|
Signed the informed consent | Screening
|
|
Inclusion and Exclusion criteria | Screening
|
|
General information, History of disease | Screening
|
|
Physical examination， TCM syndrome | Enrollment
/Baseline
/The 4th week of the treatment
/The 8th week of the treatment
/Completed
|
|
HbA1c, 24h urinary microalbumin | Screening
/Baseline
/Completed
|
|
Fasting blood glucose, Blood fat, Blood routine tests, Urine routine tests, Liver function tests, Renel function tests | Baseline
/The 4th week of treatment
/Completed
|
|
Serum FFA tests， ECG | Baseline
/Completed
|
|
Check for allocation of the madicine | Baseline
/The 4th week of treatment
/The 8th week of treatment
|
|
Effect assessmen | The 4th week of the treatment
/The 8th week of the treatment
/Completed
|
|
Eligible participant has to fullfill all of the following items | / / / / / / |
|
Anyone with one of following items or more should be excluded: |
- General Information
- History of present illness
- History of disease
- Family history of diabetes
- History of drug allergy
- Physical Examination
- Fasting Blood Glucose
- HbA1c
- blood Fat
- Quantitative test of 24h urinary protein
- Blood Routine Tests
- Urine Routine Tests
- Liver Function Tests
- Renel Function Tests
- Electrocardiogram
- Serum FFA tests
- TCM syndrome scores
- History of diabetes drug therapy
- Combined medication for other diseases
- Treatment of the studyed drugs
|
Date of birth | 1966-08-29 yyyy-mm-dd |
|
Age | 50 Years |
|
Diabetes | |
|
Type of Diabetes | Type II
|
|
Duration of the diabetes | 0.5 年 |
|
Diabetic Kidney Disease | |
|
Diagnosed to be diabetic kidney disease | 2016-07-24 yyyy-mm-dd |
|
Duration of the diabetic kidney disease | 0 年 |
|
Medication therapy or not | No
|
|
Disease name |
|
|
Does it keep to continue | |
|
Date of starting | yyyy-mm-dd |
|
Ending time | yyyy-mm-dd |
|
Disease name |
|
|
Does it continue to now | |
|
Date of starting | yyyy-mm-dd |
|
Ending time | yyyy-mm-dd |
|
Disease name |
|
|
Does it contimue to now | |
|
Date of starting | yyyy-mm-dd |
|
Ending time | yyyy-mm-dd |
|
Disease name |
|
|
Does it continue | |
|
Date of starting | yyyy-mm-dd |
|
Ending time | yyyy-mm-dd |
|
Researcher signature | 秦鑫 |
|
Date | 2016-07-23 yyyy-mm-dd |
|
Is/was there anyone with diabetes in your family? | No
|
|
Did you experienced any drug allergy? | No
|
|
Namy of the drug to be allergied |
|
|
Date of drug allergy happened | yyyy-mm-dd/mm-dd |
|
Current status |
|
|
Systolic pressure (SP) | 120 mmHg |
|
Diastolic pressure | 75 mmHg |
|
Temperature | 36.5 degree Celsius |
|
Pulse | 68 次/分 |
|
Breath | 16 次/分 |
|
Fasting blood glucos concentration | 5.6 mmol/L |
|
Date of test | 2016-07-26 yyyy-mm-dd |
|
HbA1c | 5.7 % |
|
Date of test | 2016-07-24 yyyy-mm-dd |
|
Triglycerides | 1.27 mmol/L |
|
Total cholesterol | 4.17 mmol/L |
|
High density lipoprotein cholesterol | 1.02 mmol/L |
|
Low density lipoprotein cholesterol | 2.63 mmol/L |
|
