Efficacy and Safety of Abelmoschus Manihot for IgA Nephropathy
- Registration Number
- NCT02231125
- Lead Sponsor
- Chen Xiangmei
- Brief Summary
-IgA nephropathy is the most common primary glomerular disease in China, Huangkui Capsule is a single medicament of traditional Chinese medicine consists of Abelmoschus manihot and has been widely used to treat kidney disease. The purpose of this study is to evaluate the safety and efficacy of Abelmoschus manihot for treating IgA nephropathy in large scale samples with long time take.
- Detailed Description
The test has not been completed .
Recruitment & Eligibility
- Status
- UNKNOWN
- Sex
- All
- Target Recruitment
- 1600
- Clinical diagnosed as chronic nephritic syndrome
- IgA nephropathy diagnosed by kidney biopsy
- Aged from 18 to 65 years，male or female
- Blood pressure of ≤140/90mmHg
- Estimated Glomerular Filtration Rate (eGFR)≥45ml/min/1.73 m2
- 24-hour proteinuria ranged between 0.5g-3.0g
- Obtaining the signed informed consent from patients
- Secondary IgA nephropathy
- Be allergic to Huangkui Capsule or Losartan potassium tablet
- Taken Huangkui Capsule or ACEI or ARB in last 6 weeks
- Taken the glucocorticoids, immunosuppressants or common threewingnut root and such as drugs with immunosuppressive actions in the last 12 months
- Blood pressure <90/60mmHg
- Serum potassium level > 5.5mmol / L
- Serum albumin level <30g / L
- Lactation, pregnancy or plans pregnancy during the study period
- Unilateral or bilateral renal artery stenosis
- Combined with severe primary diseases of heart, brain, liver and hematopoietic system and so on, or other serious diseases which can affect the patient's life
- Participating in another clinical study in the same period
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description Abelmoschus manihot (AM) Abelmoschus manihot 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. Losartan Losartan Losartan potassium (Hangzhou MSD Pharmaceutical Co., Ltd.), 100 mg × 7 capsules/box.
- Primary Outcome Measures
Name Time Method Change in 24-h proteinuria from baseline after treatment Baseline(week 0), week 4, week 12, week 24, week 36, week 48
- Secondary Outcome Measures
Name Time Method Change in estimated glomerular filtration rate (eGFR) from baseline after treatment Baseline(week 0), week 4, week 12, week 24, week 36, week 48 Change in serum creatinine from baseline after treatment Baseline(week 0), week 4, week 12, week 24, week 36, week 48
Trial Locations
- Locations (88)
Guang An Men Hospital China Academy of Chinese Medical Sciences
🇨🇳Beijing, Beijing, China
Jilin Province People's Hospital
🇨🇳Changchun, Jilin, China
Ningxia Hui Autonomous Region's Hospital
🇨🇳Yinchuan, Ningxia, China
Jining No.1 People's Hospital
🇨🇳Jining, Shandong, China
Chang Hai Hospital of the Second Military Medical University
🇨🇳Shanghai, Shanghai, China
The First Hospital of Anhui Medical University
🇨🇳Hefei, Anhui, China
The Second Hospital of Anhui Medical University
🇨🇳Hefei, Anhui, China
Beijing Chao-yang Hospital
🇨🇳Beijing, Beijing, China
China-Japan Friendship Hospital
🇨🇳Beijing, Beijing, China
Chinese PLA General Hospital
🇨🇳Beijing, Beijing, China
Dong Zhi Men Hospital of Beijing University of Chinese Medicine
🇨🇳Beijing, Beijing, China
PLA Navy General Hospital
🇨🇳Beijing, Beijing, China
The Second Artillery General Hospital Of Chinese People's Liberation Army
🇨🇳Beijing, Beijing, China
Da Ping Hospital Of Third Military Medical University
🇨🇳Chongqing, Chongqing, China
Yongchuan Hospital Of Chongqing Medical University
🇨🇳Chongqing, Chongqing, China
Chinese People's Liberation Army No.180 Hospital
🇨🇳Quanzhou, Fujian, China
Chinese People's Liberation Army No.174 Hospital
🇨🇳Xiamen, Fujian, China
The First Hospital of Lanzhou University
🇨🇳Lanzhou, Gansu, China
The Second Hospital of Lanzhou University
🇨🇳Lanzhou, Gansu, China
421 Hospital of PLA
🇨🇳Guangzhou, Guangdong, China
Guangdong Province Hospital of Traditional Chinese Medicine(TCM)
🇨🇳Guangzhou, Guangdong, China
Affiliated Hospital of Guilin Medical University
🇨🇳Guilin, Guangxi, China
The First Affiliated Hospital of Guangxi Medical University
🇨🇳Nanning, Guangxi, China
The First Affiliated Hospital of Guangxi University of Chinese Medicine
🇨🇳Nanning, Guangxi, China
Affiliated Hospital of Guiyang Medical College
🇨🇳Guiyang, Guizhou, China
The Affiliated Baiyun Hospital of Guizhou Medical University
🇨🇳Guiyang, Guizhou, China
Affiliated Hospital Of Zun Yi Medical College
🇨🇳Zunyi, Guizhou, China
