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

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.

Study Overview

• Status: Enrolling by invitation
• Conditions: Chronic Kidney Diseases
• Intervention / Treatment: Drug: Pu Yang Wan Wu Tang plus Pentoxifylline; Drug: Pentoxifylline

• Study Type: Interventional
• Enrollment (Estimated): 40
• Phase: Phase 2; Phase 3

Contacts and Locations

Study Locations

• Taiwan
  • Taipei, Taiwan, 110
    • Taipei Medical University

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 20 years to 80 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No

Description

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.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Quadruple

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Pu Yang Wan Wu Tang plus Pentoxifylline	Drug: Pu Yang Wan Wu Tang plus Pentoxifylline; Pu Yang Wan Wu Tang 5g TID Pentoxifylline 100mg TID
Active Comparator: Pentoxifylline	Drug: Pentoxifylline; Pentoxifylline 100mg TID

What is the study measuring?

Primary Outcome Measures

Outcome Measure	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	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

Collaborators and Investigators

• Sponsor: Taipei Medical University Hospital
• Investigators: Principal Investigator: PO-HSUAN SU, MD, Taipei Medical University Hospital

Study record dates

Study Major Dates

• Study Start (Actual): May 1, 2022
• Primary Completion (Actual): May 31, 2022
• Study Completion (Estimated): June 20, 2023

Study Registration Dates

• First Submitted: May 11, 2022
• First Submitted That Met QC Criteria: May 18, 2022
• First Posted (Actual): May 24, 2022

Study Record Updates

• Last Update Posted (Actual): June 26, 2023
• Last Update Submitted That Met QC Criteria: June 23, 2023
• Last Verified: June 1, 2023

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Pathologic Processes; Urologic Diseases; Disease Attributes; Renal Insufficiency; Chronic Disease; Female Urogenital Diseases; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Male Urogenital Diseases; Kidney Diseases; Renal Insufficiency, Chronic; Physiological Effects of Drugs; Molecular Mechanisms of Pharmacological Action; Vasodilator Agents; Enzyme Inhibitors; Platelet Aggregation Inhibitors; Protective Agents; Antioxidants; Phosphodiesterase Inhibitors; Free Radical Scavengers; Radiation-Protective Agents; Pentoxifylline
• Other Study ID Numbers: N202204011

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No