Efficacy of XYZ for Withdrawal Syndrome (TZYT-WS)

April 22, 2026 updated by: Chongqing Jiangbei Hospital of Traditional Chinese Medicine

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

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

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).

Study Type

Interventional

Enrollment (Actual)

80

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • China
    • Chongqing Municipality
      • Chongqing, Chongqing Municipality, China, 40020
        • Chongqing Jiangbei Hospital of Traditional Chinese Medicine

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Adult

Accepts Healthy Volunteers

No

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: TZYD Intervention Group
Participants receive Tiaozhong-Yiqi Decoction 200mL orally twice daily for 3 consecutive months, combined with routine care for substance withdrawal syndrome.
Other: Tiaozhong-Yiqi Decoction
Traditional Chinese medicine decoction. 200 mL per dose, orally twice daily for 3 consecutive months, for the treatment of substance withdrawal syndrome.
Active Comparator: Conventional Care Control Group
Participants receive only routine care, including diet guidance, psychological counseling, and sleep management, without Tiaozhong-Yiqi Decoction intervention.
Other: routine care
Routine clinical care including diet guidance, psychological counseling, and sleep hygiene management, without traditional Chinese medicine intervention.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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:

  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).
Change from baseline at 3 months

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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.
Change from baseline at 3 months
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.
Change from baseline at 3 months
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).
Change from baseline at 3 months

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Chongqing Jiangbei Hospital of Traditional Chinese Medicine

Collaborators

Chongqing University of Chinese Medicine

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

May 1, 2024

Primary Completion (Actual)

August 31, 2024

Study Completion (Actual)

August 31, 2024

Study Registration Dates

First Submitted

April 15, 2026

First Submitted That Met QC Criteria

April 15, 2026

First Posted (Actual)

April 22, 2026

Study Record Updates

Last Update Posted (Actual)

April 27, 2026

Last Update Submitted That Met QC Criteria

April 22, 2026

Last Verified

April 1, 2026

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 2024-04-CQJY-TZYT-001
  • 2024ZY023993 (Other Identifier: Ethics Committee of Chongqing Jiangbei Hospital of Traditional Chinese Medicine)

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

IPD Plan Description

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.

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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