Date of examination | 2016-07-26 yyyy-mm-dd |
|
24h urinary albumin | 264.6 mg/24h |
|
24h urinary microalbumin | 30.1 mg/24h |
|
Hb | 129.0 g/L |
|
RBC | 4.67 X10*12/L |
|
WBC | 6.07 X10*9/L |
|
PLT | 313.0 X10*9/L |
57.0 % |
|
37.1 % |
|
|
Date of test | 2016-07-26 |
|
Urine protein | Negative
|
|
Urine red cell | Suspending
|
|
Urine WBC | Negative
|
|
Urine glucos | Negative
|
|
KET | Negative
|
|
SG | 1.027 |
|
Date of test | 2016-07-26 yyyy-mm-dd |
|
ALT | 9 IU/L |
|
AST | 14 IU/L |
|
Serum albumin | 47.6 g/L |
|
Date of test | 2016-07-26 yyyy-mm-dd |
|
Blood urea | 5.00 mmol/L |
|
SCr | 54 μmol/L |
|
Blood uric acid | 190.0 μmol/L |
|
eGFR | 103.7 ml/min/1.73m2 |
|
Date of test | 2016-07-26 yyyy-mm-dd |
|
ECG | Normal
|
|
Description for the abnormal findings |
|
|
Date of examination | 2016-07-26 yyyy-mm-dd |
|
Serum FFA tests | 未测 |
|
Soreness and weakness of waist and knees | Moderate soreness and weakness of waist and knees
|
|
Lack of sexuality | |
|
Intolerance of cold and cold limbs | Slight intolerance of cold
|
|
Mental sluggishness | General
|
|
Frequent urination at night | Twice
|
|
Lower Limb Edema | No
|
|
Shortness of breath when moving | Shortness of breath when climbing stairs
|
|
Alopecia and shaken teeth | Dry hair and shaken teeth
|
|
Tongue characteristics | Light white
|
|
Tongue coating colour and characters | White tongue coating with water
|
|
Pause profile | Deep, thin, slow
|
|
Description in detail | 无 |
|
Doctor signature | 秦鑫 |
|
Date | 2016-07-26 yyyy-mm-dd |
|
Insulin | No
|
|
Dose | IU |
|
Date of using | yyyy-mm-dd |
|
Metformin drugs | No
|
|
Name of drug |
|
|
Dose | mg |
|
Date of use the drug | yyyy-mm-dd |
|
Sulfonylureas | No
|
|
Name of the drug |
|
|
Dose | mg |
|
Other reduce surgur drugs | Yes
|
|
Name of drug | 拜糖平 |
|
Dose | 0.2mg，tid |
|
Was there any combination use drug? | No
|
|
Name of the drug |
|
|
Approch of using the drug |
|
|
Date of starting use | yyyy-mm-dd |
|
Date of completed using | yyyy-mm-dd |
|
Reason of using |
|
|
Name of the drug |
|
|
Approch of using the drug |
|
|
Date of starting use | yyyy-mm-dd |
|
Date of completed using | yyyy-mm-dd |
|
Reason of using |
|
|
Number | 003 |
|
Dose | 1 袋/次 |
|
Frequency | 2 次/天 |
无 |
- TCM syndrome
- Fasting Blood Glucose
- blood lipids
- Blood Routine Tests
- Urine Routine Tests
- Liver Function Tests
- Renel Function Tests
- Treatment of studyed drugs
- Adverse events
|
Soreness and weakness of waist and knees | Moderate soreness and weakness of waist and knees
|
|
Lack of sexuality | No
|
|
Intolerance of cold and cold limbs | Slight intolerance of cold
|
|
Mental sluggishness | No
|
|
Frequent urination at night | Three times at night
|
|
Lower Limbs Edema | No
|
|
Shortness of breath when moving | Shortness of breath when walking
|
|
Alopecia and shaken teeth | Dry hair and shaken teeth
|
|
Tongue characteristics | Light white
|
|
Tongue coating colour and characters | White tongue coating with water
