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

T

Taipei Medical University

Status and phase

Invitation-only
Phase 3
Phase 2

Conditions

Chronic Kidney Diseases

Treatments

Drug: Pentoxifylline
Drug: Pu Yang Wan Wu Tang plus Pentoxifylline

Study type

Interventional

Funder types

Other

Identifiers

NCT05387187
N202204011

Details and patient eligibility

About

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.

Enrollment

40 estimated patients

Sex

All

Ages

20 to 80 years old

Volunteers

No Healthy Volunteers

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.

Trial design

Primary purpose

Treatment

Allocation

Randomized

Interventional model

Parallel Assignment

Masking

Quadruple Blind

40 participants in 2 patient groups

Pu Yang Wan Wu Tang plus Pentoxifylline
Experimental group
Treatment:
Drug: Pu Yang Wan Wu Tang plus Pentoxifylline
Pentoxifylline
Active Comparator group
Treatment:
Drug: Pentoxifylline

Trial contacts and locations

1

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Data sourced from clinicaltrials.gov

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