Brief Summary

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.

Trial Health

At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date

Enrollment

1,600

participants targeted

Target at P75+ for phase_4

Timeline

Completed

Started Sep 2014

Typical duration for phase_4

Geographic Reach

1 country

78 active sites

Status

unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

2.3 years study duration

First Submitted

Initial submission to the registry

August 30, 2014

Completed

2 days until next milestone

Study Start

First participant enrolled

September 1, 2014

Completed

3 days until next milestone

First Posted

Study publicly available on registry

September 4, 2014

Completed

1.3 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

January 1, 2016

Completed

11 months until next milestone

Study Completion

Last participant's last visit for all outcomes

December 1, 2016

Completed

Last Updated

June 1, 2016

Status Verified

May 1, 2016

Enrollment Period

1.3 years

First QC Date

August 30, 2014

Last Update Submit

May 31, 2016

Conditions

Chronic Kidney Disease

Keywords

Abelmoschus manihotChronic Kidney Diseaseproteinuriaefficacysafety

Outcome Measures

Primary Outcomes (1)

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

Secondary Outcomes (2)

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

Study Arms (1)

Abelmoschus manihot (AM)

EXPERIMENTAL

* 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

Drug: Abelmoschus manihot (AM)

Interventions

Abelmoschus manihot (AM)DRUG

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.

Also known as: Huanghui capsule

Abelmoschus manihot (AM)

Eligibility Criteria

Sexall

Healthy VolunteersNo

Age GroupsChild (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

Clinical diagnosed as non-ESRD chronic kidney disease (stage I-IV)
Blood pressure of ≤140/90mmHg
Obtaining the signed informed consent from patients

You may not qualify if:

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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Chinese PLA General Hospitallead
Jiangsu Suzhong Pharmaceutical Group Co., Ltd.collaborator

Study Sites (78)

The Second Hospital of Anhui Medical University

Hefei, Anhui, 230000, China

Location

Beijing Military General Hospital