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

Sponsor
Taipei Medical University Hospital (Other)
Overall Status
Not yet recruiting
CT.gov ID
NCT05387187
Collaborator
(none)
40
Enrollment
2
Arms
12
Anticipated Duration (Months)

Study Details

Study Description

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.

Condition or Disease Intervention/Treatment Phase
Phase 2/Phase 3

Study Design

Study Type:
Interventional
Anticipated Enrollment :
40 participants
Allocation:
Randomized
Intervention Model:
Parallel Assignment
Masking:
Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose:
Treatment
Official Title:
Evaluate the Effect and Safety of Pu Yang Wan Wu Tang and Western Medicine on Chronic Kidney Disease
Anticipated Study Start Date :
Jun 1, 2022
Anticipated Primary Completion Date :
May 31, 2023
Anticipated Study Completion Date :
May 31, 2023

Arms and Interventions

Arm Intervention/Treatment
Experimental: Pu Yang Wan Wu Tang plus Pentoxifylline

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

Drug: Pentoxifylline
Pentoxifylline 100mg TID

Outcome Measures

Primary Outcome Measures

  1. Value of eGFR [At baseline]

  2. Value of eGFR [At 4-weeks]

  3. Value of eGFR [At 8-weeks]

  4. Value of eGFR [At 12-weeks]

Secondary Outcome Measures

  1. Value of Creatinine [At baseline]

  2. Value of Creatinine [At 4-weeks]

  3. Value of Creatinine [At 8-weeks]

  4. Value of Creatinine [At 12-weeks]

  5. Value of BUN [At baseline]

  6. Value of BUN [At 4-weeks]

  7. Value of BUN [At 8-weeks]

  8. Value of BUN [At 12-weeks]

  9. Ratio of Urine Protein/Urine Creatinine [At baseline]

  10. Ratio of Urine Protein/Urine Creatinine [At 4-weeks]

  11. Ratio of Urine Protein/Urine Creatinine [At 8-weeks]

  12. Ratio of Urine Protein/Urine Creatinine [At 12-weeks]

  13. Value of GOT [At baseline]

  14. Value of GOT [At 4-weeks]

  15. Value of GOT [At 8-weeks]

  16. Value of GOT [At 12-weeks]

  17. Value of GPT [At baseline]

  18. Value of GPT [At 4-weeks]

  19. Value of GPT [At 8-weeks]

  20. Value of GPT [At 12-weeks]

Eligibility Criteria

Criteria

Ages Eligible for Study:
20 Years to 80 Years
Sexes Eligible for Study:
All
Accepts Healthy Volunteers:
No
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.

Contacts and Locations

Locations

No locations specified.

Sponsors and Collaborators

  • Taipei Medical University Hospital

Investigators

None specified.

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.
Responsible Party:
Su, Po-Hsuan, Doctor, Taipei Medical University Hospital
ClinicalTrials.gov Identifier:
NCT05387187
Other Study ID Numbers:
  • N202204011
First Posted:
May 24, 2022
Last Update Posted:
May 24, 2022
Last Verified:
May 1, 2022
Studies a U.S. FDA-regulated Drug Product:
No
Studies a U.S. FDA-regulated Device Product:
No
Additional relevant MeSH terms:
Kidney Diseases
Renal Insufficiency, Chronic
Pentoxifylline

Study Results

No Results Posted as of May 24, 2022