GERDNCT07797959
Thread-Embedding Acupuncture as an Adjunct to Proton Pump Inhibitor Therapy for Gastroesophageal Reflux Disease
A study testing Thread-Embedding Acupuncture in people with GERD and Gastroesophageal Reflux Disease, run by University of Science Ho Chi Minh City at 1 site in Vietnam.
Trial summary
This study aims to evaluate the effectiveness of thread-embedding acupuncture combined with omeprazole in patients with gastroesophageal reflux disease (GERD) presenting with the traditional medicine pattern of Liver-Stomach constraint-heat. Read more about this study
- Who is it for?
- Ages 18 to 60 years
- Conditions the study is for
- GERD, Gastroesophageal Reflux Disease
- What is being tested?
- Thread-Embedding Acupuncture
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 50 participants
- Where
- 1 siteVietnam
- Study dates
- 15 Apr 2026to 18 Sep 2026
- 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 60 years
- All sexes
- No healthy volunteers
- Adult
Who may be able to join
- Aged 18 to 60 years.
- Diagnosed with gastroesophageal reflux disease (GERD) with a GerdQ score ≥8 and typical heartburn and/or regurgitation occurring at least 2 days per week, and considered eligible for proton pump inhibitor therapy according to the ACG 2013 guideline.
- Meets the diagnostic criteria for Liver-Stomach Heat Stagnation Syndrome according to the 2017 expert consensus on traditional medicine syndrome differentiation for GERD.
- No previous diagnosis of GERD within the past 8 weeks.
- Voluntarily agrees to participate in the study and provides written informed consent.
Who cannot join
- Presence of alarm symptoms, including dysphagia, odynophagia, palpable lymph nodes or mass, unintentional weight loss, family history of gastrointestinal malignancy, gastrointestinal bleeding, anemia, or persistent nausea/vomiting.
- Structural gastrointestinal disease confirmed by endoscopy, including esophageal malignancy or other significant organic lesions.
- Current use of medications that may influence GERD assessment or treatment, including glucocorticoids, NSAIDs, bisphosphonates, prostaglandins, oral contraceptives, antifungal agents, or sedative medications.
- Use of proton pump inhibitors, H2-receptor antagonists, or prokinetic agents within the previous 14 days.
- History of hypersensitivity to proton pump inhibitors or absorbable catgut/thread material.
- Skin inflammation, infection, or other dermatologic disease at or around the intended thread-embedding sites.
- Current pregnancy or breastfeeding.
- Currently participating in another interventional clinical study.
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Vietnam1 site, 1 recruiting
- Recruiting
Traditional Medicine Hospital of Ho Chi Minh City
Ho Chi Minh City
Hien Thu Thi Le, MD, +84886725372, mingyingtcm@gmail.com
About this study
Official title: Efficacy and Safety of Thread-Embedding Acupuncture as an Adjunct to Proton Pump Inhibitor Therapy in Patients With Gastroesophageal Reflux Disease and Liver-Stomach Stagnation-Heat Syndrome: A Randomized Controlled Trial
This study aims to evaluate the effectiveness of thread-embedding acupuncture combined with omeprazole in patients with gastroesophageal reflux disease (GERD) presenting with the traditional medicine pattern of Liver-Stomach constraint-heat. Participants will receive either thread-embedding acupuncture combined with omeprazole or the comparator treatment according to the study protocol. Clinical outcomes will be assessed to determine the effectiveness and safety of the intervention.
- Conditions
- GERD, Gastroesophageal Reflux Disease
- Being tested
- Thread-Embedding Acupuncture
- Keywords
- Liver-Stomach constraint-heat, Traditional medicine, Acupoint catgut embedding, Thread-embedding acupuncture, Omeprazole
- Medical subject headings
- Gastroesophageal Reflux
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Thread-Embedding AcupunctureProcedure or surgery
Also called Acupoint Catgut Embedding
Participants will receive acupoint catgut embedding in addition to standard treatment with omeprazole. Acupoint catgut embedding will be performed twice during the 4-week treatment period, at 2-week intervals. Sterile chromic catgut 3/0 will be embedded at Zhongwan (CV12), Shangwan (CV13), Xiawan (CV10), Zusanli (ST36), Tianshu (ST25), and Taichong (LR3) according to the standardized procedure. Participants will be monitored for 30 minutes after each procedure for adverse events.
| Study group | Role | What they receive |
|---|---|---|
| Omeprazole | Active comparator | Participants receive omeprazole according to the treatment regimen specified in the study protocol. Receives: Procedure: Thread-Embedding Acupuncture |
| Thread-Embedding Acupuncture Plus Omeprazole | Experimental | Participants receive thread-embedding acupuncture in combination with omeprazole according to the treatment regimen specified in the study protocol. Receives: Procedure: Thread-Embedding Acupuncture |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change in GERD-Q Score
Gastroesophageal reflux disease symptoms will be assessed using the Gastroesophageal Reflux Disease Questionnaire (GerdQ). The total GerdQ score ranges from 0 to 18, with higher scores indicating more severe gastroesophageal reflux disease symptoms. Change in the total GerdQ score from baseline to 4 weeks will be assessed between the two study groups.