Hainan Medical College Affiliated Hospital
🇨🇳Haikou, Hainan, China
Hainan Provincial Nong Ken Hospital
🇨🇳Haikou, Hainan, China
Affiliated Hospital of Cheng De Medical College
🇨🇳Chengde, Hebei, China
First Hospital of Qinhuangdao
🇨🇳Qinhuangdao, Hebei, China
Hebei Province Hospital of Traditional Chinese Medicine
🇨🇳Shijiazhuang, Hebei, China
TCM Hospital of Shi Jia Zhuang City
🇨🇳Shijiazhuang, Hebei, China
The Second Hospital of Hebei Medical University
🇨🇳Shijiazhuang, Hebei, China
Heilongjiang Provincial Academy of Traditional Chinese Medicine
🇨🇳Haerbin, Heilongjiang, China
The Second Affiliated Hospital of Harbin Medical University
🇨🇳Haerbin, Heilongjiang, China
The First Affiliated Hospital of Henan University of Science And Technology
🇨🇳Luoyang, Henan, China
The First Affiliated Hospital of Xinxiang Medical University
🇨🇳Xinxiang, Henan, China
Henan Provincial People's Hospital
🇨🇳Zhengzhou, Henan, China
The First Affiliated Hospital of Zhengzhou University
🇨🇳Zhengzhou, Henan, China
Huang Gang Central Hospital
🇨🇳Huanggang, Hubei, China
Hubei Provincial Hospital Of TCM
🇨🇳Wuhan, Hubei, China
Wuhan Integrated TCM & Western Medicine Hospital
🇨🇳Wuhan, Hubei, China
The Second Xiang Ya Hospital of Central South University
🇨🇳Changsha, Hunan, China
The Third Xiang Ya Hospital of Central South University
🇨🇳Changsha, Hunan, China
Zhong Nan Hospital of Wuhan University
🇨🇳Wuhan, Hubei, China
Xiangya Hospital Central South University
🇨🇳Changsha, Hunan, China
Jiangsu Province Hospital of Traditional Chinese Medicine
🇨🇳Nanjing, Jiangsu, China
Affiliated Hospital of Nantong University
🇨🇳Nantong, Jiangsu, China
Jiangsu Provincial People's Hospital
🇨🇳Nanjing, Jiangsu, China
Jiangsu Taizhou People's Hospital
🇨🇳Taizhou, Jiangsu, China
Taizhou Traditional Chinese Medicine Hospital
🇨🇳Taizhou, Jiangsu, China
Xuzhou Central Hospital
🇨🇳Xuzhou, Jiangsu, China
Chinese People's Liberation Army No.94 Hospital
🇨🇳Nanchang, Jiangxi, China
Jiangxi Provincial People's Hospital
🇨🇳Nanchang, Jiangxi, China
The First Affiliated Hospital Of Nanchang University
🇨🇳Nanchang, Jiangxi, China
The Second Affiliated Hospital Of Nanchang University
🇨🇳Nanchang, Jiangxi, China
Jiangxi Pingxiang People's Hospital
🇨🇳Pingxiang, Jiangxi, China
The First Hospital of Jilin University
🇨🇳Changchun, Jilin, China
The Second Hospital Of Jilin University
🇨🇳Changchun, Jilin, China
Dalian Municipal Central Hospital Affiliated Of Dalian Medical University
🇨🇳Dalian, Liaoning, China
The First Affiliated Hospital Of Dalian Medical University
🇨🇳Dalian, Liaoning, China
First Affiliated Hospital of Liaoning Medical University
🇨🇳Jinzhou, Liaoning, China
Shengjing Hospital of China Medical University
🇨🇳Shenyang, Liaoning, China
People's Liberation Army No.202 Hospital
🇨🇳Shenyang, Liaoning, China
The General Hospital Of Shenyang Military Region
🇨🇳Shenyang, Liaoning, China
Jinan General Hospital of PLA
🇨🇳Jinan, Shandong, China
The General Hospital of Ningxia Medical University
🇨🇳Yinchuan, Ningxia, China
Qi Lu Hospital of Shandong University
🇨🇳Jinan, Shandong, China
Affiliated Hospital of Jining Medical University
🇨🇳Jining, Shandong, China
Chinese People's Liberation Army No.88 Hospital
🇨🇳Taian, Shandong, China
Yantai Yu Huang Ding Hospital
🇨🇳Yantai, Shandong, China
Zaozhuang Municipal Hospital
🇨🇳Zaozhuang, Shandong, China
Ren Ji Hospital of Shanghai Jiao Tong University School of Medicine
🇨🇳Shanghai, Shanghai, China
Shanghai Sixth People's Hospital Affiliated Shanghai Jiao Tong University School of Medicine
🇨🇳Shanghai, Shanghai, China
The First Hospital of Shanxi Medical University
🇨🇳Taiyuan, Shanxi, China
The Second Hospital of Shanxi Medical University
🇨🇳Taiyuan, Shanxi, China
Shanxi Provincial People's Hospital
🇨🇳Xian, Shanxi, China
The First Affiliated Hospital of Xi'an Jiao Tong University
🇨🇳Xian, Shanxi, China
Hua Xi Hospital of Sichuan University
🇨🇳Chengdu, Sichuan, China
First Teaching Hospital of Tianjin University of Traditional Chinese Medicine
🇨🇳Tianjin, Tianjin, China
The Second Hospital of Tianjin Medical University
🇨🇳Tianjin, Tianjin, China
Zhejiang Provincial People's Hospital
🇨🇳Hangzhou, Zhejiang, China
Tianjin Hospital of ITCWM, Nankai Hospital
🇨🇳Tianjin, Tianjin, China
The First Hospital of Shi He Zi Medical University
🇨🇳Shihezi, Xinjiang, China
The Second Affiliated Hospital of Kunming Medical University
🇨🇳Kunming, Yunnan, China
Yan'an Hospital of Kunming City
🇨🇳Kunming, Yunnan, China
The First Hospital Of China Medical University
🇨🇳Shenyang, Liaoning, China