To evaluate the clinical efficacy and safety of Bailing capsule in the treatment of patients with chronic kidney disease stage 2-4 (CKD stage 2-4)

Status

Active, not recruiting

Phases

Phase 2

Study type

Observational

Source

ITMCTR

Registry ID

ITMCTR2024000026

Enrollment

Unknown

Registered

2024-03-13

Start date

2023-08-01

Completion date

Unknown

Last updated

2024-08-19

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

Conditions

Stage 2 through 4 chronic kidney disease

Interventions

Basic treatment group:Patients who were not treated with Bailing capsule (including patients who were not treated with other cordyceps sinensis

Bailing capsule group:Patients who received Bailing capsules (without other cordyceps sinensis patent Chinese medicine)

Eligibility

Sex/Gender

All

Age

18 Years to No maximum

Inclusion criteria

Inclusion criteria: 1. The initial diagnosis met the western diagnostic criteria for chronic kidney disease: chronic kidney structure and dysfunction or decreased glomerular filtration rate (GFR) caused by various reasons for more than 3 months; Renal injury included: (1) proteinuria: urinary albumin excretion rate (UAER) = 30 mg/24 h; Urinary albumin-to-creatinine ratio (ACR) = 30 mg/g (=3 mg/mmol), (2) abnormal urinary sediment, (3) electrolyte and other abnormalities caused by renal tubular dysfunction, (4) histological abnormalities, (5) abnormal imaging examination, (5) abnormal renal function. (6) History of renal transplantation. 2. CKD stage 2 (GFR=60 ml/min/1.73 m2, and GFR < 90ml/min/1.73 m2) or CKD stage 3 (GFR=30 ml/min/1.73 m2, GFR=30 ml/min/1.73 m2; GFR < 60ml/min/1.73 m2) or CKD stage 4 (GFR=15 ml/min/1.73 m2 and GFR < 30ml/min/1.73 m2); (3) The first visit time is 2017-1-1 to 2022-6-30, and the age is 18 years old and above.

Exclusion criteria

Exclusion criteria: 1. Patients who used other Chinese patent medicine of cordyceps sinensis from 2017-1-1 to 2022-6-30; (2) patients who underwent dialysis less than 3 months after the first diagnosis of CKD2-4 or CKD Patients with extended; 3. Diagnose patients not associated with chronic kidney disease or chronic renal insufficiency. 4. Inability to judge the efficacy or incomplete data affecting the efficacy or safety judgment.

Design outcomes

Primary

Measure	Time frame
Time to first occurrence of the composite end point;	—

Secondary

Measure	Time frame
The usage of Bailing capsule during the study period, including the dosage and duration, etc;The proportion of patients with a =30% decrease in the urinary albumin-to-creatinine ratio (UACR);The complication rate of chronic kidney disease;All-cause mortality;	—

Countries

China

Contacts

Public ContactBicheng Liu

Zhongda Hospital affiliated to Southeast University

liubc64@163.com+86 180 0158 0838

Outcome results

None listed

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