Efficacy and Safety of Abelmoschus Manihot for IgA Nephropathy

Chen Xiangmei

Status and phase: Unknown; Phase 4

Conditions: IgA Nephropathy

Treatments: Drug: Losartan; Drug: Abelmoschus manihot

Study type: Interventional

Funder types: Other; Industry

Identifiers

NCT02231125

S2014-039-01

Details and patient eligibility

About

-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.

Full description

The test has not been completed .

Enrollment: 1,600 estimated patients

Sex: All

Ages: 18 to 65 years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Double Blind

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1,600 participants in 2 patient groups

Abelmoschus manihot (AM)

Experimental group

Description:

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.

Treatment:

Drug: Abelmoschus manihot

Losartan

Experimental group

Description:

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

Treatment:

Drug: Losartan