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A Clinical Study Evaluating the Protective Effects of Compound Glycyrrhizin Tablets on Cardiovascular and Cerebrovascular Health in Patients with Uremia

A Prospective Randomized Controlled Trial on the Effects of Compound Glycyrrhizin Tablets on Cardiovascular and Cerebrovascular Events in Maintenance Dialysis Patients (Including Hemodialysis and Peritoneal Dialysis)

Status
Active, not recruiting
Phases
Unknown
Study type
Interventional
Source
ChiCTR
Registry ID
ChiCTR2600125702
Enrollment
Unknown
Registered
2026-05-29
Start date
2026-06-01
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

End-Stage Renal Disease(ESRD)

Interventions

Control Group:Standard dialysis therapy and complication management without study drug (placebo control)
Treatment Group:Oral compound glycyrrhizin tablets, three times daily, 3 tablets (75mg) each time, total daily dose 225mg, continuous use for 24 months

Sponsors

Huashan Hospital, Fudan University
Lead Sponsor

Eligibility

Sex/Gender
All
Age
18 Years to No maximum

Inclusion criteria

Inclusion criteria: 1. Gender is not limited, age > 18 years; 2. Diagnosed with ESRD and receiving regular maintenance dialysis therapy (including hemodialysis or peritoneal dialysis) for =6 months; 3. Presence of pruritus caused by eczema or dermatitis; 4. No antibiotic use within 2 weeks prior to enrollment, and able to maintain a relatively regular diet; 5. No history of nephrotic syndrome or cholestasis (these patients may have abnormal 11ß-hydroxysteroid dehydrogenase activity).

Exclusion criteria

Exclusion criteria: 1. Confirmed history of stroke (cerebral infarction, cerebral hemorrhage) or other severe brain diseases (e.g., brain tumor, severe traumatic brain injury, epilepsy); 2. Diagnosed with central nervous system degenerative diseases such as dementia, Parkinson's disease, or multiple sclerosis; 3. Presence of severe mental or cognitive impairment making it impossible to cooperate with study-related assessments; 4. Recent use of probiotics; 5. Presence of gastrointestinal diseases that severely affect absorption or gut microbiota (e.g., inflammatory bowel disease, chronic diarrhea, short bowel syndrome); 6. Diagnosed with an uncured malignant tumor within the past 5 years; 7. Currently participating in other interventional clinical trials; 8. Refusal to sign the informed consent form or difficulty in cooperating with the study procedures.

Design outcomes

Primary

MeasureTime frame
Time to First Major Adverse Cardiovascular and Cerebrovascular Event (MACCE);Radiological Progression of Cerebral Small Vessel Disease (CSVD);

Secondary

MeasureTime frame
Plasma Trimethylamine N-oxide (TMAO) Concentration;Gut Microbiota Composition and Abundance;

Countries

China

Contacts

Public ContactXue Jun

Huashan Hospital, Fudan University

xuejun@fudan.edu.cn+86 21 66895028

Outcome results

None listed

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