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

Category Primary study
Registry of TrialsITMCTR
Year 2023
INTERVENTION: 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; CONDITION: Chronic kidney disease (CKD) and Depression PRIMARY OUTCOME: Hamilton Depression Rating Scale, Mental State Examination Scale, Pittsburgh Sleep Quality Index, Epworth Sleepiness Scale, Monocyte, Beck Depression Inventory.; SECONDARY OUTCOME: 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; 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%.
Epistemonikos ID: 3ad59d2515b207c5defe65e53839c04461a793c6
First added on: Aug 28, 2024