ID

37094

Beschreibung

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

Stichworte

Versionen (2)
  1. 03.07.19 03.07.19 -
  2. 03.07.19 03.07.19 -
Rechteinhaber

See clinicaltrials.gov

Hochgeladen am

3. Juli 2019

DOI

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Lizenz

Creative Commons BY 4.0
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Eligibility Rheumatoid Arthritis NCT02029599

Englisch

Eligibility Rheumatoid Arthritis NCT02029599

1 Formulare  
Inclusion Criteria
Beschreibung

Inclusion Criteria

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

Rheumatoid Arthritis

Datentyp

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。
Beschreibung

Arthralgia Diagnosis Traditional Chinese Medicine | Other Coding

Datentyp

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).
Beschreibung

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

Datentyp

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.
Beschreibung

Age

Datentyp

boolean

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

Joint function Grade

Datentyp

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.
Beschreibung

Informed Consent

Datentyp

boolean

Alias
UMLS CUI [1]
C0021430
Exclusion Criteria
Beschreibung

Exclusion Criteria

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

Lupus Erythematosus, Systemic | Sicca Syndrome | Severe osteoarthropathy

Datentyp

boolean

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

Rheumatoid Arthritis Severe

Datentyp

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).
Beschreibung

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

Datentyp

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.
Beschreibung

Pregnancy | Breast Feeding | Pregnancy, Planned

Datentyp

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.
Beschreibung

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

Datentyp

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.
Beschreibung

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

Datentyp

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.
Beschreibung

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

Datentyp

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
Beschreibung

Study Subject Participation Status Inappropriate

Datentyp

boolean

Alias
UMLS CUI [1,1]
C2348568
UMLS CUI [1,2]
C1548788
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Ähnliche Modelle

Eligibility Rheumatoid Arthritis NCT02029599

1 Formulare
Name
Typ
Description | Question | Decode (Coded Value)
Datentyp
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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