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This study will evaluate the efficacy and Safety of QiShen YiQi Dripping Pills in the treatment of Diabetic Kidney Disease (syndrome of Qi deficiency with blood stasis)
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Placebo group | Placebo Comparator | Qishen Yiqi Dripping Pills placebo, 3 bags, take orally after meals, 3 times a day |
|
| Low dose group | Experimental | Low dose Qishen Yiqi Dripping Pills, 3 bags, take orally after meals, 3 times a day |
|
| High dose group | Experimental | High dose Qishen Yiqi Dripping Pills, 3 bags, take orally after meals, 3 times a day |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Qishen Yiqi Dripping Pills placebo 3 bags | Drug | Qishen Yiqi Dripping Pills placebo contain Qishen Yiqi dripping pills placebo 3 bags(0.52g dripping pills placebo per bag),take orally after meals, 3 times a day for 12weeks |
| Measure | Description | Time Frame |
|---|---|---|
| Change in UACR(urinary albumin ⁃ to ⁃ creatinine ratio). | Change in UACR from baseline to weeks 4, 8 and 12. | Baseline to weeks 4, 8 and 12 |
| Measure | Description | Time Frame |
|---|---|---|
| Ratio of subjects with UACR returned to normal. | Ratio of subjects with UACR returned to normal at weeks 4, 8 and 12. | Baseline to weeks 4, 8 and 12 |
| Ratio of subjects with UACR decrease of more than 30% from baseline. |
| Measure | Description | Time Frame |
|---|---|---|
| Change in β2-MG. | Change in β2-MG from baseline to weeks 4, 8 and 12. | Baseline to weeks 4, 8 and 12 |
| Change in Cys-C. | Change in Cys-C from baseline to weeks 4, 8 and 12. |
Inclusion Criteria:
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Rui Liu | Contact | 022-86343626 | liurui2@tasly.com |
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Dongzhimen Hospital of Beijing University of Chinese Medicine | Recruiting | Beijing | Beijing Municipality | China |
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|
| Low dose Qishen Yiqi Dripping Pills 3 bags | Drug | Low dose Qishen Yiqi Dripping Pills contain Qishen Yiqi dripping pills 2 bags(0.52g dripping pills per bag) and Qishen Yiqi dripping pills placebo 1 bag(0.52g dripping pills placebo per bag),take orally after meals, 3 times a day for 12weeks |
|
|
| High dose Qishen Yiqi Dripping Pills 3 bags | Drug | High dose Qishen Yiqi Dripping Pills contain Qishen Yiqi dripping pills 3 bags(0.52g dripping pills per bag),take orally after meals, 3 times a day for 12weeks |
|
|
Ratio of subjects with UACR decrease of more than 30% from baseline at weeks 4, 8 and 12.
| Baseline to weeks 4, 8 and 12 |
| Ratio of subjects from microalbuminuria stage to macroalbuminuria | Ratio of subjects from microalbuminuria stage to macroalbuminuria at weeks 4, 8 and 12. | Baseline to weeks 4, 8 and 12 |
| Change in eGFR(estimated glomerular filtration rate). | Change in eGFR from baseline to weeks 4, 8 and 12. | Baseline to weeks 4, 8 and 12 |
| Change in Traditional Chinese Medicine Syndrome Score | Change in Traditional Chinese Medicine Syndrome Score from baseline to weeks 4, 8 and 12. There were 9 clinical primary symptoms, 7 clinical secondary symptoms, tongue picture and pulse condition evaluated as TCM symptoms, which was defined as TCM syndrome score. The standard of TCM primary symptoms and secondary symptoms scored as without 0, light 2, medium 4, heavy 6 points. Tongue picture and pulse condition did not count. | Baseline to weeks 4, 8 and 12 |
| TCM syndrome | Number and ratio of subjects with Clinical recovery, obvious effect, effective or ineffective in curative effect of TCM syndrome at weeks 4, 8 and 12. | Baseline to weeks 4, 8 and 12 |
| Baseline to weeks 4, 8 and 12 |
| Change in PCX. | Change in PCX from baseline to week 12. | Baseline to week 12 |
| Change in MCP-1. | Change in MCP-1 from baseline to week 12. | Baseline to week 12 |
| Xiyuan Hospital of China Academy of Chinese Medical Sciences | Recruiting | Beijing | Beijing Municipality | China |
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| The Affiliated TCM Hospital of Guangzhou Medical University | Recruiting | Guangzhou | Guangdong | China |
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| Hebei Province Hospital of Traditional Chinese Medicine | Recruiting | Shijiazhuang | Hebei | China |
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| Heilongjiang Academy of Traditional Chinese Medicine (Heilongjiang Provincial Hospital of Traditional Chinese Medicine) | Recruiting | Harbin | Heilongjiang | China |
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| Kaifeng Hospital of Traditional Chinese Medicine | Recruiting | Kaifeng | Henan | China |
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| Luoyang Third People's Hospital | Recruiting | Luoyang | Henan | China |
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| Sanmenxia Central Hospital | Recruiting | Sanmenxia | Henan | China |
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| The First Hospital of Hunan University of Chinese Medicine | Recruiting | Changsha | Hunan | China |
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| Shananxi Province Hospital of Traditional Chinese Medicine | Recruiting | Xi'an | Shananxi | China |
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| Longhua Hospital affiliated to Shanghai University of Traditional Chinese Medicine | Recruiting | Shanghai | Shanghai Municipality | China |
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| Shanghai Sixth People's Hospital | Recruiting | Shanghai | Shanghai Municipality | China |
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| West China Hospital of Sichuan University | Recruiting | Chengdu | Sichuan | China |
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| First Teaching Hospital of Tianjin University of Traditional Chinese Medicine | Recruiting | Tianjin | Tianjin Municipality | China |
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| Hangzhou hospital of traditional Chinese medicine | Recruiting | Hangzhou | Zhejiang | China |
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| The Second Affiliated Hospital Zhejiang University School of Medicine | Recruiting | Hangzhou | Zhejiang | China |
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| ID | Term |
|---|---|
| D003928 | Diabetic Nephropathies |
| ID | Term |
|---|---|
| D007674 | Kidney Diseases |
| D014570 | Urologic Diseases |
| D052776 | Female Urogenital Diseases |
| D005261 | Female Urogenital Diseases and Pregnancy Complications |
| D000091642 | Urogenital Diseases |
| D052801 | Male Urogenital Diseases |
| D048909 | Diabetes Complications |
| D003920 | Diabetes Mellitus |
| D004700 | Endocrine System Diseases |
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| ID | Term |
|---|---|
| D044382 | Population Groups |
| ID | Term |
|---|---|
| D003710 | Demography |
| D011154 | Population Characteristics |
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