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NCT Number: NCT07543809

Efficacy of XYZ for Withdrawal Syndrome

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.

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Key information

Conditions

Substance Withdrawal Syndrome Chemically-Induced Disorders Mental Disorders Substance-Related Disorders

Age range

18 year–60 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Chongqing Jiangbei Hospital of Traditional Chinese Medicine

Chongqing, Chongqing Municipality, 40020, China

About this study

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).

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • 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

Exclusion criteria

  • 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

Treatment and study plan

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.

Routine care

Other

Routine clinical care including diet guidance, psychological counseling, and sleep hygiene management, without traditional Chinese medicine intervention.

Primary outcomes

  1. Improvement of Withdrawal Syndrome Symptoms

    Time frame: Change from baseline at 3 months

    Evaluated using four standardized scales at baseline and after 3 months of intervention:

    • TCM Syndrome Score (range: 0-9 points; lower scores indicate fewer withdrawal symptoms, i.e., better outcome).
    • Protracted Withdrawal Symptoms Scale (range: 0-80 points; lower scores indicate fewer withdrawal symptoms, i.e., better outcome).
    • Visual Analog Scale (VAS) for Drug Craving (range: 0-10 points; lower scores indicate less drug craving, i.e., better outcome).
    • 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 outcomes

  1. Serum Neurotransmitter Levels

    Time frame: 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.

  2. Serum Inflammatory Factor Levels

    Time frame: 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.

  3. Quality of Life Score

    Time frame: 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).

Sponsors and collaborators

Lead sponsor

Chongqing Jiangbei Hospital of Traditional Chinese Medicine

Other Gov

Collaborators

  • Chongqing University of Chinese Medicine

Registry information

Official study title

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

Acronym: TZYT-WS

Important dates

Study start
2024
Primary completion
2024
Study completion
2024
First posted
Apr 22, 2026
Registry last updated
Apr 27, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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