|
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 | 1956-08-24 yyyy-mm-dd |
|
Age | 61 Years |
|
Diabetes | |
|
Type of Diabetes | Type II
|
|
Duration of the diabetes | 2 年 |
|
Diabetic Kidney Disease | |
|
Diagnosed to be diabetic kidney disease | 201-08-09 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 |
|
|
Date | 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 | 80 mmHg |
|
Temperature | 36.4 degree Celsius |
|
Pulse | 70 次/分 |
|
Breath | 22 次/分 |
|
Fasting blood glucos concentration | 6.59 mmol/L |
|
Date of test | 201-08-09 yyyy-mm-dd |
|
HbA1c | 6.4 % |
|
Date of test | 201-08-09 yyyy-mm-dd |
|
Triglycerides | 3.15 mmol/L |
|
Total cholesterol | 3.13 mmol/L |
|
High density lipoprotein cholesterol | 0.83 mmol/L |
|
Low density lipoprotein cholesterol | 1.14 mmol/L |
|
Date of examination | 201-08-09 yyyy-mm-dd |
|
24h urinary albumin | 204.3 mg/24h |
|
24h urinary microalbumin | 44.5 mg/24h |
|
Hb | 129 g/L |
|
RBC | 4.43 X10*12/L |
|
WBC | 6.68 X10*9/L |
|
PLT | 242 X10*9/L |
52 % |
|
41.2 % |
|
|
Date of test | 201-08-09 |
|
Urine protein | Suspending
|
|
Urine red cell | Negative
|
|
Urine WBC | Suspending
|
|
Urine glucos | Negative
|
|
KET | Negative
|
|
SG | 1.029 |
|
Date of test | 201-08-09 yyyy-mm-dd |
|
ALT | 11 IU/L |
|
AST | 17 IU/L |
|
Serum albumin | 44.9 g/L |
|
Date of test | 201-08-09 yyyy-mm-dd |
|
Blood urea | 5.10 mmol/L |
|
SCr | 59 μmol/L |
|
Blood uric acid | 362.0 μmol/L |
|
eGFR | 95.3 ml/min/1.73m2 |
|
Date of test | 201-08-09 yyyy-mm-dd |
|
ECG | Normal
|
|
Description for the abnormal findings |
|
|
Date of examination | 201-08-09 yyyy-mm-dd |
|
Serum FFA tests | 无 |
|
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
|
|
Lower Limb Edema | No
|
|
Shortness of breath when moving | No
|
|
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 |
|
|
Doctor signature | 秦鑫 |
|
Date | 201-08-09 yyyy-mm-dd |
|
Insulin | Yes
|
|
Dose | 16 IU |
|
Date of using | 2016-10-12 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 | No
|
|
Name of drug |
|
|
Dose |
|
|
Was there any combination use drug? | Yes
|
|
Name of the drug | 施慧达 |
|
Approch of using the drug | 1#，qd |
|
Date of starting use | yyyy-mm-dd |
|
Date of completed using | yyyy-mm-dd |
|
Reason of using | 高血压 |
|
Name of the drug | 辛伐他汀 |
|
Approch of using the drug | 1#，qn |
|
Date of starting use | yyyy-mm-dd |
|
Date of completed using | yyyy-mm-dd |
|
Reason of using | 高血脂 |
|
Number | 016 |
|
Dose | 1 袋/次 |
|
Frequency | 2 次/天 |
|
- 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 | No
|
|
Frequent urination at night | No
|
|
Lower Limbs Edema | No
|
|
Shortness of breath when moving | No
|
|
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 |
|
|
Doctor signature | 秦鑫 |
|
Date | 201-09-24 yyyy-mm-dd |
|
Systolic pressure (SP) | 115 mmHg |
|
Diastolic pressure | 70 mmHg |
|
Temperature | 36.8 degree Celsius |
|
Pulse | 80 次/分 |
|
Breath | 24 次/分 |
|
Doctor signature | 秦鑫 |
|
Date | 2017-09-24 yyyy-mm-dd |
|
Fasting blood glucose | 7.30 mmol/L |
|
Date of test | 2017-09-24 yyyy-mm-dd |
|
Triglycerides | 6.60 mmol/L |
|
Total cholesterol | 5.34 mmol/L |
|
High density lipoprotein cholesterol | 0.90 mmol/L |
|
Low density lipoprotein cholesterol | 1.37 mmol/L |
|
Date of examination | 2017-09-24 yyyy-mm-dd |
|
Hb | 132 g/L |
|
RBC | 4.52 X10*12/L |
|
WBC | 6.32 X10*9/L |
|
PLT | 236 X10*9/L |
|
Neutrophile granulocyte | 50.9 % |
|
Lymphocyte | 43 % |
|
Date of test | 2017-09-24 |
|
Urine protein | Negative
|
|
Urine red cell | Negative
|
|
Urine WBC | Suspending
|
|
Urine glucos | Negative
|
|
KET | Negative
|
|
SG | 1.005 |
|
Date of test | 2017-09-24 yyyy-mm-dd |
|
ALT | 24 IU/L |
|
AST | 17 IU/L |
|
Serum albumin | 45.5 g/L |
|
Date of test | 2017-09-24 yyyy-mm-dd |
|
Blood urea | 4.20 mmol/L |
|
SCr | 51 μmol/L |
|
Blood uric acid | 335 μmol/L |
