Chronic MigraineNCT07633522
Fire Needling Plus Filiform Needling for Chronic Migraine With Comorbid Tension-Type Headache
A study testing filiform needling and fire needling combined with filiform needling in people with Chronic Migraine and Tension-type Headache, run by Beijing Hospital of Traditional Chinese Medicine at 3 sites in China.
Trial summary
The investigators conducted a multicenter, prospective, randomized controlled clinical study to learn whether fire needling combined with filiform needling applied to pericranial muscle tenderness areas can effectively treat chronic migraine with comorbid tension-type headache. Read more about this study
- Who is it for?
- Ages 18 to 65 years
- Conditions the study is for
- Chronic Migraine, Tension-type Headache
- What is being tested?
- filiform needling and fire needling combined with filiform needling
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 88 participants
- Where
- 3 sitesChina
- Study dates
- Aug 2026to Dec 2028
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
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 65 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Meets the diagnostic criteria for tension-type headaches with pericranial tenderness;
- Meets the diagnostic criteria for chronic migraine;
- 18 years ≤ age ≤ 65 years;
- Has sufficient understanding to complete the necessary examinations and tests for the study;
- Voluntarily joins this study and signs the informed consent form.
Who cannot join
- Patients complicated with cluster headache or other primary headaches;
- Patients with secondary headaches caused by intracranial space-occupying lesions, cranial infections, etc.;
- Patients complicated with severe heart, liver or kidney impairment, coagulation disorders, infections, severe immunocompromise, or allergic predisposition;
- Patients with alcohol or drug dependence;
- Patients who are unable to cooperate with acupuncture treatment;
- Women who are planning pregnancy, pregnant or breastfeeding;
- Patients who have received acupuncture treatment within 3 months prior to enrollment.
Trial locations and contacts
3 sites in 1 country. Contact the study team or a site near you to ask about taking part.
China3 sites
Beijing Hospital of Traditional Chinese Medicine
Beijing, Beijing Municipality, 100010
Dong Jingwen Dong, +8613241104543, a13241104543@163.com
Hui Lin Liu, 13681395789, liuhuilin@bjzhongyi.com
Beijing Tiantan Hospital, Capital Medical University
Beijing, Beijing Municipality, 100070
baokai Wang, 86+010+59976611, wbk04@126.com
baokai Wang
Capital Medical University Affiliated Beijing Tongren Hospital
Beijing, Beijing Municipality, 100730
luquan Chen, 86+13611373920, chenluquan@ccmu.edu
luquan Chen
About this study
Official title: Clinical Research on Fire Needling Combined With Filiform Needling for Chronic Migraine With Comorbid Tension-type Headache
The investigators conducted a multicenter, prospective, randomized controlled clinical study to learn whether fire needling combined with filiform needling applied to pericranial muscle tenderness areas can effectively treat chronic migraine with comorbid tension-type headache. The study will also evaluate the safety and long-term efficacy of this therapy. Its main target questions include:
- Can fire needling significantly reduce the number of headache days per month?
- What is the effect of this therapy on headache intensity, emotional symptoms, and quality of life? The investigators will compare "fire needling at pericranial tender points plus conventional filiform needling" versus "conventional filiform needling alone" to verify whether the key technique of fire needling plus conventional filiform needling provides unique additive value.
Read more
Participants will:
- Receive treatment twice per week for 8 weeks (either in the experimental group or the control group)，attend a follow-up visit at week 24 after enrollment
- Keep a headache diary (recording headache frequency, pain intensity, duration, associated symptoms, etc.)
- Regularly complete assessments of emotional status, quality of life, and number of pericranial tender points
Read the detailed description
Based on international research progress and our preliminary findings, our team proposes that headache episodes in chronic migraine often present with clinical features of tension-type headache. Patients commonly exhibit widespread pericranial muscle tenderness. Integrating the trigemino-cervical complex (TCC) pathway theory and the long-term foundation of acupuncture treatment for tension-type headache, the investigators propose that chronic migraine primarily develops from the comorbidity of migraine and tension-type headache, with pericranial muscle tenderness being a key pathogenic factor and therapeutic target. Fire-needle pinpointing of tender points in pericranial muscles is a key technique for achieving favorable outcomes.
This multicenter randomized controlled trial will enroll 88 patients with chronic migraine comorbid with tension-type headache. They will be randomly allocated in a 1:1 ratio to either the experimental group or the control group via a central randomization system. The experimental group will receive "fire-needle pinpointing of pericranial tender points plus conventional filiform needle acupuncture," while the control group will receive "conventional filiform needle acupuncture" only. Treatment will be administered twice weekly for 8 weeks, with a follow-up period of 24 weeks.
