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Chronic Atrophic GastritisNCT07152860

Evaluation of the Efficacy of Electroacupuncture in the Treatment of Chronic Atrophic Gastritis

A study testing 5 Hz electroacupuncture combined tipronone capsules and Simple tipronone capsules group(The basic treatment group) in people with Chronic Atrophic Gastritis, run by Yi Liang at 3 sites in China.

Not yet recruiting

Opening soon. The study is approved but enrolment has not started yet. Sites may already take enquiries.

Sites and contacts
Official record
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Trial summary

Brief Summary Template for the Study: This clinical trial aims to evaluate whether electroacupuncture can treat chronic atrophic gastritis (CAG) in adult subjects aged 18 to 75 years (including both males and females), all of whom have been diagnosed with CAG based on endoscopic and histopathological criteria. Read more about this study

Who is it for?
Ages 18 to 75 years
Conditions the study is for
Chronic Atrophic Gastritis
What is being tested?
5 Hz electroacupuncture combined tipronone capsules and Simple tipronone capsules group(The basic treatment group)
Type of treatment
Pill or oral medicine
Could I receive a placebo?
No, everyone receives an active treatment
How many people
100 participants
Where
3 sitesChina
Study dates
30 Dec 2025to 30 Dec 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 75 years
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • Meets the diagnostic criteria for chronic atrophic gastritis (CAG) (at the time of enrolment, participants must provide reports from endoscopic and pathological examinations conducted within the past year prior to the study start date, both of which indicate chronic atrophic gastritis)
  • Age between 18 and 75 years old, no gender restrictions;
  • Has not received acupuncture treatment within the past month;
  • Not participated in any other ongoing studies within the past 2 months.
  • Understand and agree to participate in this study and sign the informed consent form.

Who cannot join

  • Autoimmune gastritis (type A chronic atrophic gastritis);
  • Participants with a positive C-13 urea breath test at baseline (Helicobacter pylori infection);
  • Patients diagnosed with high-grade intraepithelial neoplasia based on upper gastrointestinal endoscopy and gastric mucosal biopsy pathology;
  • Patients with confirmed or unresolved malignant tumours, particularly oesophageal cancer and gastric cancer; patients with other upper gastrointestinal lesions such as peptic ulcers or Barrett's oesophagus;
  • Patients with severe lesions in major organs (heart, liver, kidney, lung, etc.) or other autoimmune diseases (rheumatic diseases, Crohn's disease, autoimmune pancreatitis, etc.); Persons with cardiac pacemakers;
  • Pregnant and lactating women;
Show all 10Show fewer
  • Patients with infectious diseases such as tuberculosis, hepatitis, or HIV/AIDS;
  • Individuals with a history of alcohol abuse, drug use, or illicit drug use;
  • Individuals who have used other prokinetic agents, mucosal protectants, acid-suppressing medications, or related traditional Chinese medicines within the past two weeks;
  • Individuals currently participating in or who have participated in other clinical trials within the past two months; individuals unable to tolerate acupuncture or with contraindications for acupuncture treatment; and individuals deemed unsuitable for participation in this clinical trial by the research team.

Trial locations and contacts

3 sites in 1 country. Contact the study team or a site near you to ask about taking part.

Yi Liang, Doctor contact

+86 571 86633328

liangyiwww@126.com

China3 sites
  • Hangzhou TCM Hospital of Zhejiang Chinese Medical University (Hangzhou Hospital of Traditional Chinese Medicine)

    Hangzhou, Zhejiang, 310007

    Han Zhang, Doctor, +86 571 86633328, 492660946@qq.com

    Han Zhang, +86-18969048560, 492660946@qq.com

  • Hangzhou First People's Hospital

    Hangzhou, Zhejiang, 310053

    Han Zhang, +86 571 86633328, 492660946@qq.com

    Yang Yu, +86-18969048560, 15629992639@163.com

  • The Third Affiliated Hospital of Zhejiang Chinese Medicinal University

    Hangzhou, Zhejiang, 310053

    Yang Yu, Doctor, +86 571 86633328, 15629992639@163.com

    Yang Yu, 15629992639@163.com

Other trials in China

About this study

Official title: Evaluation of the Efficacy of Electroacupuncture in the Treatment of Chronic Atrophic Gastritis: A Randomized Controlled Trial

