Efficacy and Safety of Abelmoschus Manihot for Chronic Kidney Disease

Chinese PLA General Hospital (301 Hospital)

Status and phase: Unknown; Phase 4

Conditions: Chronic Kidney Disease

Treatments: Drug: Abelmoschus manihot (AM)

Study type: Interventional

Funder types: Other; Industry

Identifiers

NCT02231138

S2014-040-01

Details and patient eligibility

About

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.

Full description

The test has not been completed.

Enrollment: 1,600 estimated patients

Sex: All

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: N/A

Interventional model: Single Group Assignment

Masking: None (Open label)

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1,600 participants in 1 patient group

Abelmoschus manihot (AM)

Experimental group

Description:

* 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

Treatment:

Drug: Abelmoschus manihot (AM)