Substance Withdrawal Syndrome
Conditions
Keywords
Tiaozhong-Yiqi Decoction, Substance Withdrawal Syndrome, Randomized Controlled Trial, Network Pharmacology, Traditional Chinese Medicine
Brief 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.
Detailed description
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).
Interventions
OTHERTiaozhong-Yiqi Decoction
Traditional Chinese medicine decoction. 200 mL per dose, orally twice daily for 3 consecutive months, for the treatment of substance withdrawal syndrome.
OTHERroutine care
Routine clinical care including diet guidance, psychological counseling, and sleep hygiene management, without traditional Chinese medicine intervention.
Sponsors
Chongqing Jiangbei Hospital of Traditional Chinese Medicine
Chongqing University of Chinese Medicine
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE
Masking description
Open-label study, no blinding applied to participants, investigators, or outcome assessors, due to the nature of traditional Chinese medicine decoction intervention.
Intervention model description
Two-arm parallel randomized controlled trial, with participants assigned to either Tiaozhong-Yiqi Decoction intervention group or routine care control group in a 1:1 ratio.
Eligibility
Sex/Gender
ALL
Age
18 Years to 60 Years
Healthy volunteers
No
Inclusion criteria
1. 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 5. Good compliance, able to complete follow-up and all evaluations
Exclusion criteria
1. Combined with severe organic diseases (heart, liver, kidney, brain, etc.) or malignant tumors 2. Combined with other mental illnesses besides substance withdrawal syndrome 3. Allergic to any component of Tiaozhong-Yiqi Decoction 4. Pregnant or lactating women 5. Poor compliance, unable to complete the study
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Improvement of Withdrawal Syndrome Symptoms | 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). |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Serum Neurotransmitter Levels | Change from baseline at 3 months | Changes in serum dopamine (DA), norepinephrine (NE), and 5-hydroxytryptamine (5-HT) levels. Higher levels of these neurotransmitters indicate better improvement in neurochemical function. |
| Serum Inflammatory Factor Levels | Change from baseline at 3 months | Changes in serum interleukin-6 (IL-6), interleukin-1β (IL-1β), and tumor necrosis factor-α (TNF-α) levels. Lower levels of these inflammatory factors indicate better anti-inflammatory effects. |
| Quality of Life Score | Change from baseline at 3 months | Evaluated by the Quality of Life Scale for Addicts (QOL-DA V2.0) at baseline and after 3 months of intervention. The scale total score ranges from 28 to 140 points, with higher scores indicating better quality of life (better outcome). |
Countries
China
Outcome results
None listed