Clinical trial NCT05387187: 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
Overall status: UNKNOWN
Phase: PHASE2
PHASE3
Conditions: Chronic Kidney Diseases
Lead sponsor: Taipei Medical University Hospital
Sponsor class: OTHER
First posted: 2022-05-24
Enrollment: 40
Sex: ALL
Minimum age (years): 20
Maximum age (years): 80
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.


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.

Primary outcomes:
measure: Value of eGFR
timeFrame: At baseline
measure: Value of eGFR
timeFrame: At 4-weeks
measure: Value of eGFR
timeFrame: At 8-weeks
measure: Value of eGFR
timeFrame: At 12-weeks
Secondary outcomes:
measure: Value of Creatinine
timeFrame: At baseline
measure: Value of Creatinine
timeFrame: At 4-weeks
measure: Value of Creatinine
timeFrame: At 8-weeks
measure: Value of Creatinine
timeFrame: At 12-weeks
measure: Value of BUN
timeFrame: At baseline
measure: Value of BUN
timeFrame: At 4-weeks
measure: Value of BUN
timeFrame: At 8-weeks
measure: Value of BUN
timeFrame: At 12-weeks
measure: Ratio of Urine Protein/Urine Creatinine
timeFrame: At baseline
measure: Ratio of Urine Protein/Urine Creatinine
timeFrame: At 4-weeks
measure: Ratio of Urine Protein/Urine Creatinine
timeFrame: At 8-weeks
measure: Ratio of Urine Protein/Urine Creatinine
timeFrame: At 12-weeks
measure: Value of GOT
timeFrame: At baseline
measure: Value of GOT
timeFrame: At 4-weeks
measure: Value of GOT
timeFrame: At 8-weeks
measure: Value of GOT
timeFrame: At 12-weeks
measure: Value of GPT
timeFrame: At baseline
measure: Value of GPT
timeFrame: At 4-weeks
measure: Value of GPT
timeFrame: At 8-weeks
measure: Value of GPT
timeFrame: At 12-weeks
Other outcomes:
Locations:
city: Taipei
country: Taiwan
facility: Taipei Medical University
Study officials:
affiliation: Taipei Medical University Hospital
name: PO-HSUAN SU, MD
role: PRINCIPAL_INVESTIGATOR
References: