Efficacy and Safety of Abelmoschus Manihot for IgA Nephropathy

Efficacy and Safety of Abelmoschus Manihot for IgA Nephropathy: a Multicentre, Double-blind, Double-dummy, Randomized Controlled Trial

Status

UNKNOWN

Phases

Phase 4

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT02231125

Enrollment

1600

Registered

2014-09-04

Start date

2014-09-30

Completion date

2017-12-31

Last updated

2016-07-06

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

IgA Nephropathy

Keywords

Abelmoschus manihot, IgA Nephropathy, proteinuria, efficacy, safety

Brief summary

-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.

Detailed description

The test has not been completed .

Interventions

DRUGLosartan

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.

DRUGAbelmoschus 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.

Study design

Allocation

RANDOMIZED

Intervention model

PARALLEL

Primary purpose

TREATMENT

Masking

DOUBLE (Subject, Caregiver)

Eligibility

Sex/Gender

ALL

Age

18 Years to 65 Years

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

Design outcomes

Primary

Measure	Time frame
Change in 24-h proteinuria from baseline after treatment	Baseline(week 0), week 4, week 12, week 24, week 36, week 48

Secondary

Measure	Time frame
Change in serum creatinine from baseline after treatment	Baseline(week 0), week 4, week 12, week 24, week 36, week 48
Change in estimated glomerular filtration rate (eGFR) from baseline after treatment	Baseline(week 0), week 4, week 12, week 24, week 36, week 48

Countries

China

Contacts

Primary ContactXiangmei Chen, MD.&Ph.D

xmchen301@126.com+86-10-66935462

Backup ContactXuefeng Sun, MD.&Ph.D

xfssun@126.com+86-10-66937077

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 27, 2026