|
Estimated glomerular filtration rate ( eGFR) | 100 ml/min/1.73m*2 |
|
Date of test | 2017-09-24 yyyy-mm-dd |
|
Date of using the drug | 2017-08-09 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 | 2017-09-24 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 | 2017-09-24 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 | 2017-09-24 yyy-mm-dd |
|
Soreness and weakness of waist and knees | Moderate soreness and weakness of waist and knees
|
|
Lack of sexuality | Hyposexuality
|
|
Intolerance of cold and cold limbs | No
|
|
Mental sluggishness | No
|
|
Frequent urination at night | No
|
|
Lower Limbs Edema | No
|
|
Shortness of breath when moving | No
|
|
Alopecia and shaken teeth | No
|
|
Tongue characteristics | Light white
|
|
Tongue coating colour and characters | White tongue coating with water
|
|
Pause profile | Flat
/Other types
|
|
Description in detail |
|
|
Doctor signature | 秦鑫 |
|
Date | 2017-10-24 yyyy-mm-dd |
|
Systolic pressure (SP) | 120 mmHg |
|
Diastolic pressure | 80 mmHg |
|
Temperature | 36.5 degree Celsius |
|
Pulse | 78 次/分 |
|
Breath | 20 次/分 |
|
Doctor signature | 秦鑫 |
|
Date | 2017-10-24 yyyy-mm-dd |
|
Date of using the drug | 2017-08-09 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 | 2017-10-24 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 | 2017-10-24 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 | 2017-10-24 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 | 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 | Twice 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 | deep, thin, slow
|
|
Description in detail |
|
|
Doctor signature | 秦鑫 |
|
Date | 2017-12-06 yyyy-mm-dd |
|
Systolic pressure (SP) | 120 mmHg |
|
Diastolic pressure | 85 mmHg |
|
Temperature | 36.8 degree Celsius |
|
Pulse | 78 次/分 |
|
Breath | 22 次/分 |
|
Doctor signature | 秦鑫 |
|
Date | 2017-12-06 yyyy-mm-dd |
|
Fasting blood glucos concentration | 5.11 mmol/L |
|
Date of test | 2017-12-06 yyyy-mm-dd |
|
HbA1c | 5.2 % |
|
Date of test | 2017-12-06 yyyy-mm-dd |
|
Triglycerides | 0.50 mmol/L |
|
Total cholesterol | 3.30 mmol/L |
|
High density lipoprotein cholesterol | 1.72 mmol/L |
|
Low density lipoprotein cholesterol | 1.37 mmol/L |
|
Date of examination | 2017-12-06 yyyy-mm-dd |
|
24h urinary albumin | 575.6 mg/24h |
|
24h urinary microalbumin | 127.9 mg/24h |
|
Date of test | 2017-12-06 yyyy-mm-dd |
|
Hb | 132 g/L |
|
RBC | 4.32 X10*12/L |
|
WBC | 6.29 X10*9/L |
|
PLT | 204 X10*9/L |
|
Neutrophile granulocyte | 49.1 % |
|
Lymphocyte | 41.5 % |
|
Date of test | 2017-12-06 |
|
Urine protein | Negative
|
|
Urine red cell | Negative
|
|
Urine WBC | Negative
|
|
Urine glucos | Negative
|
|
KET | Negative
|
|
SG | 1.016 |
|
Date of test | 2017-12-06 yyyy-mm-dd |
|
ALT | 10 IU/L |
|
AST | 18 IU/L |
|
Serum albumin | 48.6 g/L |
|
Date of test | 2017-12-06 yyyy-mm-dd |
|
SCr | 54 μmol/L |
|
Blood urea | 4.45 mmol/L |
|
Blood uric acid | 191 μmol/L |
|
Estimated glomerular filtration rate ( eGFR) | 98.1 ml/mim/1.73m*2 |
|
Date of test | 2017-12-06 yyyy-mm-dd |
|
ECG | Normal
|
|
Description for the abnormal findings |
|
|
Date of examination | 2017-12-06 yyyy-mm-dd |
|
Serum FFA tests | 无 |
|
Date of test | 2017-12-06 yyyy-mm-dd |
|
Date of completing the treatment | 2017-12-06 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 | 2017-12-06 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 | 2017-12-06 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 | 2017-12-06 yyyymmdd |
|
The date of the first medication | 2017-07-30 yyyy-mm-dd |
|
Date of the last medication | 2017-12-06 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? | |
|
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 | 2017-12-06 yyyy-mm-dd |
|
The Responsible Person (PI) Signature | 陆付耳 |
|
Date of signature | 2017-12-06 yyyy-mm-dd |