Dextromethorphan and Silymarin in Chronic Kidney Disease (CKD) Patients

The Reno-protective and Cardiovascular Effect of Dextromethorphan and Silymarin in Patients With Chronic Kidney Disease

Status

UNKNOWN

Phases

Phase 3

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT01091324

Acronym

CKD

Enrollment

Registered

2010-03-24

Start date

2010-01-31

Completion date

2010-07-31

Last updated

2010-03-24

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

Conditions

Proteinuria

Keywords

CKD, proteinuria, dextromethorphan, silymarin, patients with 15 ml<eGFR< 60ml and 0.5 g/day<proteinuria<3g/day

Brief summary

The investigators test the renal and cardiovascular protective effects dextromethorphan and silymarin on patients with the proteinuric chronic kidney diseases, who enrolled in our clinical trial, had progressing kidney diseases and merit aggressive anti-inflammatory therapy.

Interventions

DRUGDextromethorphan

60 mg, bid

DRUGSilymarin

150 mg , tid

DRUGsugar pill

placebo

Study design

Allocation

RANDOMIZED

Intervention model

PARALLEL

Primary purpose

TREATMENT

Masking

QUADRUPLE (Subject, Caregiver, Investigator, Outcomes Assessor)

Eligibility

Sex/Gender

ALL

Age

18 Years to 75 Years

Healthy volunteers

Inclusion criteria

1. Patients with Stage 3 or 4 chronic kidney disease as measured by a Modification in Diet in Renal Disease Study (MDRD) estimate of between 15 ml/min and 59 ml/min and and 0.5 g/day\<proteinuria\<3g/day. 2. Age between 18 and 75 years old. 3. Patients without hospitalization for cardiac or infection related morbidity over the previous 2 months(due to the potential confounding effects on baseline study variables). 4. Patients who are able to provide consent to participate in the study.-

Exclusion criteria

1. patients will significant mental illness, pregnant women, and other vulnerable populations. 2. Patients with active hepatic disease and/or ALT \> 2.5 times upper limit of normal. 3. Patients with history of congestive heart failure and NYHA Class III-IV symptoms at any time. 4. Patients for whom living donor renal transplantation is already scheduled or in the process of being evaluated, as these patients will be unlikely to complete study protocols before transplantation. 5. Patients with severe co-morbid conditions (eg, symptomatic hepatic cirrhosis, metastatic cancer, HIV infection with AIDS). 6. Patient with active inflammatory process (eg., SLE, rheumatoid arthritis, gout) for which they are currently receiving immune modulating medications. 7. Patients who are on corticosteroid therapy. 8. Patients who do not consent to participate in the study.

Design outcomes

Primary

Measure	Time frame	Description
Endothelial function	4 months	by Flow-mediated dilatation mesured by Crdiovascular ultrasound
change of eGFR	4 months	Use MDRD-simplified equation
Change of Urine TP/Cr	4 months	—
Change of serum hsCRP	4 months	—
Change of urine TGF-beta/Cr level	4 months	fibrotic marker of kidney

Secondary

Measure	Time frame	Description
Leukocyte ROCK activity	4 months	Measure leukocyte Ro kinase activity by western blotting This is an indicator of cardiovascular function
Blood MDA level	4 months	Indicator of oxidative stress
Blood TGF-beta	4 months	By Elisa
Urine MCP-1/Cr level	4 months	—

Countries

Taiwan

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026