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

Phase 2

• Conditions: Chronic Kidney Diseases
• Interventions: Drug: Pu Yang Wan Wu Tang plus Pentoxifylline; Drug: Pentoxifylline

• Registration Number: NCT05387187
• Lead Sponsor: Taipei Medical University Hospital

Brief Summary

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.

Detailed Description

Not available

Study Timeline

• Study Start: 2022-05-01
• Study First Submitted: 2022-05-11
• Study First Submitted QC: 2022-05-18
• Study First Posted: 2022-05-24
• Primary Completion: 2022-05-31
• Status Verified: 2023-06
• Study Completion: 2023-06-20
• Last Update Submitted: 2023-06-23
• Last Update Posted: 2023-06-26

Recruitment & Eligibility

• Status: ENROLLING_BY_INVITATION
• Sex: All
• Target Recruitment: 40

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 & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Pu Yang Wan Wu Tang plus Pentoxifylline	Pu Yang Wan Wu Tang plus Pentoxifylline	-
Pentoxifylline	Pentoxifylline	-

Primary Outcome Measures

Name	Time	Method
Value of eGFR	At 12-weeks

Secondary Outcome Measures

Name	Time	Method
Value of Creatinine	At 12-weeks
Ratio of Urine Protein/Urine Creatinine	At 12-weeks
Value of GOT	At 12-weeks
Value of BUN	At 12-weeks
Value of GPT	At 12-weeks

Trial Locations

Locations (1)

Taipei Medical University; 🇨🇳 Taipei, Taiwan