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ID

36257

Description

Multi-center Clinical Study of Guli Capsules in the Treatment of Knee Osteoarthritis; ODM derived from: https://clinicaltrials.gov/show/NCT02484508

Link

https://clinicaltrials.gov/show/NCT02484508

Keywords

Versions (1)
  1. 4/25/19 4/25/19 -
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See clinicaltrials.gov

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April 25, 2019

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Creative Commons BY 4.0
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    Eligibility Knee Osteoarthritis NCT02484508

    English

    Eligibility Knee Osteoarthritis NCT02484508

    1 forms  
    Inclusion Criteria
    Description

    Inclusion Criteria

    Alias
    UMLS CUI
    C1512693
    ages between 40 and 70 years, both gender
    Description

    Age

    Data type

    boolean

    Alias
    UMLS CUI [1]
    C0001779
    kellgren and lawrence grades of i to iii;
    Description

    Kellgren-Lawrence score

    Data type

    boolean

    Alias
    UMLS CUI [1]
    C3177117
    the subjects volunteered participate in the study and complied with the regulations and signed the written consent voluntarily.
    Description

    Protocol Compliance | Informed Consent

    Data type

    boolean

    Alias
    UMLS CUI [1]
    C0525058
    UMLS CUI [2]
    C0021430
    meet the following clinical and radiological criteria for diagnosis:
    Description

    Criteria Fulfill

    Data type

    boolean

    Alias
    UMLS CUI [1,1]
    C0243161
    UMLS CUI [1,2]
    C1550543
    clinical criteria:
    Description

    Criteria Clinical

    Data type

    boolean

    Alias
    UMLS CUI [1,1]
    C0243161
    UMLS CUI [1,2]
    C0205210
    1. most of the time have knee pain nearly a month
    Description

    Knee pain Duration

    Data type

    boolean

    Alias
    UMLS CUI [1,1]
    C0231749
    UMLS CUI [1,2]
    C0449238
    2. bone fricative
    Description

    Bone Other Coding

    Data type

    boolean

    Alias
    UMLS CUI [1,1]
    C0262950
    UMLS CUI [1,2]
    C3846158
    3. morning stiffness is less than or equal to 30 min
    Description

    Morning stiffness Duration

    Data type

    boolean

    Alias
    UMLS CUI [1,1]
    C0457086
    UMLS CUI [1,2]
    C0449238
    4. age is more than or equal to 38 years
    Description

    Age

    Data type

    boolean

    Alias
    UMLS CUI [1]
    C0001779
    5. bony enlargement. who meet (1) + (2) or (1) + (4) + (5) can be diagnosed as knee osteoarthritis.
    Description

    Bony joint enlargement

    Data type

    boolean

    Alias
    UMLS CUI [1]
    C0221610
    radiological criteria:
    Description

    Criteria Radiologic

    Data type

    boolean

    Alias
    UMLS CUI [1,1]
    C0243161
    UMLS CUI [1,2]
    C0205483
    1. most of the time have knee pain nearly a month
    Description

    Knee pain Duration

    Data type

    boolean

    Alias
    UMLS CUI [1,1]
    C0231749
    UMLS CUI [1,2]
    C0449238
    2. the x-ray showed osteophyte formation
    Description

    Osteophyte Formation X-ray

    Data type

    boolean

    Alias
    UMLS CUI [1,1]
    C1956089
    UMLS CUI [1,2]
    C1522492
    UMLS CUI [1,3]
    C0034571
    3. joint fluid examination confirmed with osteoarthritis
    Description

    Joint Fluid Examination | Osteoarthritis

    Data type

    boolean

    Alias
    UMLS CUI [1,1]
    C0039097
    UMLS CUI [1,2]
    C4321457
    UMLS CUI [2]
    C0029408
    4. age is more than or equal to 40 years
    Description

    Age

    Data type

    boolean

    Alias
    UMLS CUI [1]
    C0001779
    5. morning stiffness is less than or equal to 30 min
    Description

    Morning stiffness Duration

    Data type

    boolean

    Alias
    UMLS CUI [1,1]
    C0457086
    UMLS CUI [1,2]
    C0449238
    6. bone fricative. meet (1) + (2) or (1) + (3) + (5) + (6) or (1) + (4) + (5) +
    Description

    Bone Other Coding

    Data type

    boolean

    Alias
    UMLS CUI [1,1]
    C0262950
    UMLS CUI [1,2]
    C3846158
    (6).
    Description

