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A multicenter, double-blind, randomized, placebo-controlled clinical study on the treatment of chronic kidney disease stage 3 with Shenqi Shenshuai mixture

A multicenter, double-blind, randomized, placebo-controlled clinical study on the treatment of chronic kidney disease stage 3 with Shenqi Shenshuai mixture

Status
Recruiting
Phases
Unknown
Study type
Interventional
Source
ITMCTR
Registry ID
ITMCTR2026000190
Enrollment
Unknown
Registered
2026-01-28
Start date
2025-09-30
Completion date
Unknown
Last updated
2026-02-02

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

Conditions

Chronic kidney disease

Interventions

High dose treatment group:Shenqi Shenshuai mixture
Low dose treatment group:10% concentration of Shenqi Shenshuai mixture

Sponsors

Wuhan NO.1 Hospital
Lead Sponsor

Eligibility

Sex/Gender
All
Age
18 Years to 80 Years

Inclusion criteria

Inclusion criteria: (1) Meets the diagnostic criteria for stage 3 chronic kidney disease; (2) Traditional Chinese medicine syndrome differentiation belongs to spleen kidney qi deficiency combined with blood stasis and dampness turbidity syndrome; (3) Gender not limited, age greater than or equal to 18 years old and less than 80 years old; (4) Not receiving dialysis treatment; (5) Sign the informed consent form, with complete general and clinical information; (6) Be able to comply with the research procedures specified in the protocol.

Exclusion criteria

Exclusion criteria: (1) Patients with acute exacerbation of chronic renal failure; (2) Patients with diabetes; (3) Patients with large amounts of proteinuria (24-hour urine protein quantification = 3.5g or total urine protein/creatinine = 3.5g/g); (4) Low density lipoprotein (LDL) = twice the normal reference range; (5) Poor control of hypertension (using standard measurement methods under quiet and awake conditions, with at least 3 non same day systolic blood pressure = 160mmHg and/or diastolic blood pressure = 100 mmHg, or at least 1 blood pressure SBP = 180mmHg and/or DBP = 110 mmHg); (6) During the medication period, patients who have used Chinese herbal medicine or drugs indicated on the drug instructions as having an impact on kidney function; (7) Patients who are pregnant, breastfeeding, or have pregnancy plans; (8) Merge patients with serious complications such as severe infections, severe cardiovascular and cerebrovascular diseases, gastrointestinal bleeding, and malignant tumors; (9) Patients with a history of mental illness or poor compliance who cannot be treated according to the plan; (10) Patients who participate in other clinical trials during medication. (11) The researchers believe that there are any other patients who are not suitable to participate in this trial.

Design outcomes

Primary

MeasureTime frame
Annual average decline rate of glomerular filtration rate (eGFR);

Secondary

MeasureTime frame
Changes in clinical efficacy score;TCM syndrome score;TCM main syndrome score;secondary syndrome score;total syndrome score;hemoglobin;Total Protein;albumin;serum creatinine;Blood Urea Nitrogen;serum kalium;serum calcium;serum phosphorus;Cystatin C;cholesterol;triglyceride;High density lipoprotein;Low density lipoprotein;Serum ferritin;C-reactive protein;IL-1ß;IL-6;TNF-a;IL-10;

Countries

China

Contacts

Public ContactXiong Fei

Wuhan NO.1 Hospital

xiongf23@sina.com027-85332356

Outcome results

None listed

Source: ITMCTR (via WHO ICTRP) · Data processed: Feb 7, 2026