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Efficacy Observation and Mechanism Study of Shouhui Tongbian Capsule in Regulating Intestinal Flora Metabolites to Attenuate the Progression of Renal Function in Chronic Kidney Disease Stages 3-5

Efficacy Observation and Mechanism Study of Shouhui Tongbian Capsule in Regulating Intestinal Flora Metabolites to Attenuate the Progression of Renal Function in Chronic Kidney Disease Stages 3-5

Status
Active, not recruiting
Phases
Phase 4
Study type
Interventional
Source
ChiCTR
Registry ID
ChiCTR2600120298
Enrollment
Unknown
Registered
2026-03-11
Start date
2026-03-11
Completion date
Unknown
Last updated
2026-03-16

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

Conditions

Chronic Kidney Disease

Interventions

Treatment Group:Basic Treatment + Shouhui Tongbian Capsule
Control Group:Basic Treatment

Sponsors

Affiliated Hospital of Nanjing University of Chinese Medicine
Lead Sponsor

Eligibility

Sex/Gender
All
Age
18 Years to 80 Years

Inclusion criteria

Inclusion criteria: 1. Diagnosed with CKD stages 3-5 according to the KDIGO guidelines; 2. Aged between 18 and 80 years, regardless of gender; 3. Adequate control of conditions such as infection, acidosis, electrolyte disturbances, hypertension, and hyperlipidemia; 4. Voluntary participation in this study with signed informed consent.

Exclusion criteria

Exclusion criteria: 1. Chronic kidney disease caused by definite secondary factors, such as lupus nephritis, Henoch-Schönlein purpura nephritis, renal damage due to systemic small-vessel vasculitis, or myeloma nephropathy. 2. Acute kidney injury caused by various reasons. 3. Use of medications affecting intestinal flora (e.g., antibiotics or probiotics) within the past month. 4. Gastrointestinal symptoms such as abdominal pain or diarrhea (stool frequency >= 3 times/day, watery stools) within the past 2 weeks. 5. History of abdominal surgery (except appendectomy), or any intestinal disease or neurological disorder causing defecation abnormalities, such as ulcerative colitis, irritable bowel syndrome, multiple sclerosis, or spinal cord injury. 6. Combined with liver dysfunction (ALT or AST >= 31 U/L), or a history of liver disease, or a history of liver injury or family history associated with Polygonum multiflorum preparations. 7. Complicated with consciousness disorders, acute infections, severe cardiopulmonary or hematopoietic system diseases, severe malnutrition, malignant tumors, or any other severe disease affecting survival. 8. Presence of primary bone metabolic diseases, primary parathyroid diseases, or history of parathyroid surgery, kidney transplantation, or other conditions that may interfere with the evaluation of efficacy indicators. 9. Psychiatric disorders that preclude cooperation, lactation, or pregnancy.

Design outcomes

Primary

MeasureTime frame
glomerular filtration rate;

Secondary

MeasureTime frame
Serum creatinine;Serum urea nitrogen;Serum uric acid;Serum cystatin C;Hemoglobin;

Countries

China

Contacts

Public ContactZhou Enchao

Nanjing University of Chinese Medicine

zhouenchao@njucm.edu.cn+86 138 5157 2603

Outcome results

None listed

Source: ChiCTR (via WHO ICTRP) · Data processed: Mar 20, 2026