Evaluate the Effect and Safety of Pu Yang Wan Wu Tang and Western Medicine on Chronic Kidney Disease

Study Overview
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Brief Summary
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The indication of Pu Yang Wan Wu Tang is stroke sequelae, such as half body paralysis, aphasia and muscle weakness. Pu Yang Wan Wu Tang is proved to have the effect of protecting nerve and blood vessel, anti-inflammation, anti-coagulation, dilating peripheral vessel, promot-ing micro circulation, improving hemodynamics, and activating central nerve system. Huangqi could attenuate podocyte injury by regulating the expression and distribu-tion of nephrin and podocin. Huangqi and Danggui are associated with fewer infiltra-tion of macrophages and limitation of renal intrinsic cell activation, which may lead to earlier and persistent reduction of proteinuria. This research will use the compound Chinese medicine, Pu Yang Wan Wu Tang. Those treatments combined Western medicine to assess the efficacy and drug safety on the CKD cases. Series of blood and urine were collected regularly during study to prove the role of Chinese medicine in the treatment of CKD, and to assess their drug safety. The final goal of the plan is to establish the new indication of Pu Yang Wan Wu Tang and enhance the interaction and cooperation between Chinese and Western medicine.

Official Title
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Evaluate the Effect and Safety of Pu Yang Wan Wu Tang and Western Medicine on Chronic Kidney Disease

Conditions
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Chronic Kidney Diseases

Intervention / Treatment
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* Drug: Pu Yang Wan Wu Tang plus Pentoxifylline
* Drug: Pentoxifylline


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Participants' age is between 20 to 80 years. Participants CKD stage are from 2 to 4(eGFR from 89 to 15) Participants under regular western medicine therapy. Participants who agree to follow the trial protocol. Participants who can complete the study treatment and assessments. Exclusion Criteria: Participants who are already under hemodialysis, Peritoneal Dialysis or kidney transplant. Participants who are participating in other clinical trials. Participants with hematopoietic system diseases, severe psychiatric or psychological disorder, or cancer. Women who are pregnant.

Ages Eligible for Study
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Minimum Age: 20 Years
Maximum Age: 80 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Pu Yang Wan Wu Tang plus Pentoxifylline<br> | Drug: Pu Yang Wan Wu Tang plus Pentoxifylline<br>* Pu Yang Wan Wu Tang 5g TID Pentoxifylline 100mg TID<br>|
| Active Comparator: Pentoxifylline<br> | Drug: Pentoxifylline<br>* Pentoxifylline 100mg TID<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Value of eGFR |  | At baseline | 
| Value of eGFR |  | At 4-weeks | 
| Value of eGFR |  | At 8-weeks | 
| Value of eGFR |  | At 12-weeks | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Value of Creatinine |  | At baseline | 
| Value of Creatinine |  | At 4-weeks | 
| Value of Creatinine |  | At 8-weeks | 
| Value of Creatinine |  | At 12-weeks | 
| Value of BUN |  | At baseline | 
| Value of BUN |  | At 4-weeks | 
| Value of BUN |  | At 8-weeks | 
| Value of BUN |  | At 12-weeks | 
| Ratio of Urine Protein/Urine Creatinine |  | At baseline | 
| Ratio of Urine Protein/Urine Creatinine |  | At 4-weeks | 
| Ratio of Urine Protein/Urine Creatinine |  | At 8-weeks | 
| Ratio of Urine Protein/Urine Creatinine |  | At 12-weeks | 
| Value of GOT |  | At baseline | 
| Value of GOT |  | At 4-weeks | 
| Value of GOT |  | At 8-weeks | 
| Value of GOT |  | At 12-weeks | 
| Value of GPT |  | At baseline | 
| Value of GPT |  | At 4-weeks | 
| Value of GPT |  | At 8-weeks | 
| Value of GPT |  | At 12-weeks |