The study will evaluate clinical efficacy and safety by comparing the two groups in terms of headache days, pain intensity, duration, associated symptoms, emotional status, quality of life, number of pericranial tender points, and safety indicators before and after treatment and at the end of the follow-up period. The aim is to confirm that "pericranial muscle tender areas are the key therapeutic target for chronic migraine comorbid with tension-type headache" and that "fire-needle pinpointing is the key technique for this target." The primary outcome will be the internationally recognized headache frequency. Secondary outcomes will include headache intensity, headache-related emotional symptoms, and health-related quality of life. Long-term follow-up will assess sustained effects, with the goal of providing an acupuncture-based treatment strategy to significantly improve the clinical efficacy for chronic migraine.
- Conditions
- Chronic Migraine, Tension-type Headache
- Being tested
- filiform needling, fire needling combined with filiform needling
- Keywords
- fire needling, filiform needling, chronic migranie, tension-type headache
- Medical subject headings
- Tension-Type Headache
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
filiform needlingProcedure or surgery
Selection of acupoints for filiform needle therapy is integrated with the international standard acupuncture preventive treatment protocol for migraine specified in Acupuncture Clinical Practice Guidelines for Migraine issued by the World Federation of Acupuncture-Moxibustion Societies （WFAS 007.8-2023）.Treatment was administered twice weekly for 8 weeks.
Main Acupoints:
Baihui (GV20), Shenting (GV24), Fengchi (GB20, bilateral), Benshen (GB13, bilateral), Shuaigu (GB8, bilateral), Taiyang (EX-HN5, bilateral).
Adjunct Acupoints:
For shaoyang headache: add Toulinqi (GB15), Yangbai (GB14), Fubai (GB10), Zulinqi (GB41), Waiguan (SJ5), Yanglingquan (GB34); For yangming headache: add Touwei (ST8), Hegu (LI4), Neiting (ST44); For taiyang headache: add Kunlun (BL60), Houxi (SI3); For jueyin headache: add Taichong (LR3), Qiuxu (GB40).
fire needling combined with filiform needlingProcedure or surgery
Fire needling was used to puncture pericranial muscle tenderness areas (including the external occipital protuberance, superior nuchal line, nuchal plane, mastoid process; cervicoscapular areas; epicranial aponeurosis - frontal and temporal regions; upper trapezius, sternocleidomastoid, levator scapulae, temporalis, masseter, and occipitofrontalis muscles) in addition to filiform needling at meridian acupoints (same acupoints as the filiform needling group). Treatment was administered twice weekly for 8 weeks.
| Study group | Role | What they receive |
|---|---|---|
| filiform needling | Active comparator | This point selection protocol follows the international standard acupuncture preventive treatment regimen specified in the Acupuncture Clinical Practice Guideline: Migraine (WFAS 007.8-2023) issued by the World Federation of Acupuncture-Moxibustion Societies (WFAS).
Main Points Baihui (GV20), Shenting (GV24), Fengchi (GB20, bilateral), Benshen (GB13, bilateral), Shuaigu (GB8, bilateral), Taiyang (EX-HN5, bilateral).
Adjuvant Points For Shaoyang headache: add Toulinqi (GB15), Yangbai (GB14), Fubai (GB10), Zulinqi (GB41), Waiguan (TE5), Yanglingquan (GB34).
For Yangming headache: add Touwei (ST8), Hegu (LI4), Neiting (ST44). For Taiyang headache: add Kunlun (BL60), Houxi (SI3). For Jueyin headache: add Taichong (LR3), Qiuxu (GB40). Procedure Fengchi (GB20) is needled 0.5-1 cun toward the nasal tip. All other points are needled perpendicularly. Following the arrival of de qi, even reinforcing-reducing method is applied, with needles retained for 30 minutes. Receives: Procedure: filiform needling |
| fire needling combined with filiform needling | Experimental | Fire needle prickling was applied to the pericranial tenderness areas, combined with filiform needle acupuncture at meridian points. The acupoint prescription for filiform needle acupuncture was identical to that in the control group. Receives: Procedure: fire needling combined with filiform needling |
What is being measured
The primary outcome is the main question the study is designed to answer.
Treatment efficacy
Based on the statistics from the headache diaries completed by patients, it is defined as the proportion of subjects who achieve a reduction in headache days of ≥50% after treatment compared to before treatment.
