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
About this trial
This is an interventional treatment trial for Chronic Kidney Diseases
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.
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
NCT ID
NCT05387187
First Posted
May 11, 2022
Last Updated
June 23, 2023
Sponsor
Taipei Medical University Hospital
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
Learn more about this trial
Evaluate the Effect and Safety of Pu Yang Wan Wu Tang and Western Medicine on Chronic Kidney Disease
We'll reach out to this number within 24 hrs