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| ID | Type | Description | Link |
|---|---|---|---|
| 2024ZY023993 | Other Identifier | Ethics Committee of Chongqing Jiangbei Hospital of Traditional Chinese Medicine |
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| Name | Class |
|---|---|
| Chongqing University of Chinese Medicine | UNKNOWN |
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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.
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).
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| TZYD Intervention Group | Experimental | Participants receive Tiaozhong-Yiqi Decoction 200mL orally twice daily for 3 consecutive months, combined with routine care for substance withdrawal syndrome. |
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| Conventional Care Control Group | Active Comparator | Participants receive only routine care, including diet guidance, psychological counseling, and sleep management, without Tiaozhong-Yiqi Decoction intervention. |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Tiaozhong-Yiqi Decoction | Other | Traditional Chinese medicine decoction. 200 mL per dose, orally twice daily for 3 consecutive months, for the treatment of substance withdrawal syndrome. |
| Measure | Description | Time Frame |
|---|---|---|
| Improvement of Withdrawal Syndrome Symptoms | Evaluated using four standardized scales at baseline and after 3 months of intervention:
| Change from baseline at 3 months |
| Measure | Description | Time Frame |
|---|---|---|
| Serum Neurotransmitter Levels | Changes in serum dopamine (DA), norepinephrine (NE), and 5-hydroxytryptamine (5-HT) levels. Higher levels of these neurotransmitters indicate better improvement in neurochemical function. | Change from baseline at 3 months |
| Serum Inflammatory Factor Levels |
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Inclusion Criteria:
Exclusion Criteria:
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Chongqing Jiangbei Hospital of Traditional Chinese Medicine | Chongqing | Chongqing Municipality | 40020 | China |
The individual participant data will not be shared, as this is a single-center, investigator-initiated clinical trial with a small sample size, and the data is protected by patient privacy and institutional confidentiality agreements.
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| ID | Term |
|---|---|
| D013375 | Substance Withdrawal Syndrome |
| ID | Term |
|---|---|
| D019966 | Substance-Related Disorders |
| D064419 | Chemically-Induced Disorders |
| D001523 | Mental Disorders |
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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.
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Open-label study, no blinding applied to participants, investigators, or outcome assessors, due to the nature of traditional Chinese medicine decoction intervention.
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| routine care | Other | Routine clinical care including diet guidance, psychological counseling, and sleep hygiene management, without traditional Chinese medicine intervention. |
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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. |
| Change from baseline at 3 months |
| Quality of Life Score | 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). | Change from baseline at 3 months |