ID

37094

Descrição

The Efficacy and Safety of Fang yi Qing Feng Shi Granules in Subjects With Rheumatoid Arthritis; ODM derived from: https://clinicaltrials.gov/show/NCT02029599

Link

https://clinicaltrials.gov/show/NCT02029599

Palavras-chave

Versões (2)
  1. 03/07/2019 03/07/2019 -
  2. 03/07/2019 03/07/2019 -
Titular dos direitos

See clinicaltrials.gov

Transferido a

3 de julho de 2019

DOI

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Licença

Creative Commons BY 4.0
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Eligibility Rheumatoid Arthritis NCT02029599

Inglês

Eligibility Rheumatoid Arthritis NCT02029599

1 Formulários  
Inclusion Criteria
Descrição

Inclusion Criteria

Alias
UMLS CUI
C1512693
1. subjects have the diagnosis of rheumatoid arthritis in active state.
Descrição

Rheumatoid Arthritis

Tipo de dados

boolean

Alias
UMLS CUI [1]
C0003873
2. subjects have the traditional chinese medicine (tcm) diagnosis ofarthralgic syndrome with the sign of dampness obstructing connecting vessel。
Descrição

Arthralgia Diagnosis Traditional Chinese Medicine | Other Coding

Tipo de dados

boolean

Alias
UMLS CUI [1,1]
C0003862
UMLS CUI [1,2]
C0011900
UMLS CUI [1,3]
C0025124
UMLS CUI [2]
C3846158
3. subjects must stop the medicine at least three month，which is diseases modifying anti-rheumatic drugs(including glucocorticoids).
Descrição

Disease-Modifying Antirheumatic Drugs To be stopped | Glucocorticoids To be stopped

Tipo de dados

boolean

Alias
UMLS CUI [1,1]
C0242708
UMLS CUI [1,2]
C1272691
UMLS CUI [2,1]
C0017710
UMLS CUI [2,2]
C1272691
4. male or female subjects, between the ages of 18 and 65 years old.
Descrição

Age

Tipo de dados

boolean

Alias
UMLS CUI [1]
C0001779
5. joint function grading and ray classification are both in ⅰ～ⅲ.
Descrição

Joint function Grade

Tipo de dados

boolean

Alias
UMLS CUI [1,1]
C1535551
UMLS CUI [1,2]
C0441800
6. subjects agree to participate in this study and sign the informed consent form.
Descrição

Informed Consent

Tipo de dados

boolean

Alias
UMLS CUI [1]
C0021430
Exclusion Criteria
Descrição

Exclusion Criteria

Alias
UMLS CUI
C0680251
1. subjects with systemic lupus erythematosus,sicca syndrome, or severe osteoarthropathy will be excluded.
Descrição

Lupus Erythematosus, Systemic | Sicca Syndrome | Severe osteoarthropathy

Tipo de dados

boolean

Alias
UMLS CUI [1]
C0024141
UMLS CUI [2]
C0086981
UMLS CUI [3]
C1969350
2. subjects with severe rheumatic arthritis are loss of ability
Descrição

Rheumatoid Arthritis Severe

Tipo de dados

boolean

Alias
UMLS CUI [1,1]
C0003873
UMLS CUI [1,2]
C0205082
3. allergic to test drugs(basic treatment or drug combination),allergic constitution(allergic to two or more drugs).
Descrição

Hypersensitivity Investigational New Drugs | Hypersensitivity Drug Combinations Investigational | Patient constitution allergic | Hypersensitivity Pharmaceutical Preparations Quantity

Tipo de dados

boolean

Alias
UMLS CUI [1,1]
C0020517
UMLS CUI [1,2]
C0013230
UMLS CUI [2,1]
C0020517
UMLS CUI [2,2]
C0013162
UMLS CUI [2,3]
C1517586
UMLS CUI [3,1]
C0683521
UMLS CUI [3,2]
C0700624
UMLS CUI [4,1]
C0020517
UMLS CUI [4,2]
C0013227
UMLS CUI [4,3]
C1265611
4. female subject who was pregnant or breast-feeding or considering becoming pregnant.
Descrição