    ID.18

    Data type

    boolean

    Exclusion Criteria
    Description

    Exclusion Criteria

    Alias
    UMLS CUI
    C0680251
    patient with a history of allergy to similar constituents or chemical components of the drug;
    Description

    Hypersensitivity Investigational New Drug Constituents | Hypersensitivity Investigational New Drug Component

    Data type

    boolean

    Alias
    UMLS CUI [1,1]
    C0020517
    UMLS CUI [1,2]
    C0013230
    UMLS CUI [1,3]
    C0729650
    UMLS CUI [2,1]
    C0020517
    UMLS CUI [2,2]
    C0013230
    UMLS CUI [2,3]
    C1705248
    patients with limited liver and kidney function;
    Description

    Liver Dysfunction | Impaired kidney function

    Data type

    boolean

    Alias
    UMLS CUI [1]
    C0086565
    UMLS CUI [2]
    C0184571
    patients with hematopoietic system disease;
    Description

    Hematopoietic system disease

    Data type

    boolean

    Alias
    UMLS CUI [1]
    C0018939
    patients with diabetes, cushing's syndrome and other endocrine disorders;
    Description

    Diabetes Mellitus | Cushing Syndrome | Endocrine System Diseases

    Data type

    boolean

    Alias
    UMLS CUI [1]
    C0011849
    UMLS CUI [2]
    C0010481
    UMLS CUI [3]
    C0014130
    patients with severe heart and brain disease;
    Description

    Heart Disease Severe | Brain Disease Severe

    Data type

    boolean

    Alias
    UMLS CUI [1,1]
    C0018799
    UMLS CUI [1,2]
    C0205082
    UMLS CUI [2,1]
    C0006111
    UMLS CUI [2,2]
    C0205082
    patients with low immunity;
    Description

    Deficient immunity

    Data type

    boolean

    Alias
    UMLS CUI [1]
    C4062960
    patients directly involved with the staff in the study;
    Description

    Patients Involvement with Research Personnel

    Data type

    boolean

    Alias
    UMLS CUI [1,1]
    C0030705
    UMLS CUI [1,2]
    C1314939
    UMLS CUI [1,3]
    C0035173
    women during pregnancy or lactation;
    Description

    Pregnancy | Breast Feeding

    Data type

    boolean

    Alias
    UMLS CUI [1]
    C0032961
    UMLS CUI [2]
    C0006147
    participating in other clinical studies or participated in 3 months;
    Description

    Study Subject Participation Status

    Data type

    boolean

    Alias
    UMLS CUI [1]
    C2348568
    the investigators judged who be unfit for the study.
    Description

    Study Subject Participation Status Medically unfit

    Data type

    boolean

    Alias
    UMLS CUI [1,1]
    C2348568
    UMLS CUI [1,2]
    C3841806
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    Similar models

