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

NCT07152860 | Not Yet Recruiting DMC

• 1 other identifier: 20250804103318839
• Study Type: interventional
• Target: 100
• Locations: 1 country
• Sites: 3

Brief 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. The primary objectives of this study are to answer the following questions:

• 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.

Conditions

Chronic Atrophic Gastritis

Keywords

Chronic atrophic gastritis; electroacupuncture

Outcome Measures

Primary Outcomes (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.

  24 weeks after the start of treatment.

Secondary Outcomes (9)

• Histological scoring of pathological variables

  24 weeks after the start of treatment.

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

  24 weeks after the start of treatment.

• Global Overall Symptom (GOS) Score Change

  Baseline, Week 12, Week 24

• Hospital Anxiety and Depression Scale (HADS) Score Change

  Baseline, Week 12, Week 24

• Visual analogue scale (VAS) score for upper abdominal pain

  Baseline, Week 12, Week 24

Study Arms (2)

Electroacupuncture combined with tipronone capsules group

EXPERIMENTAL

Participants 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.

Other: 5 Hz electroacupuncture combined tipronone capsules

Simple tipronone capsules group(The basic treatment group)

ACTIVE COMPARATOR

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. Treatment will be continued for 24 weeks.

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

Interventions

5 Hz electroacupuncture combined tipronone capsules OTHER

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.

Electroacupuncture combined with tipronone capsules group

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.

Simple tipronone capsules group(The basic treatment group)

Eligibility Criteria

• Age: 18 Years - 75 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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;
• 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.

Sponsors & Collaborators

• Yi Liang: lead
• Zhejiang Provincial Department of Science and Technology: collaborator

Study Sites (3)

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

Hangzhou, Zhejiang, 310007, China

Location

Hangzhou First People's Hospital

Hangzhou, Zhejiang, 310053, China

Location

The Third Affiliated Hospital of Zhejiang Chinese Medicinal University

Hangzhou, Zhejiang, 310053, China

Location

MeSH Terms

Conditions

Gastritis, Atrophic

Condition Hierarchy (Ancestors)

Gastritis; Gastroenteritis; Gastrointestinal Diseases; Digestive System Diseases; Stomach Diseases

Central Study Contacts

Yi Liang, Doctor

CONTACT

+86 571 86633328; liangyiwww@126.com

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR INVESTIGATOR
• PI Title: Research Fellow

Study Record Dates

• First Submitted: August 26, 2025
• First Posted: September 3, 2025
• Study Start: December 30, 2025
• Primary Completion (Estimated): December 30, 2026
• Study Completion (Estimated): December 30, 2026
• Last Updated: December 19, 2025

Record last verified: 2025-12

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL, SAP, ICF

Locations

CN (3)