Pregnancy | Breast Feeding | Pregnancy, Planned

Tipo de dados

boolean

Alias
UMLS CUI [1]
C0032961
UMLS CUI [2]
C0006147
UMLS CUI [3]
C0032992
5. subjects with sever diseases in cardiovascular, brain, lung, liver, kidney and hematopoietic system.
Descrição

Cardiovascular Diseases Severe | Brain Diseases Severe | Lung diseases Severe | Liver diseases Severe | Kidney Diseases Severe | Hematopoietic System Disease Severe

Tipo de dados

boolean

Alias
UMLS CUI [1,1]
C0007222
UMLS CUI [1,2]
C0205082
UMLS CUI [2,1]
C0006111
UMLS CUI [2,2]
C0205082
UMLS CUI [3,1]
C0024115
UMLS CUI [3,2]
C0205082
UMLS CUI [4,1]
C0023895
UMLS CUI [4,2]
C0205082
UMLS CUI [5,1]
C0022658
UMLS CUI [5,2]
C0205082
UMLS CUI [6,1]
C0018957
UMLS CUI [6,2]
C0012634
UMLS CUI [6,3]
C0205082
6. the liver function (alt,ast) and kidney function（bun,cr）is higher than normal.
Descrição

Liver function | Alanine aminotransferase increased | Aspartate aminotransferase increased | Renal function | Blood urea increased | Serum creatinine raised

Tipo de dados

boolean

Alias
UMLS CUI [1]
C0232741
UMLS CUI [2]
C0151905
UMLS CUI [3]
C0151904
UMLS CUI [4]
C0232804
UMLS CUI [5]
C0151539
UMLS CUI [6]
C0700225
7. the blood routine (leukocyte count,platelet count)is lower than normal.
Descrição

Hematologic function | White blood cell count decreased | Decreased platelet count

Tipo de dados

boolean

Alias
UMLS CUI [1]
C0221130
UMLS CUI [2]
C0750394
UMLS CUI [3]
C0392386
8. subject considered by the investigator, for any reason, to be an unsuitable candidate for the study
Descrição

Study Subject Participation Status Inappropriate

Tipo de dados

boolean

Alias
UMLS CUI [1,1]
C2348568
UMLS CUI [1,2]
C1548788
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Similar models

