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Shenshuai Guanchang Decoction in the Treatment of Non-dialysis Patients with Chronic Kidney Disease Stage 4-5 of Spleen and Kidney Deficiency, Blood Stasis and Dampness Turbidity:A Randomized Controlled Trial

Clinical Study of Shenshuai Guanchang Decoction on Improving Intestinal Barrier Permeability in Patients with CKD4-5 by Down-regulating Intestinal Uremic Toxin

Status
Active, not recruiting
Phases
Unknown
Study type
Interventional
Source
ITMCTR
Registry ID
ITMCTR2025002570
Enrollment
Unknown
Registered
2025-12-27
Start date
2024-02-04
Completion date
Unknown
Last updated
2026-01-12

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

Conditions

Chronic kidney disease stage 4-5 (CKD4-5)

Interventions

Control group:Basic treatment
Experimental Group:Basic treatment combined with conventional Chinese herbal enema

Sponsors

Wangjing Hospital China Academy of Chinese Medical Sciences
Lead Sponsor

Eligibility

Sex/Gender
All
Age
18 Years to 75 Years

Inclusion criteria

Inclusion criteria: 1. In line with the diagnostic criteria of chronic kidney disease stage 4-5 Western medicine and spleen and kidney deficiency, blood stasis and dampness syndrome of TCM syndrome differentiation standard ; 2. According to the literature ('systematic evaluation of traditional Chinese medicine compound retention enema in the treatment of chronic renal failure'), the age was set to be between 18 and 75 years old ( including 18 and 75 years old ) ; 3. patients without renal replacement therapy, conservative treatment ; 4. Inpatients with good compliance and signed informed consent.

Exclusion criteria

Exclusion criteria: 1. Patients with chronic kidney disease who had undergone long-term maintenance hemodialysis ; 2. Chronic kidney disease in the presence of pleural effusion, ascites, severe anemia, severe malnutrition, urinary protein more than 3.5g/d ; 3. Patients with emergency dialysis indications such as hyperkalemia, acidosis and uremic encephalopathy that were difficult to correct ; 4. Patients with acute infection, acute attack of cardiovascular disease, hypertensive heart disease, hypertrophic cardiomyopathy, valvular heart disease, ventricular aneurysm, hyperthyroidism, severe heart failure, and cardiac function above grade IV in the past 3 months ; 5. Patients currently taking glucocorticoids or immunosuppressive agents ; 6. Patients with severe intestinal diseases who could not tolerate enema ; 7. Patients with chronic diarrhea and hemorrhoids acute attack, anal fissure, intestinal surgery.

Design outcomes

Primary

MeasureTime frame
TCM symptom score;P-cresol sulfate;Intestinal fatty acid binding protein;

Secondary

MeasureTime frame
cystatin c;beta 2-microglobulin;Serum creatinine;Urea nitrogen;Estimated glomerular filtration rate;

Countries

China

Contacts

Public ContactTongxia Li

Wangjing Hospital China Academy of Chinese Medical Sciences

litongxia0711@126.com15811353504

Outcome results

None listed

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