Efficacy and Safety of Abelmoschus Manihot for IgA Nephropathy
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|ClinicalTrials.gov Identifier: NCT02231125|
Recruitment Status : Unknown
Verified July 2016 by Chen Xiangmei, Chinese PLA General Hospital.
Recruitment status was: Recruiting
First Posted : September 4, 2014
Last Update Posted : July 6, 2016
|Condition or disease||Intervention/treatment||Phase|
|IgA Nephropathy||Drug: Losartan Drug: Abelmoschus manihot||Phase 4|
|Study Type :||Interventional (Clinical Trial)|
|Estimated Enrollment :||1600 participants|
|Intervention Model:||Parallel Assignment|
|Masking:||Double (Participant, Care Provider)|
|Official Title:||Efficacy and Safety of Abelmoschus Manihot for IgA Nephropathy: a Multicentre, Double-blind, Double-dummy, Randomized Controlled Trial|
|Study Start Date :||September 2014|
|Estimated Primary Completion Date :||July 2016|
|Estimated Study Completion Date :||December 2017|
Experimental: Abelmoschus manihot (AM)
Abelmoschus manihot (AM): Huangkui capsule (Jiangsu Suzhong Pharmaceutical Group Co., Ltd.), 0.5 g × 30 capsules/box. A huangkui capsule is a single plant drug extract of Flos Abelmoschus manihot.
Drug: Abelmoschus manihot
Huangkui Capsule 2.5g/time, thrice /day plus Losartan potassium tablet dummy 100mg/time, once /day, all drug and dummy are taken orally every day for 48 weeks during the whole study process.
Other Name: Huangkui Capsule
Losartan potassium (Hangzhou MSD Pharmaceutical Co., Ltd.), 100 mg × 7 capsules/box.
Losartan potassium tablet 100mg/time, once /day plus Huangkui Capsule dummy 2.5g/time, thrice /day, all drug and dummy are taken orally every day for 48 weeks during the whole study process.
Other Name: Cozaar
- Change in 24-h proteinuria from baseline after treatment [ Time Frame: Baseline(week 0), week 4, week 12, week 24, week 36, week 48 ]
- Change in serum creatinine from baseline after treatment [ Time Frame: Baseline(week 0), week 4, week 12, week 24, week 36, week 48 ]
- Change in estimated glomerular filtration rate (eGFR) from baseline after treatment [ Time Frame: Baseline(week 0), week 4, week 12, week 24, week 36, week 48 ]
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): NCT02231125
|Contact: Xiangmei Chen, MD.&Ph.Dfirstname.lastname@example.org|
|Contact: Xuefeng Sun, MD.&Ph.Demail@example.com|
Show 88 Study Locations
|Principal Investigator:||Xiangmei Chen, MD.& Ph.D||Department of Nephrology,State Key Laboratory of Kidney Disease,National Clinical Research Center for Kidney Disease, Chinese PLA General Hospital|