Measured: At week 8 of treatment, and follow-up at week 24 of enrollment
Secondary outcomes (11)
Headache days
Measured: Baseline, at week 8 of treatment, and follow-up at week 24 of enrollment.
Headache Duration
Measured: Baseline, at week 8 of treatment, and 24 weeks after enrollment follow-up.
Headache severity
Measured: Baseline, at week 8 of treatment, and 24 weeks after enrollment follow-up.
The proportion of monthly headache attacks occurring ≤1 time per month
Measured: Baseline, at week 8 of treatment, and 24 weeks after enrollment follow-up.
Migraine-Specific Quality of Life Questionnaire(MSQ) (Version 2.1)
This is a 14-item questionnaire that measures how migraines affect a patient's daily life and is a highly reliable and valid instrument. The raw scores are transformed to a 0-100 scale and higher scores reflect greater quality of life.
Measured: Baseline, at week 8 of treatment, and 24 weeks after enrollment follow-up.
Hamilton Depression Rating Scale, 24-item (HAMD-24)
The HAMD-24 is a clinician-administered scale used to assess the severity of depressive symptoms. It consists of 24 items, most of which are scored from 0 to 4 (0 = absent, 4 = very severe), and a few items are scored from 0 to 2 (0 = absent, 2 = marked). The total score ranges from 0 to 76, with higher scores indicating more severe depression.
Measured: Baseline, at week 8 of treatment, and 24 weeks after enrollment follow-up.
Hamilton Anxiety Rating Scale, 14-item
The HAMA-14 is a clinician-administered scale used to assess the severity of anxiety symptoms. It consists of 14 items, each scored on a 5-point scale from 0 (not present) to 4 (very severe). The total score ranges from 0 to 56, with higher scores indicating more severe anxiety.
Measured: Baseline, at week 8 of treatment, and 24 weeks after enrollment follow-up.
The number of tender areas in pericranial muscles and their distribution
By palpation
Measured: Baseline, at week 8 of treatment
Pericranial muscle tender area tenderness threshold
The subject is instructed to relax naturally and sit on a chair with a backrest. The researcher uses an electronic pressure meter (SHSCYQ ZMF-50) to perform standardized assessment and recording of the tender points identified through palpation. A 1 cm² circular probe of the device is placed perpendicularly over the palpated tender point and pressed evenly into the skin at a rate of 0.5 N/s. The subject presses a feedback button as soon as pain is felt, and the pressure value displayed at that moment is recorded. Each tender point is measured three times, with an interval of 10 to 15 seconds between measurements. The average of the three values is calculated as the pressure pain threshold for that tender point.
Measured: Baseline, at week 8 of treatment
The status of painkiller intake among subjects
Measured: Baseline, at week 8 of treatment, and 24 weeks after enrollment follow-up.
Recording of adverse events
Document adverse events such as needle syncope, hematoma, etc. during acupuncture, along with their grading and management measures.
Measured: During the 8-week treatment period
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted8 Jun 2026
- Study startAug 2026 (estimated)
- Primary completionDec 2028 (estimated)
- Study completionDec 2028 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Chronic MigraineStudies 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
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 88 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Beijing Hospital of Traditional Chinese Medicine
- Sponsor type
- University, hospital or other
- Collaborators
- Capital's Funds for Health Improvement and Research
- Responsible party
- Principal investigator, Huilin Liu, Beijing Hospital of Traditional Chinese Medicine
- Investigators
- Liu Hui Lin Liu, Principal investigator, Beijing Hospital of Traditional Chinese Medicine
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07633522
- Sponsor's protocol ID
- 2026BL02-023-01
- Other IDs
- 2026-2-2233
- Status last verified
- Jun 2026
- First submitted
- 18 May 2026
- Last updated
- 8 Jun 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 8 Jun 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Clinical Research on Fire Needling Combined With Filiform Needling for Chronic Migraine With Comorbid Tension-type Headache
- ClinicalTrials.gov ID
- NCT07633522
- Acronym / sponsor ID
- 2026BL02-023-01
- Conditions
- Chronic Migraine, Tension-type Headache
- Keywords
- fire needling, filiform needling, chronic migranie, tension-type headache
- Study type
- Interventional
- Recruitment status
- Not yet recruiting
- Enrolment
- 88 participants (estimated)
- Lead sponsor
- Beijing Hospital of Traditional Chinese MedicineUniversity, hospital or other
- Collaborators
- Capital's Funds for Health Improvement and Research
- Study start
- Aug 2026 (estimated)
- Primary completion
- Dec 2028 (estimated)
- Study completion
- Dec 2028 (estimated)
- First posted
- 8 Jun 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.
