NCT02662283

Validity and Security of Reh-acteoside Therapy for Patients of IgA Nephropathy

Validity and Security of Reh-acteoside Therapy for Patients of IgA Nephropathy -- A Prospective, Randomized, Controlled, Multi-Center Clinical Trial

• Status: Unknown
• Phase: Phase 2 / Phase 3
• Study type: Interventional
• Enrollment: 75 (estimated)
• Sponsor: Sun Yat-sen University · Academic / Other
• Sex: All
• Age: 14 Years – 70 Years
• Healthy volunteers: Not accepted

Summary

This prospective, randomized, controlled, multi-center clinical trial will evaluate the effect and security of reh-acteoside therapy for patients of IgA nephropathy.

Detailed description

Reh-acteoside (general acteoside of rehmanniae leaves) contains more than 10 kinds of bio-active mucopolysaeccharide, among which acteoside is the most effective ingredient, constituting 30 percent. It has been reported that acteoside can reduce mesangium lesion of IgA nephrology-model ddy-mice, mainly by reducing the expressing of TGF-β1, reducing proliferation of mesangial cell and glomerular sclerosis. Research also suggested that conjunctive use of reh-acteoside and benazepril showed better effect on reducing proteinurine than single use of benazepril, with no obvious side effect at the same time. Thus, we start this clinical trial to evaluate the effect and security of reh-acteoside therapy for patients of IgA nephropathy. We set 3 groups: methylprednisolone group, reh-acteoside group and methylprednisolone with reh-acteoside group. After followed-up for 8 weeks, remission of proteinuria and change of renal function will be evaluated.

Conditions

• IGA Nephropathy

Interventions

Type	Name	Description
DRUG	Prednisolone	Oral take prednisolone (0.5 mg/kg, qd) for 8 weeks
DRUG	Reh-acteoside	Oral take and reh-acteoside (0.4g bid) for 8 weeks

Timeline

• Start date: 2016-05-01
• Primary completion: 2016-11-01
• Completion: 2016-11-01
• First posted: 2016-01-25
• Last updated: 2016-02-02

Locations

1 site across 1 country: China