|
|
Pause profile | Deep, thin, slow
|
|
Description in detail | 无 |
|
Doctor signature | 秦鑫 |
|
Date | 2016-08-20 yyyy-mm-dd |
|
Systolic pressure (SP) | 122 mmHg |
|
Diastolic pressure | 76 mmHg |
|
Temperature | 36.8 degree Celsius |
|
Pulse | 72 次/分 |
|
Breath | 17 次/分 |
|
Doctor signature | 秦鑫 |
|
Date | 2016-08-20 yyyy-mm-dd |
|
Fasting blood glucose | 5.43 mmol/L |
|
Date of test | 2016-08-20 yyyy-mm-dd |
|
Triglycerides | 0.57 mmol/L |
|
Total cholesterol | 3.42 mmol/L |
|
High density lipoprotein cholesterol | 0.96 mmol/L |
|
Low density lipoprotein cholesterol | 2.15 mmol/L |
|
Date of examination | 2016-08-20 yyyy-mm-dd |
|
Hb | 128.0 g/L |
|
RBC | 4.70 X10*12/L |
|
WBC | 6.97 X10*9/L |
|
PLT | 312.0 X10*9/L |
|
Neutrophile granulocyte | 62.4 % |
|
Lymphocyte | 30。0 % |
|
Date of test | 2016-08-20 |
|
Urine protein | Positive
|
|
Urine red cell | Suspending
|
|
Urine WBC | Negative
|
|
Urine glucos | Negative
|
|
KET | Negative
|
|
SG | 1.027 |
|
Date of test | 2016-08-20 yyyy-mm-dd |
|
ALT | 11 IU/L |
|
AST | 14 IU/L |
|
Serum albumin | 45.9 g/L |
|
Date of test | 2016-08-20 yyyy-mm-dd |
|
Blood urea | 5.33 mmol/L |
|
SCr | 55 μmol/L |
|
Blood uric acid | 191.6 μmol/L |
|
Estimated glomerular filtration rate ( eGFR) | 101.5 ml/min/1.73m*2 |
|
Date of test | 2016-08-20 yyyy-mm-dd |
|
Date of using the drug | 2016-07-26 yyyy-mm-dd |
|
Dose in total | 2 袋/天 |
|
Weeks of medication | 4 周 |
|
Adverse events | No
|
|
Name of adverse event |
|
|
Reason of adverse event |
|
|
Start date | yyyymmdd |
|
Interventions | |
|
Attribution to study drug | |
|
Outcome of the event | |
|
If recovered/resolved, the date is | yyyymmdd |
|
Site Investigator’s signature | 秦鑫 |
|
Data | 2016-07-26 yyyymmdd |
|
Name of adverse event |
|
|
Reason of adverse event |
|
|
Start date | yyyymmdd |
|
Interventions | |
|
Attribution to study drug | |
|
Outcome of the event | |
|
If recovered/resolved, the date is | yyyymmdd |
|
Site Investigator’s signature | 秦鑫 |
|
Data | 2016-07-26 yyyymmdd |
|
Severe Adverse Event | |
|
Type of the report | |
|
Date of report | yyyy-mm-dd-hh-min. |
|
Name of the event |
|
|
SAE situation | |
|
Time of the adverse event occur | yyyy-mm-dd-hh-min. |
|
Severity of SAE | |
|
Measure for the original treatment | |
|
Outcome of the SAE | |
|
Relationship between treatment and SAE | |
|
Treatment in detail |
|
|
Reporting person |
|
|
Doctor signature | 秦鑫 |
|
Date | 2016-08-20 yyy-mm-dd |
|
Soreness and weakness of waist and knees | Slight soreness and weakness of waist and knees
|
|
Lack of sexuality | No
|
|
Intolerance of cold and cold limbs | Slight intolerance of cold
|
|
Mental sluggishness | No
|
|
Frequent urination at night | Three times at night
|
|
Lower Limbs Edema | Slight Lower Limbs Edema
|
|
Shortness of breath when moving | No
|
|
Alopecia and shaken teeth | Dry hair and shaken teeth
|
|
Tongue characteristics | Light red
/Other types
|
|
