the clinical effect of Fufang Shenyan Tablet on IgA Nephropathy patients

Multicenter, randomized, double-blind, placebo-controlled clinical research of the clinical effect of Fufang Shenyan Tablet on IgA Nephropathy patients

Status

Active, not recruiting

Phases

Phase 4

Study type

Interventional

Source

ChiCTR

Registry ID

ChiCTR-TRC-10000824

Enrollment

Unknown

Registered

2010-04-06

Start date

2010-01-01

Completion date

Unknown

Last updated

2017-04-18

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

Conditions

IgA Nephropathy

Interventions

the control group:The 24-hour urinary protein 0.5-2.0g: Lotensin 10mg, bid

placebos 2.5g tid

The 24-hour urinary protein 2.0-3.5g: on this basis, combined with prednisone 40mg/d

If patients with hypertension(target blood pressure <=130/80mmHg), used Lotensin 10mg bid alone control it difficultly, give Norvasc 5mg, qd~bid instead

if still poorly controlled, combined with Betaloc 12.5mg, bid

the treatment group:The 24-hour urinary protein 0.5-2.0g: Lotensin 10mg, bid

Fufang Shenyan Tablets 2.5g tid

If patients with hypertension (target blood pressure <=130/80mmHg), used Lotensin 10mg bid alone control it difficultly, give Norvasc 5mg, qd~bid instead

Eligibility

Sex/Gender

All

Age

18 Years to 65 Years

Inclusion criteria

Inclusion criteria: IgA Nephropathy patients (Lee's pathological grade II and III); diagnosed within 1 year can be selected after a elution period of 2 weeks; 18-65 years old, male or female;The 24-hour urinary protein >0.5g, <3.5g; Not used Corticosteroids/Other immunosuppressive agents/ACEI/ARB/Cytotoxic drugs/Anti-clotting drugs/Fibrinolysis drugs/ Traditional Chinese Medicine Patent Prescription within 2 weeks; if used, should be selected after a elution period of 2 weeks;Each Patient have signed the Informed consent.

Exclusion criteria

Exclusion criteria: Can't cooperate cure and review according to the requirements; Have accepted Relevant treatment that may influence the effect index; Bleeding tendency; Stage IV of CKD (GFR 15-29), or V (GFR <15), or undergoing hemodialysis; Combined with Heart, brain, liver and hematopoietic system disease; Lupus nephropathy, diabetic nephropathy, hypertensive nephropathy etc; Secondary IgA kidney disease; Serious vasculitis associated with IgA Nephropathy; Pregnancy and lactation patients; Serious complications, such as lung infection, hf, etc; Have incomplete or no legal capacity; Any other conditions that researchers think not suitable for this experiment.

Design outcomes

Primary

Measure	Time frame
The 24-hour urinary protein/BUN/GF;	—

Secondary

Measure	Time frame
ß2-MG/alpha1-MG/CHO/TG/Fib/CRP/IgA/IgG/IgM/complement;	—

Countries

China

Contacts

Public ContactYin Aiping

jybhxh@126.com+86 13096918256

Outcome results

None listed

Source: ChiCTR (via WHO ICTRP) · Data processed: Feb 4, 2026