Tiaozhong-Yiqi Decoction RCT for Substance Withdrawal, 80 Patients
Summary
A randomized controlled clinical trial registered on ClinicalTrials.gov (NCT07543809) is evaluating Tiaozhong-Yiqi Decoction (TZYD) for treating substance withdrawal syndrome in 80 patients. The intervention group (n=40) receives 200mL TZYD twice daily for 3 months plus routine care; the control group (n=40) receives routine care only. Primary outcome measures withdrawal syndrome symptom improvement via standardized clinical scale; secondary outcomes include serum neurotransmitter levels (dopamine, norepinephrine, 5-hydroxytryptamine), inflammatory factors (IL-6, IL-1β, TNF-α), BDNF, and quality of life scores (QOL-DA V2.0). The study combines network pharmacology analysis with clinical validation to explore TZYD's potential regulatory mechanism on neuroendocrine and immune systems.
“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).”
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What changed
A new clinical trial registry entry was recorded for a randomized controlled study (NCT07543809) investigating Tiaozhong-Yiqi Decoction in patients with substance withdrawal syndrome. Eighty patients were enrolled and randomized 1:1 to receive TZYD 200mL twice daily for 3 months combined with routine care, versus routine care alone (diet guidance, psychological counseling, sleep management). The trial will assess symptom improvement as primary outcome and biochemical markers including neurotransmitters, inflammatory cytokines, and BDNF as secondary outcomes.
For compliance professionals and healthcare researchers, this registry entry provides early visibility into an investigational Traditional Chinese Medicine intervention entering clinical validation. Sponsors of competing or complementary withdrawal syndrome therapies should note the specific inclusion criteria and outcome measures used. The study design incorporates both subjective clinical scales and objective serum biomarkers, which may inform future protocol design for similar investigations.
Archived snapshot
Apr 23, 2026GovPing captured this document from the original source. If the source has since changed or been removed, this is the text as it existed at that time.
Tiaozhong-Yiqi-Tang for Substance Withdrawal Syndrome: A Randomized Controlled Clinical Trial
N/A NCT07543809 Kind: NA Apr 22, 2026
Abstract
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.
Conditions: Substance Withdrawal Syndrome
Interventions: Tiaozhong-Yiqi Decoction, routine care
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