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Clinical efficacy of Bupi Yishen Formula in the intervention of sarcopenia in chronic kidney disease and its characteristics of serum amino acid metabolism

Clinical efficacy of Bupi Yishen Formula in the intervention of sarcopenia in chronic kidney disease and its characteristics of serum amino acid metabolism

Status
Active, not recruiting
Phases
Unknown
Study type
Observational
Source
ITMCTR
Registry ID
ITMCTR2026001259
Enrollment
Unknown
Registered
2026-05-18
Start date
2026-05-18
Completion date
Unknown
Last updated
2026-06-01

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

Conditions

sarcopenia in chronic kidney disease

Interventions

Bupi Yishen formula group:Standard treatment for chronic kidney, oral Bupi Yishen formula
No Bupi Yishen formula group:Standard treatment for chronic kidney disease
not taking Bupi Yishen formula

Sponsors

The Second Clinical College, Guangzhou University of Chinese Medicine (Guangdong Provincial Hospital of Chinese Medicine)
Lead Sponsor

Eligibility

Sex/Gender
All
Age
18 Years to 85 Years

Inclusion criteria

Inclusion criteria: (1) Age = 18 years old; (2) Derived from the relevant cohorts of Guangdong Provincial Hospital of Traditional Chinese Medicine or Shenzhen Luohu District Hospital of Traditional Chinese Medicine and meeting the diagnostic criteria for chronic kidney disease; (3) Can be diagnosed as sarcopenia based on the existing data in the cohort according to the AWGS 2025 standard; (4) Have relatively complete baseline data and clinical data at least at one follow-up time point; (5) Have clear records of traditional Chinese medicine prescriptions, allowing determination of whether there is exposure to the Bupi Yishen formula; (6) Have blood and/or fecal samples in the biobank that match the clinical data and are suitable for the tests in this study; (7) Have signed the informed consent form, agreeing to the use of clinical data and biological samples for related scientific research.

Exclusion criteria

Exclusion criteria: (1) Patients with acute kidney injury or significant acute fluctuations in renal function during the observation period; (2) Patients who had already started dialysis treatment at baseline or initiated renal replacement therapy within a short period; (3) Patients with malignant tumors, severe liver function impairment, severe heart failure, severe respiratory insufficiency, or other diseases that could significantly affect nutritional status or metabolic levels; (4) Patients with endocrine diseases such as hyperthyroidism or Cushing's syndrome that could significantly affect muscle metabolism; (5) Patients with neuromuscular system diseases, long-term bedridden status, limb disabilities, or severe bone and joint diseases that could clearly affect the determination of sarcopenia or motor function; (6) Patients in the active stage of systemic connective tissue disease requiring high-dose immunosuppressive therapy; (7) Patients with incomplete records of traditional Chinese medicine prescriptions, making it impossible to clearly determine the exposure to Bupi Yishen formula; (8) Patients with severely incomplete clinical data, making it impossible to complete the comparison of primary indicators; (9) Patients with insufficient blood or fecal sample volume, improper storage conditions, or repeated freezing and thawing.

Design outcomes

Primary

MeasureTime frame
appendicular skeletal muscle mass index;

Secondary

MeasureTime frame
grip strength;TCM syndrome score;Hemoglobin;albumin;urea nitrogen;serum creatinine;C-reactive protein;Metabolomic Analysis of Amino Acids in Blood;Metabolomic Analysis of Amino Acids in Feces;

Countries

China

Contacts

Public ContactFuhua Lu

The Second Clinical College, Guangzhou University of Chinese Medicine (Guangdong Provincial Hospital of Chinese Medicine)

lfh0307@126.com13826051370

Outcome results

None listed

Source: ITMCTR (via WHO ICTRP) · Data processed: Jun 11, 2026