    Eligibility Knee Osteoarthritis NCT02484508

    1 forms
    Name
    Type
    Description | Question | Decode (Coded Value)
    Data type
    Alias
    Item Group
    C1512693 (UMLS CUI)
    Age
    Item
    ages between 40 and 70 years, both gender
    boolean
    C0001779 (UMLS CUI [1])
    Kellgren-Lawrence score
    Item
    kellgren and lawrence grades of i to iii;
    boolean
    C3177117 (UMLS CUI [1])
    Protocol Compliance | Informed Consent
    Item
    the subjects volunteered participate in the study and complied with the regulations and signed the written consent voluntarily.
    boolean
    C0525058 (UMLS CUI [1])
    C0021430 (UMLS CUI [2])
    Criteria Fulfill
    Item
    meet the following clinical and radiological criteria for diagnosis:
    boolean
    C0243161 (UMLS CUI [1,1])
    C1550543 (UMLS CUI [1,2])
    Criteria Clinical
    Item
    clinical criteria:
    boolean
    C0243161 (UMLS CUI [1,1])
    C0205210 (UMLS CUI [1,2])
    Knee pain Duration
    Item
    1. most of the time have knee pain nearly a month
    boolean
    C0231749 (UMLS CUI [1,1])
    C0449238 (UMLS CUI [1,2])
    Bone Other Coding
    Item
    2. bone fricative
    boolean
    C0262950 (UMLS CUI [1,1])
    C3846158 (UMLS CUI [1,2])
    Morning stiffness Duration
    Item
    3. morning stiffness is less than or equal to 30 min
    boolean
    C0457086 (UMLS CUI [1,1])
    C0449238 (UMLS CUI [1,2])
    Age
    Item
    4. age is more than or equal to 38 years
    boolean
    C0001779 (UMLS CUI [1])
    Bony joint enlargement
    Item
    5. bony enlargement. who meet (1) + (2) or (1) + (4) + (5) can be diagnosed as knee osteoarthritis.
    boolean
    C0221610 (UMLS CUI [1])
    Criteria Radiologic
    Item
    radiological criteria:
    boolean
    C0243161 (UMLS CUI [1,1])
    C0205483 (UMLS CUI [1,2])
    Knee pain Duration
    Item
    1. most of the time have knee pain nearly a month
    boolean
    C0231749 (UMLS CUI [1,1])
    C0449238 (UMLS CUI [1,2])
    Osteophyte Formation X-ray
    Item
    2. the x-ray showed osteophyte formation
    boolean
    C1956089 (UMLS CUI [1,1])
    C1522492 (UMLS CUI [1,2])
    C0034571 (UMLS CUI [1,3])
    Joint Fluid Examination | Osteoarthritis
    Item
    3. joint fluid examination confirmed with osteoarthritis
    boolean
    C0039097 (UMLS CUI [1,1])
    C4321457 (UMLS CUI [1,2])
    C0029408 (UMLS CUI [2])
    Age
    Item
    4. age is more than or equal to 40 years
    boolean
    C0001779 (UMLS CUI [1])
    Morning stiffness Duration
    Item
    5. morning stiffness is less than or equal to 30 min
    boolean
    C0457086 (UMLS CUI [1,1])
    C0449238 (UMLS CUI [1,2])
    Bone Other Coding
    Item
    6. bone fricative. meet (1) + (2) or (1) + (3) + (5) + (6) or (1) + (4) + (5) +
    boolean
    C0262950 (UMLS CUI [1,1])
    C3846158 (UMLS CUI [1,2])
    ID.18
    Item
    (6).
    boolean
    Item Group
    C0680251 (UMLS CUI)
    Hypersensitivity Investigational New Drug Constituents | Hypersensitivity Investigational New Drug Component
    Item
    patient with a history of allergy to similar constituents or chemical components of the drug;
    boolean
    C0020517 (UMLS CUI [1,1])
    C0013230 (UMLS CUI [1,2])
    C0729650 (UMLS CUI [1,3])
    C0020517 (UMLS CUI [2,1])
    C0013230 (UMLS CUI [2,2])
    C1705248 (UMLS CUI [2,3])
    Liver Dysfunction | Impaired kidney function
    Item
    patients with limited liver and kidney function;
    boolean
    C0086565 (UMLS CUI [1])
    C0184571 (UMLS CUI [2])
    Hematopoietic system disease
    Item
    patients with hematopoietic system disease;
    boolean
    C0018939 (UMLS CUI [1])
    Diabetes Mellitus | Cushing Syndrome | Endocrine System Diseases
    Item
    patients with diabetes, cushing's syndrome and other endocrine disorders;
    boolean
    C0011849 (UMLS CUI [1])
    C0010481 (UMLS CUI [2])
    C0014130 (UMLS CUI [3])
    Heart Disease Severe | Brain Disease Severe
    Item
    patients with severe heart and brain disease;
    boolean
    C0018799 (UMLS CUI [1,1])
    C0205082 (UMLS CUI [1,2])
    C0006111 (UMLS CUI [2,1])
    C0205082 (UMLS CUI [2,2])
    Deficient immunity
    Item
    patients with low immunity;
    boolean
    C4062960 (UMLS CUI [1])
    Patients Involvement with Research Personnel
    Item
    patients directly involved with the staff in the study;
    boolean
    C0030705 (UMLS CUI [1,1])
    C1314939 (UMLS CUI [1,2])
    C0035173 (UMLS CUI [1,3])
    Pregnancy | Breast Feeding
    Item
    women during pregnancy or lactation;
    boolean
    C0032961 (UMLS CUI [1])
    C0006147 (UMLS CUI [2])
    Study Subject Participation Status
    Item
    participating in other clinical studies or participated in 3 months;
    boolean
    C2348568 (UMLS CUI [1])
    Study Subject Participation Status Medically unfit
    Item
    the investigators judged who be unfit for the study.
    boolean
    C2348568 (UMLS CUI [1,1])
    C3841806 (UMLS CUI [1,2])
    Back to the top of the page 

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