Brief Summary Template for the Study:

This clinical trial aims to evaluate whether electroacupuncture can treat chronic atrophic gastritis (CAG) in adult subjects aged 18 to 75 years (including both males and females), all of whom have been diagnosed with CAG based on endoscopic and histopathological criteria. The primary objectives of this study are to answer the following questions:

Read more
  • Can 5 Hz electroacupuncture therapy reverse the pathological state of the gastric mucosa in patients with chronic atrophic gastritis?
  • Can 5 Hz electroacupuncture therapy improve gastrointestinal symptoms in patients with chronic atrophic gastritis?
  • Is there a difference in efficacy between the combination of 5 Hz electroacupuncture therapy and gastric mucosa protectants versus the use of gastric mucosa protectants alone in the treatment of chronic atrophic gastritis?

Researchers will compare the effects of 5 Hz electroacupuncture combined with gastric mucosal protectants versus gastric mucosal protectants alone to determine which method can reverse the pathological state of gastric mucosa and provide more significant symptom relief.

Participants will:

  • Receive acupuncture treatment at specific acupoints (such as Shangwan(CV13), Zhongwan (CV12) ,Xiawan(CV10), Liangmen (ST21), Tianshu (ST25), Zusanli (ST36), and Xiajuxu (ST39).) Electroacupuncture is administered at the abdominal points 'CV13-CV12' and 'ST21-ST21', alongside bilateral lower limb points 'ST36-ST39', using an SDZ-IIB handheld electroacupuncture device (Huatuo brand, Suzhou Medical Supplies Factory Co., Ltd.). Receive electroacupuncture treatment at 5Hz.for 30-minute sessions, three times weekly for 1-8 weeks; twice weekly from weeks 9 to 16, once weekly from weeks 17 to 24, for a total of 24 weeks, comprising 48 treatment sessions.
  • Be randomly assigned to one of the following groups: 5 Hz electroacupuncture combined with gastric mucosal protective agent group or gastric mucosal protective agent group (control group).
  • Have their dyspepsia symptoms, quality of life, and any adverse reactions continuously monitored and assessed throughout the study period.
Being tested
5 Hz electroacupuncture combined tipronone capsules, Simple tipronone capsules group(The basic treatment group)
Keywords
Chronic atrophic gastritis, electroacupuncture
Medical subject headings
Gastritis, Atrophic

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • 5 Hz electroacupuncture combined tipronone capsulesOther

    Intervention Description: The intervention in this study involves the use of electroacupuncture (EA), a combination of traditional acupuncture and electrical stimulation. Acupoints Selection: Electroacupuncture will be performed at specific acupoints associated with the stomach and digestive system. Shangwan(CV13), Zhongwan (CV12) ,Xiawan(CV10), Liangmen (ST21), Tianshu (ST25), Zusanli (ST36), and Xiajuxu (ST39). Disposable needles will be inserted until the "deqi" sensation is achieved. Electroacupuncture is administered at the abdominal points 'CV13-CV12' and 'ST21-ST21', alongside bilateral lower limb points 'ST36-ST39', This selection is based on Traditional Chinese Medicine (TCM) principles for treating chronic atrophic gastritis.

    Frequency: 5 Hz Patients will also be administered SviShu (tipronone capsules) (Wei Cai Pharmaceutical Co., Ltd., National Drug Approval Number H20093656, dosage: 50 mg) orally, one capsule at a time, three times daily, after meals.

  • Simple tipronone capsules group(The basic treatment group)Drug

    Patients in the Simple tipronone capsules group(basic treatment group) will receive only conventional basic drug therapy. They will be given Svi-Shu (tipronone capsules) (Eisai Pharmaceutical Co., Ltd., national drug approval number H20093656, specification: 50 mg) orally, one capsule at a time, three times a day, after meals.

