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)
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
QUADRUPLE
Enrollment
228
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
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 contain Qishen Yiqi dripping pills 3 bags(0.52g dripping pills per bag),take orally after meals, 3 times a day for 12weeks
Dongzhimen Hospital of Beijing University of Chinese Medicine
Beijing, Beijing Municipality, China
RECRUITINGChange in UACR(urinary albumin ⁃ to ⁃ creatinine ratio).
Change in UACR from baseline to weeks 4, 8 and 12.
Time frame: Baseline to weeks 4, 8 and 12
Ratio of subjects with UACR returned to normal.
Ratio of subjects with UACR returned to normal at weeks 4, 8 and 12.
Time frame: Baseline to weeks 4, 8 and 12
Ratio of subjects with UACR decrease of more than 30% from baseline.
Ratio of subjects with UACR decrease of more than 30% from baseline at weeks 4, 8 and 12.
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: Baseline to weeks 4, 8 and 12
TCM syndrome
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Xiyuan Hospital of China Academy of Chinese Medical Sciences
Beijing, Beijing Municipality, China
RECRUITINGThe Affiliated TCM Hospital of Guangzhou Medical University
Guangzhou, Guangdong, China
RECRUITINGHebei Province Hospital of Traditional Chinese Medicine
Shijiazhuang, Hebei, China
RECRUITINGHeilongjiang Academy of Traditional Chinese Medicine (Heilongjiang Provincial Hospital of Traditional Chinese Medicine)
Harbin, Heilongjiang, China
RECRUITINGKaifeng Hospital of Traditional Chinese Medicine
Kaifeng, Henan, China
RECRUITINGLuoyang Third People's Hospital
Luoyang, Henan, China
RECRUITINGSanmenxia Central Hospital
Sanmenxia, Henan, China
RECRUITINGThe First Hospital of Hunan University of Chinese Medicine
Changsha, Hunan, China
RECRUITINGShananxi Province Hospital of Traditional Chinese Medicine
Xi'an, Shananxi, China
RECRUITING...and 6 more locations
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.
Time frame: Baseline to weeks 4, 8 and 12