Efficacy of XYZ for Withdrawal Syndrome

NCT07543809 | Completed

• 2 other identifiers: 2024-04-CQJY-TZYT-0012024ZY023993
• Study Type: interventional
• Target: 80
• Locations: 1 country
• Sites: 1

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.

Conditions

Substance Withdrawal Syndrome

Keywords

Tiaozhong-Yiqi Decoction; Substance Withdrawal Syndrome; Randomized Controlled Trial; Network Pharmacology; Traditional Chinese Medicine

Outcome Measures

Primary Outcomes (1)

• Improvement of Withdrawal Syndrome Symptoms

  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 Outcomes (3)

• 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

Study Arms (2)

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.

Other: Tiaozhong-Yiqi Decoction

Conventional Care Control Group

ACTIVE COMPARATOR

Participants receive only routine care, including diet guidance, psychological counseling, and sleep management, without Tiaozhong-Yiqi Decoction intervention.

Other: routine care

Interventions

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.

TZYD Intervention Group

routine care OTHER

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

Conventional Care Control Group

Eligibility Criteria

• Age: 18 Years - 60 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Chongqing Jiangbei Hospital of Traditional Chinese Medicine: lead
• Chongqing University of Chinese Medicine: collaborator

Study Sites (1)

Chongqing Jiangbei Hospital of Traditional Chinese Medicine

Chongqing, Chongqing Municipality, 40020, China

Location

MeSH Terms

Conditions

Substance Withdrawal Syndrome

Condition Hierarchy (Ancestors)

Substance-Related Disorders; Chemically-Induced Disorders; Mental Disorders

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Masking Details: Open-label study, no blinding applied to participants, investigators, or outcome assessors, due to the nature of traditional Chinese medicine decoction intervention.
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER GOV
• Responsible Party: SPONSOR

Model Details: 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.

Study Record Dates

• First Submitted: April 15, 2026
• First Posted: April 22, 2026
• Study Start: May 1, 2024
• Primary Completion: August 31, 2024
• Study Completion: August 31, 2024
• Last Updated: April 27, 2026

Record last verified: 2026-04

Data Sharing

• IPD Sharing: Will not share

Locations

CN (1)