Clinical Research Directory

Tiaozhong-Yiqi-Tang for Substance Withdrawal Syndrome: A Randomized Controlled Clinical Trial

Sponsor: Chongqing Jiangbei Hospital of Traditional Chinese Medicine

Summary

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.

Official title: Efficacy and Mechanism of Tiaozhong-Yiqi-Tang in the Treatment of Substance Withdrawal Syndrome Based on Network Pharmacology Analysis and Prospective Clinical Validation

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