Eligibility Rheumatoid Arthritis NCT02029599

1 Formulários
Name
Tipo
Description | Question | Decode (Coded Value)
Tipo de dados
Alias
Item Group
C1512693 (UMLS CUI)
Rheumatoid Arthritis
Item
1. subjects have the diagnosis of rheumatoid arthritis in active state.
boolean
C0003873 (UMLS CUI [1])
Arthralgia Diagnosis Traditional Chinese Medicine | Other Coding
Item
2. subjects have the traditional chinese medicine (tcm) diagnosis ofarthralgic syndrome with the sign of dampness obstructing connecting vessel。
boolean
C0003862 (UMLS CUI [1,1])
C0011900 (UMLS CUI [1,2])
C0025124 (UMLS CUI [1,3])
C3846158 (UMLS CUI [2])
Disease-Modifying Antirheumatic Drugs To be stopped | Glucocorticoids To be stopped
Item
3. subjects must stop the medicine at least three month，which is diseases modifying anti-rheumatic drugs(including glucocorticoids).
boolean
C0242708 (UMLS CUI [1,1])
C1272691 (UMLS CUI [1,2])
C0017710 (UMLS CUI [2,1])
C1272691 (UMLS CUI [2,2])
Age
Item
4. male or female subjects, between the ages of 18 and 65 years old.
boolean
C0001779 (UMLS CUI [1])
Joint function Grade
Item
5. joint function grading and ray classification are both in ⅰ～ⅲ.
boolean
C1535551 (UMLS CUI [1,1])
C0441800 (UMLS CUI [1,2])
Informed Consent
Item
6. subjects agree to participate in this study and sign the informed consent form.
boolean
C0021430 (UMLS CUI [1])
Item Group
C0680251 (UMLS CUI)
Lupus Erythematosus, Systemic | Sicca Syndrome | Severe osteoarthropathy
Item
1. subjects with systemic lupus erythematosus,sicca syndrome, or severe osteoarthropathy will be excluded.
boolean
C0024141 (UMLS CUI [1])
C0086981 (UMLS CUI [2])
C1969350 (UMLS CUI [3])
Rheumatoid Arthritis Severe
Item
2. subjects with severe rheumatic arthritis are loss of ability
boolean
C0003873 (UMLS CUI [1,1])
C0205082 (UMLS CUI [1,2])
Hypersensitivity Investigational New Drugs | Hypersensitivity Drug Combinations Investigational | Patient constitution allergic | Hypersensitivity Pharmaceutical Preparations Quantity
Item
3. allergic to test drugs(basic treatment or drug combination),allergic constitution(allergic to two or more drugs).
boolean
C0020517 (UMLS CUI [1,1])
C0013230 (UMLS CUI [1,2])
C0020517 (UMLS CUI [2,1])
C0013162 (UMLS CUI [2,2])
C1517586 (UMLS CUI [2,3])
C0683521 (UMLS CUI [3,1])
C0700624 (UMLS CUI [3,2])
C0020517 (UMLS CUI [4,1])
C0013227 (UMLS CUI [4,2])
C1265611 (UMLS CUI [4,3])
Pregnancy | Breast Feeding | Pregnancy, Planned
Item
4. female subject who was pregnant or breast-feeding or considering becoming pregnant.
boolean
C0032961 (UMLS CUI [1])
C0006147 (UMLS CUI [2])
C0032992 (UMLS CUI [3])
Cardiovascular Diseases Severe | Brain Diseases Severe | Lung diseases Severe | Liver diseases Severe | Kidney Diseases Severe | Hematopoietic System Disease Severe
Item
5. subjects with sever diseases in cardiovascular, brain, lung, liver, kidney and hematopoietic system.
boolean
C0007222 (UMLS CUI [1,1])
C0205082 (UMLS CUI [1,2])
C0006111 (UMLS CUI [2,1])
C0205082 (UMLS CUI [2,2])
C0024115 (UMLS CUI [3,1])
C0205082 (UMLS CUI [3,2])
C0023895 (UMLS CUI [4,1])
C0205082 (UMLS CUI [4,2])
C0022658 (UMLS CUI [5,1])
C0205082 (UMLS CUI [5,2])
C0018957 (UMLS CUI [6,1])
C0012634 (UMLS CUI [6,2])
C0205082 (UMLS CUI [6,3])
Liver function | Alanine aminotransferase increased | Aspartate aminotransferase increased | Renal function | Blood urea increased | Serum creatinine raised
Item
6. the liver function (alt,ast) and kidney function（bun,cr）is higher than normal.
boolean
C0232741 (UMLS CUI [1])
C0151905 (UMLS CUI [2])
C0151904 (UMLS CUI [3])
C0232804 (UMLS CUI [4])
C0151539 (UMLS CUI [5])
C0700225 (UMLS CUI [6])
Hematologic function | White blood cell count decreased | Decreased platelet count
Item
7. the blood routine (leukocyte count,platelet count)is lower than normal.
boolean
C0221130 (UMLS CUI [1])
C0750394 (UMLS CUI [2])
C0392386 (UMLS CUI [3])
Study Subject Participation Status Inappropriate
Item
8. subject considered by the investigator, for any reason, to be an unsuitable candidate for the study
boolean
C2348568 (UMLS CUI [1,1])
C1548788 (UMLS CUI [1,2])
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