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A randomized controlled clinical trial of Bushen Tiaozhong decoction for the treatment of chronic kidney disease stage 4-5 (non-dialysis)

A randomized controlled clinical trial of Bushen Tiaozhong decoction for the treatment of chronic kidney disease stage 4-5 (non-dialysis)

Status
Recruiting
Phases
Unknown
Study type
Interventional
Source
ITMCTR
Registry ID
ITMCTR2025000372
Enrollment
Unknown
Registered
2025-02-20
Start date
2024-11-01
Completion date
Unknown
Last updated
2025-03-03

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

chronic kidney disease

Interventions

test group:Basic therapy and Bushen Tiaozhong granules
control groups:Basic therapy and Bushen Tiaozhong decoction placebo

Sponsors

Xiyuan Hospital of CACMS
Lead Sponsor

Eligibility

Sex/Gender
All
Age
18 Years to 75 Years

Inclusion criteria

Inclusion criteria: (1) Western medicine diagnosis of chronic kidney disease stage 4-5 and no dialysis; (2) Chinese medicine diagnosis is consistent with spleen deficiency and dampness obstruction; (3) Age 18-75 years old gender is not limited; (4) 24h urine protein quantification = 2.0g; (5) Voluntarily accept this study and sign the informed consent form.

Exclusion criteria

Exclusion criteria: rmal reference value) and clinically significant ECG abnormalities. (4) Hypersensitivity to the study drug and allergy; (5) Pregnant and lactating women; (6) Participants in other clinical trials within the last 1 month; (7) Mental or cognitive disorders that prevent subjects from understanding the trial instructions providing informed consent as well as those who are unable to take the medication on time have poor compliance or are unable to adhere to follow-up visits. If the patient is a woman of childbearing age it is necessary to ask carefully whether there is a possibility of pregnancy to ensure that the enrolled patients meet the inclusion and exclusion criteria and to emphasize the need for strict contraceptive measures during the study period.

Design outcomes

Primary

MeasureTime frame
Serum Creatinine ;Estimated Glomerular Filtration Rate;Traditional Chinese Medicine Syndrome Scoring;

Secondary

MeasureTime frame
Cholesterol;T4/T8;Total T and B Cell Count;Serum Albumin;

Countries

China

Contacts

Public ContactYu Dajun

Xiyuan Hospital of CACMS

yudajunfly@126.com13651229860

Outcome results

None listed

Source: ITMCTR (via WHO ICTRP) · Data processed: Feb 4, 2026