|
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 | 1967-01-07 yyyy-mm-dd |
|
Age | 49 Years |
|
Diabetes | |
|
Type of Diabetes | Type II
|
|
Duration of the diabetes | 13 年 |
|
Diabetic Kidney Disease | |
|
Diagnosed to be diabetic kidney disease | 2016-07-22 yyyy-mm-dd |
|
Duration of the diabetic kidney disease | 0 年 |
|
Medication therapy or not | No
|
|
Disease name | 高血压病 |
|
Does it keep to continue | Yes
|
|
Date of starting | 2006 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 | 2016-07-22 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) | 125 mmHg |
|
Diastolic pressure | 75 mmHg |
|
Temperature | 37 degree Celsius |
|
Pulse | 72 次/分 |
|
Breath | 18 次/分 |
|
Fasting blood glucos concentration | 5.78 mmol/L |
|
Date of test | 2016-07-23 yyyy-mm-dd |
|
HbA1c | 6.5 % |
|
Date of test | 2016-07-23 yyyy-mm-dd |
|
Triglycerides | 0.76 mmol/L |
|
Total cholesterol | 4.30 mmol/L |
|
High density lipoprotein cholesterol | 1.43 mmol/L |
|
Low density lipoprotein cholesterol | 2.58 mmol/L |
|
Date of examination | 2016-07-23 yyyy-mm-dd |
|
24h urinary albumin | 154 mg/24h |
|
24h urinary microalbumin | 20.9 mg/24h |
|
Hb | 129.0 g/L |
|
RBC | 4.23 X10*12/L |
|
WBC | 4.73 X10*9/L |
|
PLT | 204.0 X10*9/L |
41.1 % |
|
47.1 % |
|
|
Date of test | 2016-07-23 |
|
Urine protein | Negative
|
|
Urine red cell | Positive++
|
|
Urine WBC | Positive+
|
|
Urine glucos | Suspending
|
|
KET | Negative
|
|
SG | 1.030 |
|
Date of test | 2016-07-23 yyyy-mm-dd |
|
ALT | 20 IU/L |
|
AST | 20 IU/L |
|
Serum albumin | 45.1 g/L |
|
Date of test | 2016-07-23 yyyy-mm-dd |
|
Blood urea | 7.30 mmol/L |
|
SCr | 57 μmol/L |
|
Blood uric acid | 222.0 μmol/L |
|
eGFR | 97.8 ml/min/1.73m2 |
|
Date of test | 2016-07-23 yyyy-mm-dd |
|
ECG | Normal
|
|
Description for the abnormal findings |
|
|
Date of examination | 2016-07-23 yyyy-mm-dd |
|
Serum FFA tests |
|
|
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 | No
|
|
Mental sluggishness | No
|
|
Frequent urination at night | Four times or more frequent
|
|
Lower Limb Edema | Moderate Lower Limb Edema
|
|
Shortness of breath when moving | Shortness of breath when climbing stairs
|
|
Alopecia and shaken teeth | No
|
|
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 | 2016-07-23 yyyy-mm-dd |
|
Insulin | No
|
|
Dose | IU |
|
Date of using | yyyy-mm-dd |
|
Metformin drugs | Yes
|
|
Name of drug | 格华止 |
|
Dose | 250 mg |
|
Date of use the drug | 2013-02-15 yyyy-mm-dd |
|
Sulfonylureas | Yes
|
|
Name of the drug | 伏格列波糖 |
|
Dose | 0.2 mg |
|
Other reduce surgur drugs | No
|
|
Name of drug |
|
|
Dose |
|
|
Was there any combination use drug? | Yes
|
|
Name of the drug | 美卡素（替米沙坦片） |
|
Approch of using the drug | 40mg，qd |
|
Date of starting use | 2006-01-01 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 | No
|
|
Mental sluggishness | General
|
|
Frequent urination at night | Four times at night or more frequent
|
|
Lower Limbs Edema | Moderate Slight Lower Limbs Edema
|
|
Shortness of breath when moving | Shortness of breath when climbing stairs
|
|
Alopecia and shaken teeth | No
|
|
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) | 128 mmHg |
|
Diastolic pressure | 80 mmHg |
|
Temperature | 36.5 degree Celsius |
|
Pulse | 80 次/分 |
|
Breath | 16 次/分 |
|
Doctor signature | 秦鑫 |
|
Date | 2016-08-20 yyyy-mm-dd |
|
Fasting blood glucose | 6,71 mmol/L |
|
Date of test | 2016-08-20 yyyy-mm-dd |
|
Triglycerides | 0.62 mmol/L |
|
Total cholesterol | 4.07 mmol/L |
|
High density lipoprotein cholesterol | 1.41 mmol/L |
|
Low density lipoprotein cholesterol | 2.34 mmol/L |
|
Date of examination | 2016-08-20 yyyy-mm-dd |
|
Hb | 128.0 g/L |
|
RBC | 4.16 X10*12/L |
|
WBC | 5.09 X10*9/L |
|
PLT | 196.0 X10*9/L |
|
Neutrophile granulocyte | 52.8 % |
|
Lymphocyte | 38.7 % |
|
Date of test | 2016-08-20 |
