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Efficacy and Safety of Abelmo...

Efficacy and Safety of Abelmoschus Manihot for IgA Nephropathy

Last Updated: 2016-07-06

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

UNKNOWN

Clinical Phase

PHASE4

Total Enrollment

1600 participants

Study Classification

INTERVENTIONAL

Study Start Date

2014-09-30

Study Completion Date

2017-12-31

Brief Summary

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-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.

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Detailed Description

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The test has not been completed .

Conditions

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IgA Nephropathy

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

DOUBLE

Participants Caregivers

Study Groups

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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.

Group Type EXPERIMENTAL

Abelmoschus manihot

Intervention Type DRUG

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.

Losartan

Losartan potassium (Hangzhou MSD Pharmaceutical Co., Ltd.), 100 mg × 7 capsules/box.

Group Type EXPERIMENTAL

Losartan

Intervention Type DRUG

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.

Interventions

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Losartan

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.

Intervention Type 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.

Intervention Type DRUG

Other Intervention Names

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Cozaar Huangkui Capsule

Eligibility Criteria

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Inclusion Criteria

* 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

Exclusion Criteria

* 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

Minimum Eligible Age

18 Years

Maximum Eligible Age

65 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Responsible Party

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Chen Xiangmei

professor

Responsibility Role SPONSOR_INVESTIGATOR

Principal Investigators

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Xiangmei Chen, MD.& Ph.D

Role: PRINCIPAL_INVESTIGATOR

Department of Nephrology,State Key Laboratory of Kidney Disease,National Clinical Research Center for Kidney Disease, Chinese PLA General Hospital

Locations

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The First Hospital of Anhui Medical University

Hefei, Anhui, China

Site Status COMPLETED