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Status unknownNCT05387187Updated Jun 26, 2023

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

A Phase 2/3 interventional study of Pu Yang Wan Wu Tang plus Pentoxifylline and Pentoxifylline in Chronic Kidney Diseases, sponsored by Taipei Medical University Hospital. Status unknown at 1 site in Taiwan. Open to participants aged 20 Years to 80 Years. Per ClinicalTrials.gov, last updated 2023-06-26.

Sponsored by Taipei Medical University Hospital · Phase 2/3, Interventional, and Treatment

The sponsor has not verified this record recently (last verified Jun 2023), so the status shown — last known as Enrolling by invitation — may be out of date.
Phase
Phase 2/3
Study type
Interventional
Enrollment
40
Allocation
Randomized
Ages
20 Years to 80 Years
Sex
All
01

Study 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.

02

Conditions studied

  • Chronic Kidney Diseases
03

In context

Renal Insufficiency, Chronic

3,224 studies on the registry are indexed under Renal Insufficiency, Chronic; 706 are open to participants now.

This study's planned enrollment of 40 is below the median of 74 across 2,229 interventional studies indexed under Renal Insufficiency, Chronic.

Browse Renal Insufficiency, Chronic studies →

Lead sponsor

Taipei Medical University Hospital is the lead sponsor of 64 studies on the registry; 12 are open to participants now.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
20 Years to 80 Years
Sexes eligible
All
Accepts healthy volunteers
No

Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.

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

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.
05

Study design

Phase
Phase 2 / Phase 3
Primary purpose
Treatment
Allocation
Randomized
Intervention model
Parallel assignment
Masking
Quadruple (Participant, Care provider, Investigator, Outcomes assessor)
Enrollment
40 participants (estimated)

Study arms

  • Experimental
    Pu Yang Wan Wu Tang plus Pentoxifylline

    Drug: Pu Yang Wan Wu Tang plus Pentoxifylline

  • Active comparator
    Pentoxifylline

    Drug: Pentoxifylline

Interventions

  • DrugPu Yang Wan Wu Tang plus Pentoxifylline

    Pu Yang Wan Wu Tang 5g TID Pentoxifylline 100mg TID

  • DrugPentoxifylline

    Pentoxifylline 100mg TID

06

What researchers measure

Primary outcomes

  1. Value of eGFR

    Time frame: At baseline

  2. Value of eGFR

    Time frame: At 4-weeks

  3. Value of eGFR

    Time frame: At 8-weeks

  4. Value of eGFR

    Time frame: At 12-weeks

Secondary outcomes

  1. Value of Creatinine

    Time frame: At baseline

  2. Value of Creatinine

    Time frame: At 4-weeks

  3. Value of Creatinine

    Time frame: At 8-weeks

  4. Value of Creatinine

    Time frame: At 12-weeks

  5. Value of BUN

    Time frame: At baseline

  6. Value of BUN

    Time frame: At 4-weeks

  7. Value of BUN

    Time frame: At 8-weeks

  8. Value of BUN

    Time frame: At 12-weeks

  9. Ratio of Urine Protein/Urine Creatinine

    Time frame: At baseline

  10. Ratio of Urine Protein/Urine Creatinine

    Time frame: At 4-weeks

  11. Ratio of Urine Protein/Urine Creatinine

    Time frame: At 8-weeks

  12. Ratio of Urine Protein/Urine Creatinine

    Time frame: At 12-weeks

  13. Value of GOT

    Time frame: At baseline

  14. Value of GOT

    Time frame: At 4-weeks

  15. Value of GOT

    Time frame: At 8-weeks

  16. Value of GOT

    Time frame: At 12-weeks

  17. Value of GPT

    Time frame: At baseline

  18. Value of GPT

    Time frame: At 4-weeks

  19. Value of GPT

    Time frame: At 8-weeks

  20. Value of GPT

    Time frame: At 12-weeks

07

Study locations

1 site
  • Taipei Medical University
    Taipei, 110, Taiwan
08

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Jun 26, 2023, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
09

Registry details

Key details

Study ID
NCT05387187
Lead sponsor
Taipei Medical University Hospital
Responsible party
Su, Po-Hsuan (Principal Investigator, Taipei Medical University Hospital) — Principal investigator
First posted
May 24, 2022
Start date
May 1, 2022
Primary completion
May 31, 2022
Completion
Jun 20, 2023 (estimated)
Last update
Jun 26, 2023

Study contacts

PO-HSUAN SU, MD
principal investigator · Taipei Medical University Hospital

Oversight

FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is status unknown, as verified in Jun 2023. You cannot join it, but the record below documents what was studied.

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Discussion

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