Tongue coating colour and characters | White tongue coating with water
|
|
Pause profile | Deep, thin and slow
|
|
Description in detail | 无 |
|
Doctor signature | 秦鑫 |
|
Date | 2016-09-20 yyyy-mm-dd |
|
Systolic pressure (SP) | 125 mmHg |
|
Diastolic pressure | 76 mmHg |
|
Temperature | 37.0 degree Celsius |
|
Pulse | 78 次/分 |
|
Breath | 18 次/分 |
|
Doctor signature | 秦鑫 |
|
Date | 2016-09-20 yyyy-mm-dd |
|
Date of using the drug | 2016-07-26 yyyy-mm-dd |
|
Dose in total | 2 袋/天 |
|
Weeks of medication | 8 周 |
|
Adverse events | No
|
|
Name of adverse event |
|
|
Reason of adverse event |
|
|
Start date | yyyymmdd |
|
Interventions | |
|
Attribution to study drug | |
|
Outcome of the event | |
|
If recovered/resolved, the date is | yyyymmdd |
|
Site Investigator’s signature | 秦鑫 |
|
Data | 2016-07-26 yyyymmdd |
|
Name of adverse event |
|
|
Reason of adverse event |
|
|
Start date | yyyymmdd |
|
Interventions | |
|
Attribution to study drug | |
|
Outcome of the event | |
|
If recovered/resolved, the date is | yyyymmdd |
|
Site Investigator’s signature | 秦鑫 |
|
Data | 2016-07-26 yyyymmdd |
|
Date received at DCC | yyyymmdd |
|
Report type | |
|
Name of this event |
|
|
SAE start date | yyyymmdd |
|
SAE stop date | yyyymmdd |
|
Was this an unanticipated adverse event | |
|
Attribution to Study Drug | |
|
Outcome Type(check all that apply) | |
|
Recovery Description: (check only one) | |
|
Please provide a brief narrative of the SAE occurrence below |
|
|
Name of the recorder |
|
|
Data | yyyymmdd |
|
Site Investigator’s signature | 秦鑫 |
|
Data | 2016-07-26 yyyymmdd |
- TCM syndrome scores
- Physical Examination
- Fasting Blood Glucose
- HbA1c
- Blood lipids
- 24h urinary albumin
- Blood Routine Tests
- Urine Routine Tests
- Liver Function Tests
- Renel Function Tests
- Electrocardiogram
- Serum FFA tests
- Treatment of studyed drugs
- Adverse events
|
Soreness and weakness of waist and knees | No
|
|
Lack of sexuality | No
|
|
Intolerance of cold and cold limbs | No
|
|
Mental sluggishness | No
|
|
Frequent urination at night | Twice at night
|
|
Lower Limbs Edema | No
|
|
Shortness of breath when moving | No
|
|
Alopecia and shaken teeth | Dry hair and shaken teeth
|
|
Tongue characteristics | Light red
/Other types
|
|
Tongue coating colour and characters | Thin and white and wet tongue coating
/Other types
|
|
Pause profile | Flat
/Other types
|
|
Description in detail | 无 |
|
Doctor signature | 秦鑫 |
|
Date | 2016-10-22 yyyy-mm-dd |
|
Systolic pressure (SP) | 115 mmHg |
|
Diastolic pressure | 76 mmHg |
|
Temperature | 36.6 degree Celsius |
|
Pulse | 76 次/分 |
|
Breath | 17 次/分 |
|
Doctor signature | 秦鑫 |
|
Date | 2016-10-22 yyyy-mm-dd |
|
Fasting blood glucos concentration | 4.95 mmol/L |
|
Date of test | 2016-10-22 yyyy-mm-dd |
|
HbA1c | 5.5 % |
|
Date of test | 2016-10-22 yyyy-mm-dd |
|
Triglycerides | 1.25 mmol/L |
|
Total cholesterol | 4.10 mmol/L |
|
High density lipoprotein cholesterol | 1.15 mmol/L |
