ID

44000

Description

Efficacy Study Testing Herbal Extract on Metabolic Parameters in Subjects With Type 2 Diabetes; ODM derived from: https://clinicaltrials.gov/show/NCT00499148

Link

https://clinicaltrials.gov/show/NCT00499148

Keywords

Versions (2)
  1. 7/4/17 7/4/17 -
  2. 9/20/21 9/20/21 -
Uploaded on

September 20, 2021

DOI

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License

Creative Commons BY 4.0
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Eligibility Type 2 Diabetes NCT00499148

English

Eligibility Type 2 Diabetes NCT00499148

1 forms  
Inclusion Criteria
Description

Inclusion Criteria

Alias
UMLS CUI
C1512693
type 2 diabetes
Description

Diabetes Mellitus, Non-Insulin-Dependent

Data type

boolean

Alias
UMLS CUI [1]
C0011860
between 18 and 75 years of age
Description

Age

Data type

boolean

Alias
UMLS CUI [1]
C0001779
male or non-pregnant, non-lactating female, at least 6 weeks postpartum
Description

Gender | Pregnancy Absent | Breast Feeding Absent | Postpartum Period

Data type

boolean

Alias
UMLS CUI [1]
C0079399
UMLS CUI [2,1]
C0032961
UMLS CUI [2,2]
C0332197
UMLS CUI [3,1]
C0006147
UMLS CUI [3,2]
C0332197
UMLS CUI [4]
C0086839
if of childbearing potential, is practicing birth control
Description

Childbearing Potential Contraceptive methods

Data type

boolean

Alias
UMLS CUI [1,1]
C3831118
UMLS CUI [1,2]
C0700589
bmi is more than or equal to 18kg/m2 and less than or equal to 35kg/m2
Description

Body mass index

Data type

boolean

Alias
UMLS CUI [1]
C1305855
if on anti-hyperglycemic, anti-hypertensive, lipid-lowering, or thyroid medications or hormone therapy, has been on constant dosage for at least 3 months prior to screening visit
Description

Hypoglycemic Agents Dosage Constant | Antihypertensive Agents Dosage Constant | Antilipemic agent Dosage Constant | Thyroid preparations Dosage Constant | Hormone Therapy Dosage Constant

Data type

boolean

Alias
UMLS CUI [1,1]
C0020616
UMLS CUI [1,2]
C0178602
UMLS CUI [1,3]
C1948059
UMLS CUI [2,1]
C0003364
UMLS CUI [2,2]
C0178602
UMLS CUI [2,3]
C1948059
UMLS CUI [3,1]
C0086440
UMLS CUI [3,2]
C0178602
UMLS CUI [3,3]
C1948059
UMLS CUI [4,1]
C0279175
UMLS CUI [4,2]
C0178602
UMLS CUI [4,3]
C1948059
UMLS CUI [5,1]
C0279025
UMLS CUI [5,2]
C0178602
UMLS CUI [5,3]
C1948059
Exclusion Criteria
Description

Exclusion Criteria

Alias
UMLS CUI
C0680251
uses insulin for glucose control or has type 1 diabetes
Description

Insulin | Glucose control | Diabetes Mellitus, Insulin-Dependent

Data type

boolean

Alias
UMLS CUI [1]
C0021641
UMLS CUI [2]
C0726398
UMLS CUI [3]
C0011854
history of diabetic ketoacidosis.
Description

Diabetic Ketoacidosis

Data type

boolean

Alias
UMLS CUI [1]
C0011880
current infection; surgery or corticosteroid treatment in the last 3 months or antibiotics in the last 3 weeks.
Description

Communicable Diseases | Operative Surgical Procedures | Adrenal Cortex Hormones | Antibiotics

Data type

boolean

Alias
UMLS CUI [1]
C0009450
UMLS CUI [2]
C0543467
UMLS CUI [3]
C0001617
UMLS CUI [4]
C0003232
active malignancy
Description

Malignant Neoplasms

Data type

boolean

Alias
UMLS CUI [1]
C0006826
significant cardiovascular event less than or equal to 6 months prior to screening visit or history of congestive heart failure
Description

