This trial is active, not recruiting.

Condition chronic kidney disease
Treatment abelmoschus manihot (am)
Phase phase 4
Sponsor Chinese PLA General Hospital
Collaborator Jiangsu Suzhong Pharmaceutical Group Co., Ltd.
Start date September 2014
End date January 2016
Trial size 1600 participants
Trial identifier NCT02231138, S2014-040-01


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 chronic kidney disease in large scale samples with long time take.

United States No locations recruiting
Other countries No locations recruiting

Study Design

Endpoint classification safety/efficacy study
Intervention model single group assignment
Masking open label
Primary purpose treatment
age above 12 years old (including 12):huangkui capsule are given orally at 2.5 g three times per day age between 6-12 years old(including 6):huangkui capsule are given orally at 1.5 g three times per day age under 6 years old:huangkui capsule are given orally at 1.0 g three times per day
abelmoschus manihot (am) Huanghui capsule
Abelmoschus manihot (AM): Huanghui 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.

Primary Outcomes

Change in 24-h proteinuria from baseline after treatment
time frame: Baseline(week 0), week 12, week 24

Secondary Outcomes

change in the serum creatinine level from baseline after treatment
time frame: Baseline(week 0), week 12, week 24
change in the estimated glomerular filtration rate (eGFR) from baseline after treatment
time frame: Baseline(week 0), week 12, week 24

Eligibility Criteria

Male or female participants of any age.

Inclusion Criteria: - Clinical diagnosed as non-ESRD chronic kidney disease (stage I-IV) - Blood pressure of ≤140/90mmHg - Obtaining the signed informed consent from patients Exclusion Criteria: - Be allergic to Huangkui Capsule - 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 - Lactation, pregnancy or plans pregnancy during the study period - Participating in another clinical study in the same period

Additional Information

Official title Efficacy and Safety of Abelmoschus Manihot for Chronic Kidney Disease:a Multicentre Open Study
Principal investigator Xiangmei Chen, MD.& Ph.D
Description The test has not been completed.
Trial information was received from ClinicalTrials.gov and was last updated in May 2016.
Information provided to ClinicalTrials.gov by Chinese PLA General Hospital.