NCT05387187

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.

Trial Health

43
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
40

participants targeted

Target at P25-P50 for phase_2

Timeline
Completed

Started May 2022

Shorter than P25 for phase_2

Geographic Reach
1 country

1 active site

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

May 1, 2022

Completed
10 days until next milestone

First Submitted

Initial submission to the registry

May 11, 2022

Completed
13 days until next milestone

First Posted

Study publicly available on registry

May 24, 2022

Completed
7 days until next milestone

Primary Completion

Last participant's last visit for primary outcome

May 31, 2022

Completed
1.1 years until next milestone

Study Completion

Last participant's last visit for all outcomes

June 20, 2023

Completed
Last Updated

June 26, 2023

Status Verified

June 1, 2023

Enrollment Period

1 month

First QC Date

May 11, 2022

Last Update Submit

June 23, 2023

Conditions

Chronic Kidney Diseases

Outcome Measures

Primary Outcomes (4)

  • Value of eGFR

    At baseline

  • Value of eGFR

    At 4-weeks

  • Value of eGFR

    At 8-weeks

  • Value of eGFR

    At 12-weeks

Secondary Outcomes (20)

  • Value of Creatinine

    At baseline

  • Value of Creatinine

    At 4-weeks

  • Value of Creatinine

    At 8-weeks

  • Value of Creatinine

    At 12-weeks

  • Value of BUN

    At baseline

  • +15 more secondary outcomes

Study Arms (2)

Pu Yang Wan Wu Tang plus Pentoxifylline

EXPERIMENTAL
Drug: Pu Yang Wan Wu Tang plus Pentoxifylline

Pentoxifylline

ACTIVE COMPARATOR
Drug: Pentoxifylline

Interventions

Pu Yang Wan Wu Tang plus PentoxifyllineDRUG

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

Pu Yang Wan Wu Tang plus Pentoxifylline
PentoxifyllineDRUG

Pentoxifylline 100mg TID

Pentoxifylline

Eligibility Criteria

Age20 Years - 80 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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.

You may not qualify if:

  • 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.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Taipei Medical University

Taipei, 110, Taiwan

Location

MeSH Terms

Conditions

Renal Insufficiency, Chronic

Interventions

Pentoxifylline

Condition Hierarchy (Ancestors)

Renal InsufficiencyKidney DiseasesUrologic DiseasesFemale Urogenital DiseasesFemale Urogenital Diseases and Pregnancy ComplicationsUrogenital DiseasesMale Urogenital DiseasesChronic DiseaseDisease AttributesPathologic ProcessesPathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

TheobromineXanthinesPurinonesPurinesHeterocyclic Compounds, 2-RingHeterocyclic Compounds, Fused-RingHeterocyclic Compounds

Study Officials

  • PO-HSUAN SU, MD

    Taipei Medical University Hospital

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
phase 2
Allocation
RANDOMIZED
Masking
QUADRUPLE
Who Masked
PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Principal Investigator

Study Record Dates

First Submitted

May 11, 2022

First Posted

May 24, 2022

Study Start

May 1, 2022

Primary Completion

May 31, 2022

Study Completion

June 20, 2023

Last Updated

June 26, 2023

Record last verified: 2023-06

Locations

TW(1)