Skip to content

A prospective, randomized, blank controlled, single-center study on the effect of Bailing Capsules on immune function in maintenance hemodialysis patients

A prospective, randomized, blank controlled, single-center study on the effect of Bailing Capsules on immune function in maintenance hemodialysis patients

Status
Active, not recruiting
Phases
Unknown
Study type
Interventional
Source
ChiCTR
Registry ID
ChiCTR2300072877
Enrollment
Unknown
Registered
2023-06-27
Start date
2023-07-01
Completion date
Unknown
Last updated
2023-07-02

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

Conditions

maintenance hemodialysis

Interventions

Treatment group:On the basis of routine treatment of maintenance hemodialysis patients, oral Bailing capsules (0.5g/ tablets) are taken 3 times a day, 4 tablets each time for 6 months.
Control group:Routine treatment for maintenance hemodialysis patients without special intervention.

Sponsors

Ren Ji Hospital, Shanghai Jiao Tong University School of Medicine
Lead Sponsor

Eligibility

Sex/Gender
All
Age
18 Years to No maximum

Inclusion criteria

Inclusion criteria: i. Age = 18 years old, regardless of sex ii. Maintenance hemodialysis patients (regular dialysis = 3 months), 3 times per week, 4h/ times iii.Sign the informed consent form.

Exclusion criteria

Exclusion criteria: i. Allergic to Bailing capsule or Cordyceps sinensis ii. Patients who have taken Bailing capsule or other Cordyceps sinensis medicine within 3 months iii. Patients who were treated with immunosuppressive drugs (including glucocorticoids) within 1 month iv. Patients who receive immuno enhancer therapy within 1 month v. Any clinical or laboratory evidence of acute bacterial or viral infection within 2 weeks vi. Patients with an estimated survival time of less than 6 months vii. The following complications exist: systemic autoimmune diseases, active hepatitis (ALT exceeds the normal limit, positive for HBsAg or HCV antibodies), liver failure, severe anemia, cachexia, severe malnutrition, lymphoproliferative diseases, malignant tumors and other underlying diseases that affect immune function. viii. Patients who participate in clinical studies of trial drugs within 28 days, or have randomly visited trial drugs in ongoing clinical studies ix. Pregnant or lactating women x. Any situation considered by the researchers to be unsuitable to participate in this study.

Design outcomes

Primary

MeasureTime frame
CD4/CD8;

Secondary

MeasureTime frame
Expression of TLR and integrin on neutrophils;Expression of TLR and integrin on atypical pro-inflammatory subsets of monocyte(CD14+CD16++);Expression of NKG2D, NKp44 and CD69 on NK cell subsets;Lymphocyte subsets;TCR Vß repertoire;Twelve cytokines;Neutrophils lymphocytes ratio;Platelets lymphocytes ratio;hsCRP;Homocysteine;Incidence of infection and cardio-cerebrovascular events;Neutrophil MPO level;

Countries

China

Contacts

Public ContactGu Leyi

Ren Ji Hospital, Shanghai Jiao Tong University School of Medicine

guleyi@aliyun.com+86 139 1814 8433

Outcome results

None listed

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