The investigators conducted a multicenter, prospective, randomized controlled clinical study to learn whether fire needling combined with filiform needling applied to pericranial muscle tenderness areas can effectively treat chronic migraine with comorbid tension-type headache. The study will also evaluate the safety and long-term efficacy of this therapy. Its main target questions include:
- Can fire needling significantly reduce the number of headache days per month?
- What is the effect of this therapy on headache intensity, emotional symptoms, and quality of life? The investigators will compare "fire needling at pericranial tender points plus conventional filiform needling" versus "conventional filiform needling alone" to verify whether the key technique of fire needling plus conventional filiform needling provides unique additive value.
Participants will:
- Receive treatment twice per week for 8 weeks (either in the experimental group or the control group)，attend a follow-up visit at week 24 after enrollment
- Keep a headache diary (recording headache frequency, pain intensity, duration, associated symptoms, etc.)
- Regularly complete assessments of emotional status, quality of life, and number of pericranial tender points
Detailed description
Based on international research progress and our preliminary findings, our team proposes that headache episodes in chronic migraine often present with clinical features of tension-type headache. Patients commonly exhibit widespread pericranial muscle tenderness. Integrating the trigemino-cervical complex (TCC) pathway theory and the long-term foundation of acupuncture treatment for tension-type headache, the investigators propose that chronic migraine primarily develops from the comorbidity of migraine and tension-type headache, with pericranial muscle tenderness being a key pathogenic factor and therapeutic target. Fire-needle pinpointing of tender points in pericranial muscles is a key technique for achieving favorable outcomes.
This multicenter randomized controlled trial will enroll 88 patients with chronic migraine comorbid with tension-type headache. They will be randomly allocated in a 1:1 ratio to either the experimental group or the control group via a central randomization system. The experimental group will receive "fire-needle pinpointing of pericranial tender points plus conventional filiform needle acupuncture," while the control group will receive "conventional filiform needle acupuncture" only. Treatment will be administered twice weekly for 8 weeks, with a follow-up period of 24 weeks.
The study will evaluate clinical efficacy and safety by comparing the two groups in terms of headache days, pain intensity, duration, associated symptoms, emotional status, quality of life, number of pericranial tender points, and safety indicators before and after treatment and at the end of the follow-up period. The aim is to confirm that "pericranial muscle tender areas are the key therapeutic target for chronic migraine comorbid with tension-type headache" and that "fire-needle pinpointing is the key technique for this target." The primary outcome will be the internationally recognized headache frequency. Secondary outcomes will include headache intensity, headache-related emotional symptoms, and health-related quality of life. Long-term follow-up will assess sustained effects, with the goal of providing an acupuncture-based treatment strategy to significantly improve the clinical efficacy for chronic migraine.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| filiform needling | Active comparator | Procedure: filiform needlingThis point selection protocol follows the international standard acupuncture preventive treatment regimen specified in the Acupuncture Clinical Practice Guideline: Migraine (WFAS 007.8-2023) issued by the World Federation of Acupuncture-Moxibustion Societies (WFAS). Main Points Baihui (GV20), Shenting (GV24), Fengchi (GB20, bilateral), Benshen (GB13, bilateral), Shuaigu (GB8, bilateral), Taiyang (EX-HN5, bilateral). Adjuvant Points For Shaoyang headache: add Toulinqi (GB15), Yangbai (GB14), Fubai (GB10), Zulinqi (GB41), Waiguan (TE5), Yanglingquan (GB34). For Yangming headache: add Touwei (ST8), Hegu (LI4), Neiting (ST44). For Taiyang headache: add Kunlun (BL60), Houxi (SI3). For Jueyin headache: add Taichong (LR3), Qiuxu (GB40). Procedure Fengchi (GB20) is needled 0.5-1 cun toward the nasal tip. All other points are needled perpendicularly. Following the arrival of de qi, even reinforcing-reducing method is applied, with needles retained for 30 minutes. |
| fire needling combined with filiform needling | Experimental | Procedure: fire needling combined with filiform needlingFire needle prickling was applied to the pericranial tenderness areas, combined with filiform needle acupuncture at meridian points. The acupoint prescription for filiform needle acupuncture was identical to that in the control group. |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- Meets the diagnostic criteria for tension-type headaches with pericranial tenderness;
- Meets the diagnostic criteria for chronic migraine;
- 18 years ≤ age ≤ 65 years;
- Has sufficient understanding to complete the necessary examinations and tests for the study;
- Voluntarily joins this study and signs the informed consent form.