|
Low density lipoprotein cholesterol | 2.73 mmol/L |
|
Date of examination | 2016-10-22 yyyy-mm-dd |
|
24h urinary albumin | 74.1 mg/24h |
|
24h urinary microalbumin | <3.9 mg/24h |
|
Date of test | 2016-10-22 yyyy-mm-dd |
|
Hb | 117.0 g/L |
|
RBC | 4.19 X10*12/L |
|
WBC | 7.44 X10*9/L |
|
PLT | 302.0 X10*9/L |
|
Neutrophile granulocyte | 72.9 % |
|
Lymphocyte | 20.2 % |
|
Date of test | 2016-10-22 |
|
Urine protein | Negative
|
|
Urine red cell | Positive+++
|
|
Urine WBC | Negative
|
|
Urine glucos | Negative
|
|
KET | Negative
|
|
SG | 1.003 |
|
Date of test | 2016-10-22 yyyy-mm-dd |
|
ALT | 8 IU/L |
|
AST | 10 IU/L |
|
Serum albumin | 45.4 g/L |
|
Date of test | 2016-10-22 yyyy-mm-dd |
|
SCr | 51 μmol/L |
|
Blood urea | 3.95 mmol/L |
|
Blood uric acid | 225.0 μmol/L |
|
Estimated glomerular filtration rate ( eGFR) | 107.3 ml/mim/1.73m*2 |
|
Date of test | 2016-10-22 yyyy-mm-dd |
|
ECG | Normal
|
|
Description for the abnormal findings |
|
|
Date of examination | 2016-10-22 yyyy-mm-dd |
|
Serum FFA tests | 无 |
|
Date of test | 2016-10-22 yyyy-mm-dd |
|
Date of completing the treatment | 2016-10-22 yyyy-mm-dd |
|
Weeks of medication | 12 周 |
|
Adverse events | No
|
|
Name of adverse event |
|
|
Reason of adverse event |
|
|
Start date | yyyymmdd |
|
Interventions | |
|
Attribution to study drug | |
|
Outcome of the event | |
|
If recovered/resolved, the date is | yyyymmdd |
|
Site Investigator’s signature | 秦鑫 |
|
Data | 2016-10-22 yyyymmdd |
|
Name of adverse event |
|
|
Reason of adverse event |
|
|
Start date | yyyymmdd |
|
Interventions | |
|
Attribution to study drug | |
|
Outcome of the event | |
|
If recovered/resolved, the date is | yyyymmdd |
|
Site Investigator’s signature | 秦鑫 |
|
Data | 2016-10-22 yyyymmdd |
|
Date received at DCC | yyyymmdd |
|
Report type | |
|
Name of this event |
|
|
SAE start date | yyyymmdd |
|
Was this an unanticipated adverse event | |
|
Attribution to Study Drug | |
|
Outcome Type(check all that apply) | |
|
Recovery Description: (check only one) | |
|
Please provide a brief narrative of the SAE occurrence below |
|
|
Name of the recorder |
|
|
Data | yyyymmdd |
|
Site Investigator’s signature | 秦鑫 |
|
Data | 2016-10-22 yyyymmdd |
|
The date of the first medication | 2016-07-26 yyyy-mm-dd |
|
Date of the last medication | 2016-10-22 yyyy-mm-dd |
|
Has the participant completed the study per the protocol? | Yes
|
|
Date of suspended the study | yyyy-mm-dd |
|
The reason of the suspending | |
|
Description for the other reason of suspending |
|
|
Has the participant had completed the site visiting? | Yes
|
|
Date of the last visiting | yyyy-mm-dd |
|
Reason of suspending | |
|
Description for other reason of uncomplete the follow-up |
|
|
Clinical Minitor Statement | / / / / / / / / |
|
The Monitor signature | 杨明炜 |
|
Date of signature | 2017-02-18 yyyy-mm-dd |
|
The Responsible Person (PI) Signature | 陆付耳 |
|
Date of signature | 2017-02-18 yyyy-mm-dd |