NCT00672451

Rhubarb and Angiotensin Converting Enzyme Inhibitor

• Status: Terminated
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 8 (actual)
• Sponsor: Wake Forest University · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

Rhubarb extract is a chinese herbal preparation that is used in china and other asian countries to treat constipation and chronic kidney disease. Use of angiotensin converting enzyme inhibitors (ACEI) in diabetic kidney disease has been shown to be beneficial in slowing progression. The purpose of this study is to determine the combined effect of rhubarb plus enalapril (an ACEI)in slowing the rate of decline of CKD in people with kidney disease from diabetes.

Detailed description

Use of angiotensin converting enzyme inhibitors (ACEI) in diabetic nephropathy has been shown to be beneficial in slowing progression of disease. This would include use of ACEI, aggressive blood pressure and blood sugar control as well as other possible interventions. Experimental studies in chronic kidney disease (CKD) patients in China has suggested that rhubarb extract when used alone is equivalent to the protection afforded by ACEI. Furthermore when used in combination with ACEI, the renoprotective effect of rhubarb appears to be additive. Rhubarb extract is a chinese herbal preparation that is used extensively in china and other asian countries to treat constipation and CKD. Its mechanism of action in preventing progression of CKD is uncertain but perhaps related to TGF beta and TNF alpha inhibition. The specific aim is to determine the combined effect of rhubarb plus enalapril slowing the rate of decline of CKD (using Iothalamate GFRs) in patients in diabetes. A secondary aim would be to measure serum TGF beta concentrations over time and see if any observed decrease in the rate of decline of CKD is related to changes in TGF beta levels.

Conditions

• Diabetic Kidney Disease

Interventions

Type	Name	Description
DIETARY_SUPPLEMENT	rhubarb extract	titrate rhubarb extract titrated up to 6grams daily by mouth
DIETARY_SUPPLEMENT	placebo	placebo titrated up to 6 pills daily as patient tolerates

Timeline

• Start date: 2008-01-01
• Primary completion: 2009-05-01
• Completion: 2009-05-01
• First posted: 2008-05-06
• Last updated: 2018-12-13
• Results posted: 2018-11-15

Locations

1 site across 1 country: United States

Regulatory

• FDA-regulated drug study