Study groups in NCT07152860
Study groupRoleWhat they receive
Electroacupuncture combined with tipronone capsules groupExperimentalParticipants will receive acupuncture at seven acupoints: Shangwan(CV13), Zhongwan (CV12) ,Xiawan(CV10), Liangmen (ST21), Tianshu (ST25), Zusanli (ST36), and Xiajuxu (ST39). Disposable needles will be inserted until the "deqi" sensation is achieved. Electroacupuncture is administered at the abdominal points 'CV13-CV12' and 'ST21-ST21', alongside bilateral lower limb points 'ST36-ST39', using an SDZ-IIB handheld electroacupuncture device (Huatuo brand, Suzhou Medical Supplies Factory Co., Ltd.). Receive electroacupuncture treatment at 5Hz.Patients will receive acupuncture treatment three times a week for 1-8 weeks, twice a week for 9-16 weeks, and once a week for 17-24 weeks, for a total of 48 treatments. Patients will also be administered SviShu (tipronone capsules) (Wei Cai Pharmaceutical Co., Ltd., National Drug Approval Number H20093656, dosage: 50 mg) orally, one capsule at a time, three times daily, after meals. Treatment will be continued for 24 weeks.
Receives: Other: 5 Hz electroacupuncture combined tipronone capsules
Simple tipronone capsules group(The basic treatment group)Active comparatorPatients in the simple tipronone capsules group(basic treatment group) will receive only conventional basic drug therapy. They will be given Svi-Shu (tipronone capsules) (Eisai Pharmaceutical Co., Ltd., national drug approval number H20093656, specification: 50 mg) orally, one capsule at a time, three times a day, after meals. Treatment will be continued for 24 weeks.
Receives: Drug: Simple tipronone capsules group(The basic treatment group)

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Total pathological response rate after 24 weeks of intervention

    Overall reversal rate (%) = (Total number of cases with OLGA or OLGIM reversal after treatment / Total number of cases) × 100% A reversal case is defined as a case where the patient's OLGA or OLGIM stage at week 24 is lower than the baseline stage (a decrease of ≥1 stage in OLGA or OLGIM stage before and after treatment is defined as a reversal, whereas an increase of ≥1 stage is defined as progression). Any stage reversal is counted toward the total number of reversal cases.

    Measured: 24 weeks after the start of treatment.

Secondary outcomes (9)
  1. Histological scoring of pathological variables

    The histological changes in chronic gastritis include chronic inflammation, active inflammation, atrophy, and intestinal metaplasia, which are classified into four grades: none (0), mild (+), moderate (++), and severe (+++). Each variable is assigned a score based on its grade, with primary variables receiving higher scores: intestinal metaplasia and atrophy at grade 4 are scored as '0, 3, 6, 9 points'; secondary variables receive lower scores: chronic inflammation and activity at grade 4 are scored as '0, 1, 2, 3 points'. The total scores for each variable and the overall pathological score are compared before and after treatment.

    Measured: 24 weeks after the start of treatment.

  2. Serum pepsinogen I and II (pepsinogen I, pepsinogen II, PG I, PG II), serum pepsinogen ratio (PGR), and gastrin-17 (Gastrin-17) levels.

    Serum pepsinogen levels are an important indicator of dynamic changes in gastric mucosal function. Measurement of PGⅠ, PGⅡ, PGR, and G-17 aids in assessing the extent and severity of gastric mucosal atrophy, and is referred to as 'serological biopsy.' In cases of gastric body atrophy, PGⅠ and PGR levels decrease, while G-17 levels increase; in cases of gastric antrum atrophy, G-17 levels decrease, and the PGⅠ to PGR ratio remains normal; in cases of total gastric atrophy, both levels decrease. Comparisons of serum markers before and after treatment are conducted.

    Measured: 24 weeks after the start of treatment.

