Efficacy and Safety of Jinshuibao Capsule on Diabetic Kidney Disease
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|ClinicalTrials.gov Identifier: NCT03164785|
Recruitment Status : Recruiting
First Posted : May 24, 2017
Last Update Posted : September 7, 2018
|Condition or disease||Intervention/treatment||Phase|
|Type 2 Diabetes Mellitus Diabetic Kidney Disease||Drug: Jinshuibao Capsule||Phase 2 Phase 3|
|Study Type :||Interventional (Clinical Trial)|
|Estimated Enrollment :||200 participants|
|Intervention Model:||Parallel Assignment|
|Masking:||None (Open Label)|
|Official Title:||Efficacy and Safety of Jinshuibao Capsule as Add-on Therapy to Angiotensin II Receptor Blockers on Diabetic Kidney Disease in Patients With Type 2 Diabetes Mellitus|
|Actual Study Start Date :||November 17, 2017|
|Estimated Primary Completion Date :||December 2018|
|Estimated Study Completion Date :||April 2019|
Experimental: Treatment Group
Treatment：subjects receive Jinshuibao Capsule. ARB will be continued as a routine therapy.
Counseling: subjects will follow through regular check-up and receive lifestyle and other diabetes treatment counseling
Drug: Jinshuibao Capsule
1.98g t.i.d. p.o. for 6 months
No Intervention: Control Group
Patients receive a standard dose of ARB drug as a routine therapy. Counseling: subjects will follow through regular check-up and receive lifestyle and other diabetes treatment counseling
- Change in urine albumin creatine ratio (ACR). [ Time Frame: Baseline and 1,2,3,6 months. ]First morning urine (10-15ml) of the subject is collected with a clean urine collection tube (or vial).
- The incidence of ≧30% decline in eGFR from baseline. [ Time Frame: half a year ]Monitoring changes in glomerular functions measured in estimated glomerular filtration rate (eGFR) [CKD-EPI creatinine-cystatin equation (2012)].
- Change in urine α1-microglobulin. [ Time Frame: Baseline and 1,2,3,6 months. ]
- Change in urine β2-microglobulin. [ Time Frame: Baseline and 1,2,3,6 months. ]
- Change in urine N-acetyl-β-D-glucosidase. [ Time Frame: Baseline and 1,2,3,6 months. ]
- Change in urine neutrophil gelatinase-associated lipocalin. [ Time Frame: Baseline and 1,2,3,6 months. ]
- Change in inflammation level. [ Time Frame: Baseline and 1,2,3,6 months. ]Change in hs-CRP level.
- Change in HbA1c. [ Time Frame: Baseline and 1,3,6 months. ]
- Change in blood pressure control. [ Time Frame: Baseline and 1,2,3,6 months. ]
- Change in blood lipids. [ Time Frame: Baseline and 1,3,6 months. ]
- Life quality evaluation [ Time Frame: Baseline and 6 months. ]Change in SF-36 Scale score.
- Incidence of Treatment-Emergent Adverse Events [ Time Frame: half a year ]Treatment-related adverse events as assessed by deterioration of liver functions with other reasons excluded, self-report of gastrointestinal symptoms associated with drug intake, etc.
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03164785
|Contact: Zhiguang Zhou, MD/PhDfirstname.lastname@example.org|
|The Second Xiangya Hospital of Central South University||Recruiting|
|Changsha, Hunan, China, 410011|
|Contact: Zhou Zhiguang, PhD +8613873104348 email@example.com|
|Contact: Cao Chuqing, MD +8615073136917 firstname.lastname@example.org|
|Principal Investigator: Zhou Zhiguang, PhD|
|Sub-Investigator: Cao Chuqing, MD|
|Sub-Investigator: Yang Shuting, BA|
|Principal Investigator:||Zhiguang Zhou, MD/PhD||Second Xiangya Hospital, Central South University|