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

Primary Purpose

Chronic Kidney Diseases

Status
Enrolling by invitation
Phase
Phase 2
Locations
Taiwan
Study Type
Interventional
Intervention
Pu Yang Wan Wu Tang plus Pentoxifylline
Pentoxifylline
Sponsored by
Taipei Medical University Hospital
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Chronic Kidney Diseases

Eligibility Criteria

20 Years - 80 Years (Adult, Older Adult)All SexesDoes not accept 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.

Sites / Locations

  • Taipei Medical University

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Active Comparator

Arm Label

Pu Yang Wan Wu Tang plus Pentoxifylline

Pentoxifylline

Arm Description

Outcomes

Primary Outcome Measures

Value of eGFR
Value of eGFR
Value of eGFR
Value of eGFR

Secondary Outcome Measures

Value of Creatinine
Value of Creatinine
Value of Creatinine
Value of Creatinine
Value of BUN
Value of BUN
Value of BUN
Value of BUN
Ratio of Urine Protein/Urine Creatinine
Ratio of Urine Protein/Urine Creatinine
Ratio of Urine Protein/Urine Creatinine
Ratio of Urine Protein/Urine Creatinine
Value of GOT
Value of GOT
Value of GOT
Value of GOT
Value of GPT
Value of GPT
Value of GPT
Value of GPT

Full Information

First Posted
May 11, 2022
Last Updated
June 23, 2023
Sponsor
Taipei Medical University Hospital
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1. Study Identification

Unique Protocol Identification Number
NCT05387187
Brief Title
Evaluate the Effect and Safety of Pu Yang Wan Wu Tang and Western Medicine on Chronic Kidney Disease
Official Title
Evaluate the Effect and Safety of Pu Yang Wan Wu Tang and Western Medicine on Chronic Kidney Disease
Study Type
Interventional

2. Study Status

Record Verification Date
June 2023
Overall Recruitment Status
Enrolling by invitation
Study Start Date
May 1, 2022 (Actual)
Primary Completion Date
May 31, 2022 (Actual)
Study Completion Date
June 20, 2023 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Taipei Medical University Hospital

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Chronic Kidney Diseases

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 2, Phase 3
Interventional Study Model
Parallel Assignment
Masking
ParticipantCare ProviderInvestigatorOutcomes Assessor
Allocation
Randomized
Enrollment
40 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Pu Yang Wan Wu Tang plus Pentoxifylline
Arm Type
Experimental
Arm Title
Pentoxifylline
Arm Type
Active Comparator
Intervention Type
Drug
Intervention Name(s)
Pu Yang Wan Wu Tang plus Pentoxifylline
Intervention Description
Pu Yang Wan Wu Tang 5g TID Pentoxifylline 100mg TID
Intervention Type
Drug
Intervention Name(s)
Pentoxifylline
Intervention Description
Pentoxifylline 100mg TID
Primary Outcome Measure Information:
Title
Value of eGFR
Time Frame
At baseline
Title
Value of eGFR
Time Frame
At 4-weeks
Title
Value of eGFR
Time Frame
At 8-weeks
Title
Value of eGFR
Time Frame
At 12-weeks
Secondary Outcome Measure Information:
Title
Value of Creatinine
Time Frame
At baseline
Title
Value of Creatinine
Time Frame
At 4-weeks
Title
Value of Creatinine
Time Frame
At 8-weeks
Title
Value of Creatinine
Time Frame
At 12-weeks
Title
Value of BUN
Time Frame
At baseline
Title
Value of BUN
Time Frame
At 4-weeks
Title
Value of BUN
Time Frame
At 8-weeks
Title
Value of BUN
Time Frame
At 12-weeks
Title
Ratio of Urine Protein/Urine Creatinine
Time Frame
At baseline
Title
Ratio of Urine Protein/Urine Creatinine
Time Frame
At 4-weeks
Title
Ratio of Urine Protein/Urine Creatinine
Time Frame
At 8-weeks
Title
Ratio of Urine Protein/Urine Creatinine
Time Frame
At 12-weeks
Title
Value of GOT
Time Frame
At baseline
Title
Value of GOT
Time Frame
At 4-weeks
Title
Value of GOT
Time Frame
At 8-weeks
Title
Value of GOT
Time Frame
At 12-weeks
Title
Value of GPT
Time Frame
At baseline
Title
Value of GPT
Time Frame
At 4-weeks
Title
Value of GPT
Time Frame
At 8-weeks
Title
Value of GPT
Time Frame
At 12-weeks

10. Eligibility

Sex
All
Minimum Age & Unit of Time
20 Years
Maximum Age & Unit of Time
80 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
PO-HSUAN SU, MD
Organizational Affiliation
Taipei Medical University Hospital
Official's Role
Principal Investigator
Facility Information:
Facility Name
Taipei Medical University
City
Taipei
ZIP/Postal Code
110
Country
Taiwan

12. IPD Sharing Statement

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

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