Substance Withdrawal SyndromeTZYT-WSNCT07543809
Efficacy of XYZ for Withdrawal Syndrome
A study testing Tiaozhong-Yiqi Decoction and routine care in people with Substance Withdrawal Syndrome, run by Chongqing Jiangbei Hospital of Traditional Chinese Medicine at 1 site in China.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 60 years
- Conditions the study is for
- Substance Withdrawal Syndrome
- What is being tested?
- Tiaozhong-Yiqi Decoction and routine care
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 80 participants
- Where
- 1 siteChina
- Study dates
- 1 May 2024to 31 Aug 2024
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 60 years
- All sexes
- No healthy volunteers
- Adult
Who may be able to join
- 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
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country.
China1 site
Chongqing Jiangbei Hospital of Traditional Chinese Medicine
Chongqing, Chongqing Municipality, 40020
About this study
Official title: 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).
Read more
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.
Read the 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).
- Conditions
- Substance Withdrawal Syndrome
- Being tested
- Tiaozhong-Yiqi Decoction, routine care
- Keywords
- Tiaozhong-Yiqi Decoction, Substance Withdrawal Syndrome, Randomized Controlled Trial, Network Pharmacology, Traditional Chinese Medicine
- Medical subject headings
- Substance Withdrawal Syndrome
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Tiaozhong-Yiqi DecoctionOther
Traditional Chinese medicine decoction. 200 mL per dose, orally twice daily for 3 consecutive months, for the treatment of substance withdrawal syndrome.
routine careOther
Routine clinical care including diet guidance, psychological counseling, and sleep hygiene management, without traditional Chinese medicine intervention.
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: 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. Receives: Other: routine care |
What is being measured
The primary outcome is the main question the study is designed to answer.
Improvement of Withdrawal Syndrome Symptoms
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).
Measured: Change from baseline at 3 months
Secondary outcomes (3)
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.
Measured: Change from baseline at 3 months
Serum Inflammatory Factor Levels
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.
Measured: 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).
Measured: Change from baseline at 3 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted22 Apr 2026
- Study start1 May 2024
- Primary completion31 Aug 2024
- Study completion31 Aug 2024
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Substance Withdrawal SyndromeStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- 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.
- Masking
- None (open label)
- Enrolment
- 80 participants (actual)
Sponsor and investigators
- Lead sponsor
- Chongqing Jiangbei Hospital of Traditional Chinese Medicine
- Sponsor type
- Other government
- Collaborators
- Chongqing University of Chinese Medicine
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07543809
- Sponsor's protocol ID
- 2024-04-CQJY-TZYT-001
- Other IDs
- 2024ZY023993
- Acronym
- TZYT-WS
- Status last verified
- Apr 2026
- First submitted
- 15 Apr 2026
- Last updated
- 27 Apr 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: 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.
Study at a glance
From the registry record, last updated by the sponsor on 27 Apr 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Efficacy and Mechanism of Tiaozhong-Yiqi-Tang in the Treatment of Substance Withdrawal Syndrome Based on Network Pharmacology Analysis and Prospective Clinical Validation
- ClinicalTrials.gov ID
- NCT07543809
- Acronym / sponsor ID
- TZYT-WS / 2024-04-CQJY-TZYT-001
- Conditions
- Substance Withdrawal Syndrome
- Keywords
- Tiaozhong-Yiqi Decoction, Substance Withdrawal Syndrome, Randomized Controlled Trial, Network Pharmacology, Traditional Chinese Medicine
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 80 participants (actual)
- Lead sponsor
- Chongqing Jiangbei Hospital of Traditional Chinese MedicineOther government
- Collaborators
- Chongqing University of Chinese Medicine
- Study start
- 1 May 2024 (actual)
- Primary completion
- 31 Aug 2024 (actual)
- Study completion
- 31 Aug 2024 (actual)
- First posted
- 22 Apr 2026 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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).
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
- 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.
| Arm | Type | Receives |
|---|---|---|
| TZYD Intervention Group | Experimental | Other: Tiaozhong-Yiqi DecoctionParticipants receive Tiaozhong-Yiqi Decoction 200mL orally twice daily for 3 consecutive months, combined with routine care for substance withdrawal syndrome. |
| Conventional Care Control Group | Active comparator | Other: routine careParticipants receive only routine care, including diet guidance, psychological counseling, and sleep management, without Tiaozhong-Yiqi Decoction intervention. |
Who may qualify
- Ages
- 18 to 60 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (5 listed)
- 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
Key exclusion criteria (5 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Tiaozhong-Yiqi DecoctionTraditional Chinese medicine decoction. 200 mL per dose, orally twice daily for 3 consecutive months, for the treatment of substance withdrawal syndrome. | Other | TZYD Intervention Group |
| routine careRoutine clinical care including diet guidance, psychological counseling, and sleep hygiene management, without traditional Chinese medicine intervention. | Other | Conventional Care Control Group |
Primary outcome
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).
3 secondary outcomes
Serum Neurotransmitter Levels
Time frame: Change from baseline at 3 months
Serum Inflammatory Factor Levels
Time frame: Change from baseline at 3 months
Quality of Life Score
Time frame: Change from baseline at 3 months
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 27 Apr 2026.
- Individual participant dataSharing planned: No. 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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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Tiaozhong-Yiqi Decoction and routine care in people with Substance Withdrawal Syndrome, run by Chongqing Jiangbei Hospital of Traditional Chinese Medicine at 1 site in China.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 5 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 27 Apr 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in China. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Improvement of Withdrawal Syndrome Symptoms (time frame: Change from baseline at 3 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 27 Apr 2026.