months
leflunomide
leflunomide: 20mg/day for 3 months
Acupuncture
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.
Eligibility Criteria
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Inclusion Criteria
* diagnosed for RA according to ACR(1987)
* the patient should be in the active stage of the disease, defined as：
1. swollen joints \>3
2. tender joints \> 5
3. 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:
1. Hemoglobin (Hb)\>=85g/L
2. White cell \>=3.5 10+9/L
3. Platelets \>= 100 10+9/L
4. 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)
5. Kidney function: Serum creatinine (Cr) level should be less than ULN.
6. 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
* 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.
18 Years
65 Years
FEMALE
Yes
Sponsors
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Shanghai Guanghua Hospital of Integrated Traditional Chinese and Western Medicine
OTHER
Chinese Academy of Sciences
OTHER_GOV
Responsible Party
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Christine Nardini
Principal Investigator
Principal Investigators
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Christine Nardini, PhD
Role: STUDY_CHAIR
Key laboratory of Computational Biology,Chines Academy of Sciences-Max Planck Institute-CAS MPG PICB
Christine Nardini, PhD
Role: STUDY_CHAIR
Consiglio Nazionale delle Ricerche Istituto per le Applicazioni del Calcolo "Mauro Picone"
Yuanhua Liu
Role: PRINCIPAL_INVESTIGATOR
Shanghai Institute of Biochemistry and Cell Biology, CAS, Shanghai, PRC
Yongying Liang
Role: PRINCIPAL_INVESTIGATOR
Guanghua Hospital, Shanghai, PRC
Xiaoyuan Zhou
Role: PRINCIPAL_INVESTIGATOR
Group of Clinical Genomic Networks, Shanghai Institutes for Biological Sciences, CAS-MPG, China
Jennifer E. Dent
Role: PRINCIPAL_INVESTIGATOR
Group of Clinical Genomic Networks, Shanghai Institutes for Biological Sciences, CAS-MPG, China
Ting Jiang
Role: PRINCIPAL_INVESTIGATOR
Department of Neurology, University of California, San Francisco, USA
Ding Qin
Role: PRINCIPAL_INVESTIGATOR
Guanghua Hospital, Shanghai, PRC
Youtao Lu
Role: PRINCIPAL_INVESTIGATOR
Group of Clinical Genomic Networks, Shanghai Institutes for Biological Sciences, CAS-MPG, China
Dongyi He
Role: STUDY_DIRECTOR
Guanghua Hospital, Shanghai, PRC
Locations
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Shanghai GuangHua Hospital of integrated traditional and western medicine
Shanghai, Shanghai Municipality, China
Countries
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References
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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 Documents
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Document Type: Individual Participant Data Set
View DocumentRelated Links
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Other Identifiers
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acumicro
Identifier Type: -
Identifier Source: org_study_id
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