  3. Global Overall Symptom (GOS) Score Change

    The Global Overall Symptom (GOS) score assesses eight symptoms associated with dyspepsia (e.g., epigastric pain, burning, fullness, early satiety, nausea, bloating). Scores range from 1 (no problem) to 7 (very severe problem). Scoring is as follows: 1 = no problem (no symptoms); 2 = minimal problem (can be easily ignored); 3 = mild problem (can be ignored with effort); 4 = moderate problem (cannot be ignored, but does not interfere with daily activities); 5 = moderately severe problem (cannot be ignored, occasionally limits daily activities); 6 = severe problem (cannot be ignored, often limits concentration on daily activities); 7 = very severe problem (cannot be ignored, severely limits daily activities.

    Measured: Baseline, Week 12, Week 24

  4. Hospital Anxiety and Depression Scale (HADS) Score Change

    The Hospital Anxiety and Depression Scale (HADS) measures levels of anxiety and depression, which are often associated with functional dyspepsia. Changes in HADS scores will be evaluated to determine if electroacupuncture has an impact on emotional well-being. The scores of anxiety and depression subscales are divided into: 0-7 points for no symptoms; 8-10 points for suspected presence; 11-21 points for definite presence; When scoring, 8 points is the starting point, that is, both suspected and symptomatic are positive.

    Measured: Baseline, Week 12, Week 24

  5. Visual analogue scale (VAS) score for upper abdominal pain

    Assess upper abdominal pain in subjects at weeks 0, 12, and 24. Patients mark the intensity of upper abdominal pain on a straight line from 0 (no pain) to 10 (most severe pain), which is suitable for rapid quantification of subjective pain perception.

    Measured: Baseline, Week 12, Week 24

  6. Upper abdominal pain diary

    Patients should record the frequency, duration, triggering factors (e.g., eating, stress), and accompanying symptoms (e.g., nausea, acid reflux) of each episode of upper abdominal pain during the entire treatment period. They should also record the types and doses of medications used to relieve upper abdominal pain (e.g., antacids, acid suppressants, antispasmodics, traditional Chinese medicines, etc.).

    Measured: Baseline to Week 24

  7. Pittsburgh Sleep Quality Index (PSQI)

    Assess the PSQI scores of the subjects at weeks 0, 12, and 24. This scale is the most commonly used scale for evaluating sleep quality in recent years. A PSQI score > 7 is considered to indicate poor sleep quality, while a PSQI score ≤ 7 is considered to indicate good sleep quality.

    Measured: Baseline, Week 12, Week 24

  8. Treatment Expectation Score

    Before treatment, patients are asked to assess their expectations of the efficacy of electroacupuncture. Patients are asked to evaluate the efficacy of electroacupuncture (electroacupuncture treatment will significantly improve my pathological condition) using a five-point scale: 'strongly agree,' 'somewhat agree,' 'neutral,' 'somewhat disagree,' and 'strongly disagree.' This is done to collect patients' expectations of electroacupuncture treatment.

    Measured: Prior to the first treatment (Baseline)

  9. Compliance evaluation

    Assess whether subjects at weeks 12 and 24 completed treatment and questionnaire collection at that point in time. If there are any withdrawals, exclusions, or dropouts during the study, promptly record the time of study termination and the specific reasons for termination.

    Measured: Baseline, Week 12, Week 24

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted3 Sep 2025
  2. Study start30 Dec 2025 (estimated)
  3. Primary completion30 Dec 2026 (estimated)
  4. Study completion30 Dec 2026 (estimated)

Resources

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
None (open label)
Enrolment
100 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT07152860
Sponsor's protocol ID
20250804103318839
Status last verified
Dec 2025
First submitted
26 Aug 2025
Last updated
19 Dec 2025
Results posted
No
Data monitoring committee
Yes
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
Yes

Questions about this trial

What is this clinical trial studying?

A study testing 5 Hz electroacupuncture combined tipronone capsules and Simple tipronone capsules group(The basic treatment group) in people with Chronic Atrophic Gastritis, run by Yi Liang 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 10 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 19 Dec 2025. 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 Yi Liang, Doctor (+86 571 86633328, liangyiwww@126.com), or a site near the patient. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Total pathological response rate after 24 weeks of intervention (time frame: 24 weeks after the start of treatment.). 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 19 Dec 2025.

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