Efficacy and Mechanism of Tiaozhong-Yiqi-Tang in the Treatment of Substance Withdrawal Syndrome Based on Network Pharmacology Analysis and Prospective Clinical Validation
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 80
- 试验地点
- 1
- 主要终点
- Improvement of Withdrawal Syndrome Symptoms
研究概览
简要总结
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.
详细描述
This study is a single-center, randomized, open-label, parallel-controlled clinical trial conducted at Chongqing Jiangbei Hospital of Traditional Chinese Medicine.
Inclusion criteria: 1. Patients aged 18-60 years old; 2. Meeting the diagnostic criteria for substance withdrawal syndrome; 3. No use of other detoxification drugs or traditional Chinese medicine formulas within 2 weeks before enrollment; 4. Voluntary participation and signed informed consent.
Exclusion criteria: 1. Combined with severe organic diseases (heart, liver, kidney, brain, etc.) or malignant tumors; 2. Combined with other mental illnesses; 3. Allergic to any component of Tiaozhong-Yiqi Decoction; 4. Pregnant or lactating women; 5. Poor compliance unable to complete follow-up.
The intervention period was 3 months, with follow-up at baseline, 1 month, 2 months, and 3 months. All data were collected by trained researchers, and statistical analysis was performed using SPSS software. The study was approved by the Ethics Committee of Chongqing Jiangbei Hospital of Traditional Chinese Medicine (Approval No. 2024-04).
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- None
盲法说明
Open-label study, no blinding applied to participants, investigators, or outcome assessors, due to the nature of traditional Chinese medicine decoction intervention.
入排标准
- 年龄范围
- 18 Years 至 60 Years（Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Aged 18-60 years old
- •Meeting the diagnostic criteria for substance withdrawal syndrome
- •No use of other detoxification drugs or traditional Chinese medicine formulas within 2 weeks before enrollment
- •Voluntary participation and signed informed consent
- •Good compliance, able to complete follow-up and all evaluations
排除标准
- •Combined with severe organic diseases (heart, liver, kidney, brain, etc.) or malignant tumors
- •Combined with other mental illnesses besides substance withdrawal syndrome
- •Allergic to any component of Tiaozhong-Yiqi Decoction
- •Pregnant or lactating women
- •Poor compliance, unable to complete the study
研究组 & 干预措施
TZYD Intervention Group
Participants receive Tiaozhong-Yiqi Decoction 200mL orally twice daily for 3 consecutive months, combined with routine care for substance withdrawal syndrome.
干预措施: Tiaozhong-Yiqi Decoction (Other)
Conventional Care Control Group
Participants receive only routine care, including diet guidance, psychological counseling, and sleep management, without Tiaozhong-Yiqi Decoction intervention.
干预措施: routine care (Other)
结局指标
主要结局
Improvement of Withdrawal Syndrome Symptoms
时间窗: 3 months
Evaluated by a standardized clinical withdrawal syndrome scale at baseline and after 3 months of intervention.
Improvement of Withdrawal Syndrome Symptoms
时间窗: Change from baseline at 3 months
Evaluated using four standardized scales at baseline and after 3 months of intervention: 1. TCM Syndrome Score (range: 0-9 points; lower scores indicate fewer withdrawal symptoms, i.e., better outcome). 2. Protracted Withdrawal Symptoms Scale (range: 0-80 points; lower scores indicate fewer withdrawal symptoms, i.e., better outcome). 3. Visual Analog Scale (VAS) for Drug Craving (range: 0-10 points; lower scores indicate less drug craving, i.e., better outcome). 4. Quality of Life Scale for Addicts (QOL-DA V2.0) (total score range: 28-140 points; higher scores indicate better quality of life, i.e., better outcome).
次要结局
- Serum Neurotransmitter Levels(Baseline and 3 months)
- Serum Inflammatory Factor Levels(Baseline and 3 months)
- Quality of Life Score(3 months)
- Serum Neurotransmitter Levels(Change from baseline at 3 months)
- Serum Inflammatory Factor Levels(Change from baseline at 3 months)
- Quality of Life Score(Change from baseline at 3 months)