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Clinical Research Program on the Regulation of Neuroimmune Interaction Mechanism and Improvement of Depression in CKD with Modified Chaihu Longgu Muli Decoction

Clinical Research Program on the Regulation of Neuroimmune Interaction Mechanism and Improvement of Depression in CKD with Modified Chaihu Longgu Muli Decoction

Status
Recruiting
Phases
Unknown
Study type
Interventional
Source
ITMCTR
Registry ID
ITMCTR2023000068
Enrollment
Unknown
Registered
2023-12-05
Start date
2023-12-07
Completion date
Unknown
Last updated
2023-12-18

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

Conditions

Chronic kidney disease (CKD) and Depression

Interventions

CKD combined with depression Western medicine group:Basic therapy for CKD + Escitalopram
CKD combined with depression Chinese herbal medicine group:Basic therapy for CKD + Chaihu Longgu Muli decoction with modified ingredients

Sponsors

Chongqing Traditional Chinese Medicine Hospital
Lead Sponsor

Eligibility

Sex/Gender
All
Age
18 Years to 70 Years

Inclusion criteria

Inclusion criteria: 1. The diagnostic criteria for CKD are based on the "KDIGO-CKD Guidelines" published by the International Kidney Disease Organization in 2012. CKD staging is determined using the eGFR calculation formula (China's MDRD formula) (Part I of the trial). The diagnostic criteria for depressive disorders comply with the diagnostic criteria for depressive disorders in the Chinese Classification and Diagnostic Criteria for Mental Disorders (CCMD-3) (Part II). 2. Patients voluntarily participate in the study and provide informed consent by signing the informed consent form. 3. Patients are able to understand the research procedures and comply with them throughout the study duration. 4. Age range between 18-70 years. 5. During the screening period (within 30 days after signing the informed consent), the GFR fluctuation range in the past 3 months is =30%.

Exclusion criteria

Exclusion criteria: 1. Unable to provide informed consent. 2. Pregnant or lactating women. 3. NYHA III or IV heart failure, which means having underlying heart disease, significant limitation in physical activity, and experiencing fatigue, palpitations, dyspnea, or angina symptoms even at rest or with minimal exertion. 4. Liver dysfunction or cirrhosis; HIV infection or AIDS. 5. Underwent chemotherapy or alkylating agent treatment for malignant tumors in the past 2 years. 6. Received immunosuppressive therapy for primary kidney disease or systemic diseases in the past 3 months. 7. Previously diagnosed with genetic kidney diseases such as polycystic kidney disease. 8. Presence of infectious diseases or use of anti-infective treatment in the past 2 weeks. 9. Severe depression/suicidal tendencies, as there may be safety concerns with only herbal intervention. 10. Suspected or known allergy to any component of traditional Chinese medicine or escitalopram.

Design outcomes

Primary

MeasureTime frame
Hamilton Depression Rating Scale, Mental State Examination Scale, Pittsburgh Sleep Quality Index, Epworth Sleepiness Scale, Monocyte, Beck Depression Inventory.;

Secondary

MeasureTime frame
TCM syndrome scores;IFN-?\IL-1ß\IL-1RA\IL-2\IL-4\IL-5\IL-6\IL-7\IL-8\IL-9\IL-10\IL-12 p70\IL-13\IL-15\IL-17A\IL-18;G-CSF\GM-CSF\CD40L\MCP-1\MIP-1ß\TNF-a?TNF-ß\sTNFR2\CCL11\CXCL4\CXCL7\CXCL10;Montgomery-Åsberg Depression Rating Scale\Clinical Global Impression Scale\Quality of Life Assessment Scale;CD68\CD80\CD206\CD4\CCR7\CD45RA\CXCR5\FOXP3\CD25\CD3\CD4\TCRaß;

Countries

China

Contacts

Public ContactLI Fan

Chongqing Traditional Chinese Medicine Hospital

76570739@qq.com13996275602

Outcome results

None listed

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