Cardiovascular event | Congestive heart failure

Data type

boolean

Alias
UMLS CUI [1]
C1320716
UMLS CUI [2]
C0018802
end state organ failure or status post organ transplant
Description

Organ failure End-stage | Organ Transplantation Status post

Data type

boolean

Alias
UMLS CUI [1,1]
C0349410
UMLS CUI [1,2]
C0205088
UMLS CUI [2,1]
C0029216
UMLS CUI [2,2]
C0231290
history of renal disease
Description

Kidney Diseases

Data type

boolean

Alias
UMLS CUI [1]
C0022658
current hepatic disease
Description

Liver diseases

Data type

boolean

Alias
UMLS CUI [1]
C0023895
history of severe gastroparesis
Description

Gastroparesis Severe

Data type

boolean

Alias
UMLS CUI [1,1]
C0152020
UMLS CUI [1,2]
C0205082
has a chronic, contagious, infectious disease, such as active tuberculosis, hepatitis b or c, or hiv
Description

Chronic infectious disease | Tuberculosis | Hepatitis B | Hepatitis C | HIV Infection

Data type

boolean

Alias
UMLS CUI [1]
C0151317
UMLS CUI [2]
C0041296
UMLS CUI [3]
C0019163
UMLS CUI [4]
C0019196
UMLS CUI [5]
C0019693
currently taking herbals, dietary supplements, or medications, other than anti-hyperglycemic medications, during the past 4 weeks that could profoundly affect blood glucose
Description

Herbal Drugs | Dietary Supplements | Pharmaceutical Preparations Affecting Blood Glucose | Hypoglycemic Agents Excluded

Data type

boolean

Alias
UMLS CUI [1]
C1360419
UMLS CUI [2]
C0242295
UMLS CUI [3,1]
C0013227
UMLS CUI [3,2]
C0392760
UMLS CUI [3,3]
C0005802
UMLS CUI [4,1]
C0020616
UMLS CUI [4,2]
C2828389
clotting or bleeding disorders
Description

Blood Coagulation Disorders

Data type

boolean

Alias
UMLS CUI [1]
C0005779
allergic or intolerant to any ingredient found in the study products
Description

Hypersensitivity Investigational New Drugs Ingredient | Intolerance to Investigational New Drugs Ingredient

Data type

boolean

Alias
UMLS CUI [1,1]
C0020517
UMLS CUI [1,2]
C0013230
UMLS CUI [1,3]
C1550600
UMLS CUI [2,1]
C1744706
UMLS CUI [2,2]
C0013230
UMLS CUI [2,3]
C1550600
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Similar models

