Efficacy of XYZ for Withdrawal Syndrome

This is a randomized controlled clinical trial to explore the efficacy and mechanism of Tiaozhong-Yiqi Decoction (TZYD) in treating substance withdrawal syndrome, combining network pharmacology analysis and clinical validation. A total of 80 patients meeting the diagnostic criteria for withdrawal syndrome were enrolled and randomly divided into two groups: the TZYD intervention group (n=40) received Tiaozhong-Yiqi Decoction 200mL twice daily for 3 consecutive months, combined with routine care; the control group (n=40) received only routine care (diet guidance, psychological counseling, sleep management). The primary outcome was the improvement of withdrawal syndrome symptoms, evaluated by a standardized clinical scale before and after treatment. Secondary outcomes included changes in serum neurotransmitters (dopamine, norepinephrine, 5-hydroxytryptamine), inflammatory factors (IL-6, IL-1β, TNF-α), brain-derived neurotrophic factor (BDNF), and quality of life scores (QOL-DA V2.0). This study aims to provide clinical evidence and a theoretical basis for the application of Tiaozhong-Yiqi Decoction in the treatment of withdrawal syndrome, and to explore its potential regulatory mechanism on the neuroendocrine and immune systems.

NCT Number	NCT07543809
Lead Sponsor	Chongqing Jiangbei Hospital of Traditional Chinese Medicine Collaborators: Chongqing University of Chinese Medicine
Conditions	Substance Withdrawal Syndrome
Enrollment	80 participants
Start Date	2024-05-01
Primary Completion	2024-08-31 (estimated)
Study Completion	2024-08-31 (estimated)
Updated on ClinicalTrials.gov	2026-04-27