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

Chronic Kidney Diseases Clinical Trial

Official title:

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

Clinical Trial Details — Status: Enrolling by invitation

Administrative data

• NCT number: NCT05387187
• Other study ID #: N202204011
• Status: Enrolling by invitation
• Phase: Phase 2/Phase 3
• Start date: May 1, 2022
• Est. completion date: June 20, 2023

Study information

• Verified date: June 2023
• Source: Taipei Medical University Hospital
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Enrolling by invitation
• Enrollment: 40
• Est. completion date: June 20, 2023
• Est. primary completion date: May 31, 2022
• Accepts healthy volunteers: No
• Gender: All
• Age group: 20 Years to 80 Years

Eligibility

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.

Related Conditions & MeSH terms

• Chronic Kidney Diseases
• Kidney Diseases
• Renal Insufficiency, Chronic

Intervention

Drug:
• Pu Yang Wan Wu Tang plus Pentoxifylline
Pu Yang Wan Wu Tang 5g TID Pentoxifylline 100mg TID
• Pentoxifylline
Pentoxifylline 100mg TID

Locations

Country	Name	City	State
Taiwan	Taipei Medical University	Taipei

Sponsors (1)

Lead Sponsor	Collaborator
Taipei Medical University Hospital

Country where clinical trial is conducted

Taiwan, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Value of eGFR		At baseline
Primary	Value of eGFR		At 4-weeks
Primary	Value of eGFR		At 8-weeks
Primary	Value of eGFR		At 12-weeks
Secondary	Value of Creatinine		At baseline
Secondary	Value of Creatinine		At 4-weeks
Secondary	Value of Creatinine		At 8-weeks
Secondary	Value of Creatinine		At 12-weeks
Secondary	Value of BUN		At baseline
Secondary	Value of BUN		At 4-weeks
Secondary	Value of BUN		At 8-weeks
Secondary	Value of BUN		At 12-weeks
Secondary	Ratio of Urine Protein/Urine Creatinine		At baseline
Secondary	Ratio of Urine Protein/Urine Creatinine		At 4-weeks
Secondary	Ratio of Urine Protein/Urine Creatinine		At 8-weeks
Secondary	Ratio of Urine Protein/Urine Creatinine		At 12-weeks
Secondary	Value of GOT		At baseline
Secondary	Value of GOT		At 4-weeks
Secondary	Value of GOT		At 8-weeks
Secondary	Value of GOT		At 12-weeks
Secondary	Value of GPT		At baseline
Secondary	Value of GPT		At 4-weeks
Secondary	Value of GPT		At 8-weeks
Secondary	Value of GPT		At 12-weeks