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

NCT ID: NCT05387187

Last Updated: 2023-06-26

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.

Recruitment Status

UNKNOWN

Clinical Phase

PHASE2/PHASE3

Total Enrollment

40 participants

Study Classification

INTERVENTIONAL

Study Start Date

2022-05-01

Study Completion Date

2023-06-20

Brief Summary

Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.

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.

Detailed Description

Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.

Conditions

See the medical conditions and disease areas that this research is targeting or investigating.

Chronic Kidney Diseases

Study Design

Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.

Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

QUADRUPLE

Participants Caregivers Investigators Outcome Assessors

Study Groups

Review each arm or cohort in the study, along with the interventions and objectives associated with them.

Pu Yang Wan Wu Tang plus Pentoxifylline

Group Type EXPERIMENTAL

Pu Yang Wan Wu Tang plus Pentoxifylline

Intervention Type DRUG

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

Pentoxifylline

Group Type ACTIVE_COMPARATOR

Pentoxifylline

Intervention Type DRUG

Pentoxifylline 100mg TID

Interventions

Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.

Pu Yang Wan Wu Tang plus Pentoxifylline

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

Intervention Type DRUG

Pentoxifylline

Pentoxifylline 100mg TID

Intervention Type DRUG

Eligibility Criteria

Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.

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.
Minimum Eligible Age

20 Years

Maximum Eligible Age

80 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

Meet the organizations funding or collaborating on the study and learn about their roles.

Taipei Medical University Hospital

OTHER

Sponsor Role lead

Responsible Party

Identify the individual or organization who holds primary responsibility for the study information submitted to regulators.

Su, Po-Hsuan

Principal Investigator

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

Learn about the lead researchers overseeing the trial and their institutional affiliations.

PO-HSUAN SU, MD

Role: PRINCIPAL_INVESTIGATOR

Taipei Medical University Hospital

Locations

Explore where the study is taking place and check the recruitment status at each participating site.

Taipei Medical University

Taipei, , Taiwan

Site Status

Countries

Review the countries where the study has at least one active or historical site.

Taiwan

Other Identifiers

Review additional registry numbers or institutional identifiers associated with this trial.

N202204011

Identifier Type: -

Identifier Source: org_study_id

More Related Trials

Additional clinical trials that may be relevant based on similarity analysis.