Key exclusion criteria (7 listed)
- Patients complicated with cluster headache or other primary headaches;
- Patients with secondary headaches caused by intracranial space-occupying lesions, cranial infections, etc.;
- Patients complicated with severe heart, liver or kidney impairment, coagulation disorders, infections, severe immunocompromise, or allergic predisposition;
- Patients with alcohol or drug dependence;
- Patients who are unable to cooperate with acupuncture treatment;
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 |
|---|---|---|
| filiform needlingSelection of acupoints for filiform needle therapy is integrated with the international standard acupuncture preventive treatment protocol for migraine specified in Acupuncture Clinical Practice Guidelines for Migraine issued by the World Federation of Acupuncture-Moxibustion Societies （WFAS 007.8-2023）.Treatment was administered twice weekly for 8 weeks. Main Acupoints: Baihui (GV20), Shenting (GV24), Fengchi (GB20, bilateral), Benshen (GB13, bilateral), Shuaigu (GB8, bilateral), Taiyang (EX-HN5, bilateral). Adjunct Acupoints: For shaoyang headache: add Toulinqi (GB15), Yangbai (GB14), Fubai (GB10), Zulinqi (GB41), Waiguan (SJ5), Yanglingquan (GB34); For yangming headache: add Touwei (ST8), Hegu (LI4), Neiting (ST44); For taiyang headache: add Kunlun (BL60), Houxi (SI3); For jueyin headache: add Taichong (LR3), Qiuxu (GB40). | Procedure or surgery | filiform needling |
| fire needling combined with filiform needlingFire needling was used to puncture pericranial muscle tenderness areas (including the external occipital protuberance, superior nuchal line, nuchal plane, mastoid process; cervicoscapular areas; epicranial aponeurosis - frontal and temporal regions; upper trapezius, sternocleidomastoid, levator scapulae, temporalis, masseter, and occipitofrontalis muscles) in addition to filiform needling at meridian acupoints (same acupoints as the filiform needling group). Treatment was administered twice weekly for 8 weeks. | Procedure or surgery | fire needling combined with filiform needling |
Primary outcome
Treatment efficacy
Time frame: At week 8 of treatment, and follow-up at week 24 of enrollment
Based on the statistics from the headache diaries completed by patients, it is defined as the proportion of subjects who achieve a reduction in headache days of ≥50% after treatment compared to before treatment.
11 secondary outcomes
Headache days
Time frame: Baseline, at week 8 of treatment, and follow-up at week 24 of enrollment.
Headache Duration
Time frame: Baseline, at week 8 of treatment, and 24 weeks after enrollment follow-up.
Headache severity
Time frame: Baseline, at week 8 of treatment, and 24 weeks after enrollment follow-up.
The proportion of monthly headache attacks occurring ≤1 time per month
Time frame: Baseline, at week 8 of treatment, and 24 weeks after enrollment follow-up.
Migraine-Specific Quality of Life Questionnaire(MSQ) (Version 2.1)
Time frame: Baseline, at week 8 of treatment, and 24 weeks after enrollment follow-up.
Hamilton Depression Rating Scale, 24-item (HAMD-24)
Time frame: Baseline, at week 8 of treatment, and 24 weeks after enrollment follow-up.
Hamilton Anxiety Rating Scale, 14-item
Time frame: Baseline, at week 8 of treatment, and 24 weeks after enrollment follow-up.
The number of tender areas in pericranial muscles and their distribution
Time frame: Baseline, at week 8 of treatment
Pericranial muscle tender area tenderness threshold
Time frame: Baseline, at week 8 of treatment
The status of painkiller intake among subjects
Time frame: Baseline, at week 8 of treatment, and 24 weeks after enrollment follow-up.
Recording of adverse events
Time frame: During the 8-week treatment period
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 8 Jun 2026.
- Individual participant dataSharing planned: No
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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.
Liu Hui Lin Liu principal investigator
Beijing Hospital of Traditional Chinese Medicine
3 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing filiform needling and fire needling combined with filiform needling in people with Chronic Migraine and Tension-type Headache, run by Beijing Hospital of Traditional Chinese Medicine at 3 sites 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 7 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: opening soon, as of the sponsor's last update on 8 Jun 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 3 sites 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?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Jingwen Dong (+8613241104543, a13241104543@163.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Treatment efficacy (time frame: At week 8 of treatment, and follow-up at week 24 of enrollment). 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 8 Jun 2026.