|
Urine protein | Negative
|
|
Urine red cell | Positive++
|
|
Urine WBC | Suspending
|
|
Urine glucos | Negative
|
|
KET | Negative
|
|
SG | 1.026 |
|
Date of test | 2016-08-20 yyyy-mm-dd |
|
ALT | 24 IU/L |
|
AST | 20 IU/L |
|
Serum albumin | 47.2 g/L |
|
Date of test | 2016-08-20 yyyy-mm-dd |
|
Blood urea | 8.24 mmol/L |
|
SCr | 57 μmol/L |
|
Blood uric acid | 174.1 μmol/L |
|
Estimated glomerular filtration rate ( eGFR) | 97.8 ml/min/1.73m*2 |
|
Date of test | 2016-08-20 yyyy-mm-dd |
|
Date of using the drug | 2016-07-23 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 | 2016-07-23 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 | 2016-07-23 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 | No
|
|
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 | No
|
|
Tongue characteristics | Light red
/Other types
|
|
Tongue coating colour and characters | White tongue coating with water
|
|
Pause profile | Flat
/Other types
|
|
Description in detail | 无 |
|
Doctor signature | 秦鑫 |
|
Date | 2016-09-20 yyyy-mm-dd |
|
Systolic pressure (SP) | 130 mmHg |
|
Diastolic pressure | 82 mmHg |
|
Temperature | 37.1 degree Celsius |
|
Pulse | 68 次/分 |
|
Breath | 19 次/分 |
|
Doctor signature | 秦鑫 |
|
Date | 2016-09-20 yyyy-mm-dd |
|
Date of using the drug | 2016-07-23 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 |
|
|
Data | 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 |
|
|
Data | 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 | 2016-09-20 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 | 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 | Twice at night
|
|
Lower Limbs Edema | Moderate Lower Limbs Edema
|
|
Shortness of breath when moving | No
|
|
Alopecia and shaken teeth | No
|
|
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 | 2016-10-23 yyyy-mm-dd |
|
Systolic pressure (SP) | 120 mmHg |
|
Diastolic pressure | 75 mmHg |
|
Temperature | 36.8 degree Celsius |
|
Pulse | 70 次/分 |
|
Breath | 17 次/分 |
|
Doctor signature | 秦鑫 |
|
Date | 2016-10-23 yyyy-mm-dd |
|
Fasting blood glucos concentration | 6.22 mmol/L |
|
Date of test | 2016-10-23 yyyy-mm-dd |
|
HbA1c | 6.5 % |
|
Date of test | 2016-10-23 yyyy-mm-dd |
|
Triglycerides | 0.89 mmol/L |
|
Total cholesterol | 4.28 mmol/L |
|
High density lipoprotein cholesterol | 1.47 mmol/L |
|
Low density lipoprotein cholesterol | 2.65 mmol/L |
|
Date of examination | 2016-10-23 yyyy-mm-dd |
|
24h urinary albumin | 71 mg/24h |
|
24h urinary microalbumin | <3 mg/24h |
|
Date of test | 2016-10-23 yyyy-mm-dd |
|
Hb | 133.0 g/L |
|
RBC | 4.32 X10*12/L |
|
WBC | 4.65 X10*9/L |
|
PLT | 237.0 X10*9/L |
|
Neutrophile granulocyte | 41.1 % |
|
Lymphocyte | 40.2 % |
|
Date of test | 2016-10-23 |
|
Urine protein | Negative
|
|
Urine red cell | Suspending
|
|
Urine WBC | Negative
|
|
Urine glucos | Negative
|
|
KET | Negative
|
|
SG | 1.008 |
|
Date of test | 2016-10-23 yyyy-mm-dd |
|
ALT | 36 IU/L |
|
AST | 22 IU/L |
|
Serum albumin | 45.6 g/L |
|
Date of test | 2016-10-23 yyyy-mm-dd |
|
SCr | 48 μmol/L |
|
Blood urea | 6.33 mmol/L |
|
Blood uric acid | 174.0 μmol/L |
|
Estimated glomerular filtration rate ( eGFR) | 111.0 ml/mim/1.73m*2 |
|
Date of test | 2016-10-23 yyyy-mm-dd |
|
ECG | Normal
|
|
Description for the abnormal findings |
|
|
Date of examination | 2016-10-23 yyyy-mm-dd |
|
Serum FFA tests | 无 |
|
Date of test | 2016-10-23 yyyy-mm-dd |
|
Date of completing the treatment | 2016-10-23 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 | 2016-10-23 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 | 2016-10-23 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 | 2016-10-23 yyyymmdd |
|
The date of the first medication | 2016-07-23 yyyy-mm-dd |
|
Date of the last medication | 2016-10-23 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 |