Measured: Baseline and 4 weeks
Secondary outcomes (5)
Treatment Response Based on GerdQ
Treatment response will be defined as a reduction of at least 2 points in the total Gastroesophageal Reflux Disease Questionnaire (GerdQ) score from baseline. The total GerdQ score ranges from 0 to 18, with higher scores indicating more severe gastroesophageal reflux disease symptoms. The proportion of participants achieving treatment response will be compared between the two study groups.
Measured: Baseline and weekly through 4 weeks
Complete Symptom Resolution Based on GerdQ
Complete resolution of typical gastroesophageal reflux disease (GERD) symptoms will be assessed using the Gastroesophageal Reflux Disease Questionnaire (GerdQ). The total GerdQ score ranges from 0 to 18, with higher scores indicating more severe GERD symptoms. Complete symptom resolution will be defined as a score of 0 for both the heartburn and regurgitation items of the GerdQ. The proportion of participants achieving complete symptom resolution at 4 weeks will be compared between the two study groups.
Measured: 4 weeks
Change in Traditional Medicine Symptoms of Liver-Stomach Heat Stagnation Syndrome
Traditional medicine symptoms of Liver-Stomach Stagnated Heat syndrome will be assessed using a syndrome symptom score comprising two main symptoms (burning sensation and acid regurgitation) and six secondary symptoms (retrosternal pain, epigastric burning pain, epigastric fullness, belching or food regurgitation, irritability, and rapid hunger). Each main symptom is rated as absent, mild, moderate, or severe and scored 0, 2, 4, or 6 points, respectively. Each secondary symptom is rated as absent, mild, moderate, or severe and scored 0, 1, 2, or 3 points, respectively. The total score ranges from 0 to 30, with higher scores indicating greater syndrome severity. Change in the total syndrome score from baseline through 4 weeks will be compared between the two study groups.
Measured: Baseline and weekly through 4 weeks
Treatment Response Based on Liver-Stomach Stagnated Heat Syndrome Score
Treatment response for Liver-Stomach Stagnated Heat syndrome will be assessed using the percentage reduction in the total syndrome score from baseline. The efficacy index will be calculated as [(baseline score - post-treatment score) / baseline score] × 100. Clinical cure is defined as an efficacy index of at least 95%, markedly effective as 70% to less than 95%, effective as 30% to less than 70%, and ineffective as less than 30%. The proportion of participants classified as clinically cured, markedly effective, effective, or ineffective at 4 weeks will be compared between the two study groups.
Measured: Baseline and 4 weeks
Adverse Events Associated With Thread-Embedding Acupuncture
Adverse events associated with thread-embedding acupuncture will be monitored throughout the 4-week treatment period. Events of interest include local pain, bleeding, bruising, swelling, infection, allergic reactions, and other treatment-related complications. The number and proportion of participants experiencing at least one adverse event will be recorded and compared between the two study groups.
Measured: Throughout the 4-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 posted1 Sep 2026
- Study start15 Apr 2026
- Primary completion15 Sep 2026 (estimated)
- Study completion18 Sep 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for GERDStudies 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
- 50 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University of Science Ho Chi Minh City
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Dr Nguyen Ngo Le Minh Anh MD, PhD, University of Medicine and Pharmacy at Ho Chi Minh City
- Investigators
- Minh-Anh Nguyen Ngo Le, MD,PhD, Principal investigator, University of Medicine and Pharmacy at Ho Chi Minh CityMinh-Anh Nguyen Ngo Le, MD, PhD, Principal investigator, University of Medicine and Pharmacy at Ho Chi Minh City
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07797959
- Sponsor's protocol ID
- TEA-GERD-RCT2026
- Status last verified
- Aug 2026
- First submitted
- 26 Aug 2026
- Last updated
- 1 Sep 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 1 Sep 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Efficacy and Safety of Thread-Embedding Acupuncture as an Adjunct to Proton Pump Inhibitor Therapy in Patients With Gastroesophageal Reflux Disease and Liver-Stomach Stagnation-Heat Syndrome: A Randomized Controlled Trial
- ClinicalTrials.gov ID
- NCT07797959
- Acronym / sponsor ID
- TEA-GERD-RCT2026
- Conditions
- GERD, Gastroesophageal Reflux Disease
- Keywords
- Liver-Stomach constraint-heat, Traditional medicine, Acupoint catgut embedding, Thread-embedding acupuncture, Omeprazole
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 50 participants (estimated)
- Lead sponsor
- University of Science Ho Chi Minh CityUniversity, hospital or other
- Study start
- 15 Apr 2026 (actual)
- Primary completion
- 15 Sep 2026 (estimated)
- Study completion
- 18 Sep 2026 (estimated)
- First posted
- 1 Sep 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 study aims to evaluate the effectiveness of thread-embedding acupuncture combined with omeprazole in patients with gastroesophageal reflux disease (GERD) presenting with the traditional medicine pattern of Liver-Stomach constraint-heat. Participants will receive either thread-embedding acupuncture combined with omeprazole or the comparator treatment according to the study protocol. Clinical outcomes will be assessed to determine the effectiveness and safety of the intervention.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Omeprazole | Active comparator | Procedure: Thread-Embedding AcupunctureParticipants receive omeprazole according to the treatment regimen specified in the study protocol. |
| Thread-Embedding Acupuncture Plus Omeprazole | Experimental | Procedure: Thread-Embedding AcupunctureParticipants receive thread-embedding acupuncture in combination with omeprazole according to the treatment regimen specified in the study protocol. |
Who may qualify
- Ages
- 18 to 60 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (5 listed)
- Aged 18 to 60 years.
