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Efficacy and Safety Evaluation of the Traditional Chinese Medicine Treatment 'Fu Pi Shen, Hua Yu Shi' in Delaying the Progression of Chronic Renal Failure

Efficacy and Safety Evaluation of the Traditional Chinese Medicine Treatment 'Fu Pi Shen, Hua Yu Shi' in Delaying the Progression of Chronic Renal Failure

Status
Recruiting
Phases
Unknown
Study type
Interventional
Source
ITMCTR
Registry ID
ITMCTR2023000066
Enrollment
Unknown
Registered
2023-12-05
Start date
2020-01-02
Completion date
Unknown
Last updated
2023-12-18

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

Conditions

Chronic kidney disease (CKD)

Interventions

Basic treatment + Zhi Xiong Tong Luo Capsules combined with Ten-Ingredient Kidney Detoxification Solution:In addition to the basic treatment according to Western medical standards, Zhi Xiong Tong Luo
Participating Qi and Nourishing Kidney Granules Combined with Ten-Ingredient Kidney Detoxifying Solution: In addition to the basic treatment based on Western medical standards, the patient is advised
Basic treatment according to Western medicine standards:Western medical basic treatment

Sponsors

Chongqing Traditional Chinese Medicine Hospital
Lead Sponsor

Eligibility

Sex/Gender
All
Age
18 Years to 75 Years

Inclusion criteria

Inclusion criteria: 1) Patients diagnosed with chronic kidney disease. 2) Age = 18 years to = 75 years, both genders. 3) CKD stage 3-5, with renal function eGFR > 15 to = 60 ml/min/1.73m2 (calculated using the CKD-EPI equation), and no need for blood purification treatment. 4) Signed informed consent form.

Exclusion criteria

Exclusion criteria: 1) Abnormal liver function (ALT, AST greater than 2.5 times the upper limit of normal). 2) Patients with a recent history (within three months) of severe cardiovascular diseases such as myocardial infarction, coronary artery bypass grafting, or ischemic heart disease with heart failure (functional class III-IV, NYHA classification). 3) Patients with a recent history (within three months) of severe cerebrovascular diseases such as stroke, or significant neurological functional impairment after stroke. 4) Patients with a recent history (within three months) of active gastrointestinal bleeding. 5) Known severe thrombocytopenia (PLT 5.5mmol/L. 7) History of allergy to the components of the investigational drug. 8) Pregnant or lactating women. 9) Patients scheduled for urgent hemodialysis treatment. 10) Currently using corticosteroids, non-steroidal anti-inflammatory drugs, or immunosuppressive agents. 11) Other diseases or conditions, as determined by the investigator, that may reduce the likelihood of enrollment or complicate the study, such as mental illness, frequent changes in living and working environment leading to loss to follow-up.

Design outcomes

Primary

MeasureTime frame
Composite Endpoints:GFR is not decreased, with an increase of less than 10%; blood creatinine is not increased, or decreased by less than 10%; all-cause mortality;

Secondary

MeasureTime frame
Changes in traditional Chinese medicine syndrome efficacy score;Kidney function;

Countries

China

Contacts

Public ContactXiong Weijian

Chongqing Traditional Chinese Medicine Hospital

2270275469@qq.com13628371818

Outcome results

None listed

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