Dextromethorphan and Silymarin in Chronic Kidney Disease (CKD) Patients

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

UNKNOWN

Clinical Phase

PHASE3

Total Enrollment

45 participants

Study Classification

INTERVENTIONAL

Study Start Date

2010-01-31

Study Completion Date

2010-07-31

Brief Summary

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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.

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Detailed Description

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Conditions

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Proteinuria

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

QUADRUPLE

Participants Caregivers Investigators Outcome Assessors

Study Groups

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Dextromethorphan

Group Type ACTIVE_COMPARATOR

Dextromethorphan

Intervention Type DRUG

60 mg, bid

Silymarin

Group Type ACTIVE_COMPARATOR

Silymarin

Intervention Type DRUG

150 mg , tid

sugar pill

Group Type PLACEBO_COMPARATOR

sugar pill

Intervention Type DRUG

placebo

Interventions

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Dextromethorphan

60 mg, bid

Intervention Type DRUG

Silymarin

150 mg , tid

Intervention Type DRUG

sugar pill

placebo

Intervention Type DRUG

Eligibility Criteria

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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.

Minimum Eligible Age

18 Years

Maximum Eligible Age

75 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No