- Diagnosed with gastroesophageal reflux disease (GERD) with a GerdQ score ≥8 and typical heartburn and/or regurgitation occurring at least 2 days per week, and considered eligible for proton pump inhibitor therapy according to the ACG 2013 guideline.
- Meets the diagnostic criteria for Liver-Stomach Heat Stagnation Syndrome according to the 2017 expert consensus on traditional medicine syndrome differentiation for GERD.
- No previous diagnosis of GERD within the past 8 weeks.
- Voluntarily agrees to participate in the study and provides written informed consent.
Key exclusion criteria (8 listed)
- Presence of alarm symptoms, including dysphagia, odynophagia, palpable lymph nodes or mass, unintentional weight loss, family history of gastrointestinal malignancy, gastrointestinal bleeding, anemia, or persistent nausea/vomiting.
- Structural gastrointestinal disease confirmed by endoscopy, including esophageal malignancy or other significant organic lesions.
- Current use of medications that may influence GERD assessment or treatment, including glucocorticoids, NSAIDs, bisphosphonates, prostaglandins, oral contraceptives, antifungal agents, or sedative medications.
- Use of proton pump inhibitors, H2-receptor antagonists, or prokinetic agents within the previous 14 days.
- History of hypersensitivity to proton pump inhibitors or absorbable catgut/thread material.
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 |
|---|---|---|
| Thread-Embedding AcupunctureAlso: Acupoint Catgut EmbeddingParticipants will receive acupoint catgut embedding in addition to standard treatment with omeprazole. Acupoint catgut embedding will be performed twice during the 4-week treatment period, at 2-week intervals. Sterile chromic catgut 3/0 will be embedded at Zhongwan (CV12), Shangwan (CV13), Xiawan (CV10), Zusanli (ST36), Tianshu (ST25), and Taichong (LR3) according to the standardized procedure. Participants will be monitored for 30 minutes after each procedure for adverse events. | Procedure or surgery | Omeprazole, Thread-Embedding Acupuncture Plus Omeprazole |
Primary outcome
Change in GERD-Q Score
Time frame: Baseline and 4 weeks
Gastroesophageal reflux disease symptoms will be assessed using the Gastroesophageal Reflux Disease Questionnaire (GerdQ). The total GerdQ score ranges from 0 to 18, with higher scores indicating more severe gastroesophageal reflux disease symptoms. Change in the total GerdQ score from baseline to 4 weeks will be assessed between the two study groups.
5 secondary outcomes
Treatment Response Based on GerdQ
Time frame: Baseline and weekly through 4 weeks
Complete Symptom Resolution Based on GerdQ
Time frame: 4 weeks
Change in Traditional Medicine Symptoms of Liver-Stomach Heat Stagnation Syndrome
Time frame: Baseline and weekly through 4 weeks
Treatment Response Based on Liver-Stomach Stagnated Heat Syndrome Score
Time frame: Baseline and 4 weeks
Adverse Events Associated With Thread-Embedding Acupuncture
Time frame: Throughout the 4-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 1 Sep 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.
Minh-Anh Nguyen Ngo Le, MD,PhD principal investigator
University of Medicine and Pharmacy at Ho Chi Minh City
Minh-Anh Nguyen Ngo Le, MD, PhD principal investigator
University of Medicine and Pharmacy at Ho Chi Minh City
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Thread-Embedding Acupuncture in people with GERD and Gastroesophageal Reflux Disease, run by University of Science Ho Chi Minh City at 1 site in Vietnam.
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 8 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: looking for participants now, as of the sponsor's last update on 1 Sep 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 Vietnam. 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 Minh-Anh Nguyen Ngo Le, MD, PhD (+84 962 644 648, drminhanh@ump.edu.vn), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change in GERD-Q Score (time frame: Baseline and 4 weeks). 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 1 Sep 2026.