Eligibility Type 2 Diabetes NCT00499148

1 forms
Name
Type
Description | Question | Decode (Coded Value)
Data type
Alias
Item Group
C1512693 (UMLS CUI)
Diabetes Mellitus, Non-Insulin-Dependent
Item
type 2 diabetes
boolean
C0011860 (UMLS CUI [1])
Age
Item
between 18 and 75 years of age
boolean
C0001779 (UMLS CUI [1])
Gender | Pregnancy Absent | Breast Feeding Absent | Postpartum Period
Item
male or non-pregnant, non-lactating female, at least 6 weeks postpartum
boolean
C0079399 (UMLS CUI [1])
C0032961 (UMLS CUI [2,1])
C0332197 (UMLS CUI [2,2])
C0006147 (UMLS CUI [3,1])
C0332197 (UMLS CUI [3,2])
C0086839 (UMLS CUI [4])
Childbearing Potential Contraceptive methods
Item
if of childbearing potential, is practicing birth control
boolean
C3831118 (UMLS CUI [1,1])
C0700589 (UMLS CUI [1,2])
Body mass index
Item
bmi is more than or equal to 18kg/m2 and less than or equal to 35kg/m2
boolean
C1305855 (UMLS CUI [1])
Hypoglycemic Agents Dosage Constant | Antihypertensive Agents Dosage Constant | Antilipemic agent Dosage Constant | Thyroid preparations Dosage Constant | Hormone Therapy Dosage Constant
Item
if on anti-hyperglycemic, anti-hypertensive, lipid-lowering, or thyroid medications or hormone therapy, has been on constant dosage for at least 3 months prior to screening visit
boolean
C0020616 (UMLS CUI [1,1])
C0178602 (UMLS CUI [1,2])
C1948059 (UMLS CUI [1,3])
C0003364 (UMLS CUI [2,1])
C0178602 (UMLS CUI [2,2])
C1948059 (UMLS CUI [2,3])
C0086440 (UMLS CUI [3,1])
C0178602 (UMLS CUI [3,2])
C1948059 (UMLS CUI [3,3])
C0279175 (UMLS CUI [4,1])
C0178602 (UMLS CUI [4,2])
C1948059 (UMLS CUI [4,3])
C0279025 (UMLS CUI [5,1])
C0178602 (UMLS CUI [5,2])
C1948059 (UMLS CUI [5,3])
Item Group
C0680251 (UMLS CUI)
Insulin | Glucose control | Diabetes Mellitus, Insulin-Dependent
Item
uses insulin for glucose control or has type 1 diabetes
boolean
C0021641 (UMLS CUI [1])
C0726398 (UMLS CUI [2])
C0011854 (UMLS CUI [3])
Diabetic Ketoacidosis
Item
history of diabetic ketoacidosis.
boolean
C0011880 (UMLS CUI [1])
Communicable Diseases | Operative Surgical Procedures | Adrenal Cortex Hormones | Antibiotics
Item
current infection; surgery or corticosteroid treatment in the last 3 months or antibiotics in the last 3 weeks.
boolean
C0009450 (UMLS CUI [1])
C0543467 (UMLS CUI [2])
C0001617 (UMLS CUI [3])
C0003232 (UMLS CUI [4])
Malignant Neoplasms
Item
active malignancy
boolean
C0006826 (UMLS CUI [1])
Cardiovascular event | Congestive heart failure
Item
significant cardiovascular event less than or equal to 6 months prior to screening visit or history of congestive heart failure
boolean
C1320716 (UMLS CUI [1])
C0018802 (UMLS CUI [2])
Organ failure End-stage | Organ Transplantation Status post
Item
end state organ failure or status post organ transplant
boolean
C0349410 (UMLS CUI [1,1])
C0205088 (UMLS CUI [1,2])
C0029216 (UMLS CUI [2,1])
C0231290 (UMLS CUI [2,2])
Kidney Diseases
Item
history of renal disease
boolean
C0022658 (UMLS CUI [1])
Liver diseases
Item
current hepatic disease
boolean
C0023895 (UMLS CUI [1])
Gastroparesis Severe
Item
history of severe gastroparesis
boolean
C0152020 (UMLS CUI [1,1])
C0205082 (UMLS CUI [1,2])
Chronic infectious disease | Tuberculosis | Hepatitis B | Hepatitis C | HIV Infection
Item
has a chronic, contagious, infectious disease, such as active tuberculosis, hepatitis b or c, or hiv
boolean
C0151317 (UMLS CUI [1])
C0041296 (UMLS CUI [2])
C0019163 (UMLS CUI [3])
C0019196 (UMLS CUI [4])
C0019693 (UMLS CUI [5])
Herbal Drugs | Dietary Supplements | Pharmaceutical Preparations Affecting Blood Glucose | Hypoglycemic Agents Excluded
Item
currently taking herbals, dietary supplements, or medications, other than anti-hyperglycemic medications, during the past 4 weeks that could profoundly affect blood glucose
boolean
C1360419 (UMLS CUI [1])
C0242295 (UMLS CUI [2])
C0013227 (UMLS CUI [3,1])
C0392760 (UMLS CUI [3,2])
C0005802 (UMLS CUI [3,3])
C0020616 (UMLS CUI [4,1])
C2828389 (UMLS CUI [4,2])
Blood Coagulation Disorders
Item
clotting or bleeding disorders
boolean
C0005779 (UMLS CUI [1])
Hypersensitivity Investigational New Drugs Ingredient | Intolerance to Investigational New Drugs Ingredient
Item
allergic or intolerant to any ingredient found in the study products
boolean
C0020517 (UMLS CUI [1,1])
C0013230 (UMLS CUI [1,2])
C1550600 (UMLS CUI [1,3])
C1744706 (UMLS CUI [2,1])
C0013230 (UMLS CUI [2,2])
C1550600 (UMLS CUI [2,3])
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