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A randomized controlled trial of self-formulated Jiuwei Xiexin Decoction for chronic gastritis

A randomized controlled trial of self-formulated Jiuwei Xiexin Decoction for chronic gastritis

Status
Active, not recruiting
Phases
Unknown
Study type
Interventional
Source
ITMCTR
Registry ID
ITMCTR2026001655
Enrollment
Unknown
Registered
2026-07-06
Start date
2026-07-05
Completion date
Unknown
Last updated
2026-08-03

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Chronic gastritis

Interventions

Intervention group:Quadruple therapy + Jiuwei Xiexin Decoction. Quadruple therapy: proton pump inhibitor (omeprazole 30 mg once daily) + bismuth agent (bismuth potassium citrate 0.24 g four times dail
Control group:Quadruple therapy: proton pump inhibitor (omeprazole 30 mg once daily) + bismuth agent (bismuth potassium citrate 0.24 g four times daily) + two antibiotics (amoxicillin 0.5 g twice dail

Sponsors

Institute of Clinical Basic Medicine, China Academy of Chinese Medical Sciences
Lead Sponsor

Eligibility

Sex/Gender
All
Age
18 Years to 75 Years

Inclusion criteria

Inclusion criteria: 1.Meet the Western diagnostic criteria for chronic gastritis and the Traditional Chinese Medicine (TCM) diagnostic criteria for spleen-stomach damp-heat syndrome; 2.Aged 18 to 75 years; 3. Current positive for Helicobacter pylori (Hp); 4. Sign the informed consent form.

Exclusion criteria

Exclusion criteria: 1. Presence of peptic ulcer or upper gastrointestinal bleeding; 2. High-grade intraepithelial neoplasia or malignant transformation of the gastric mucosa; 3. Requirement for long-term use of non-steroidal anti-inflammatory drugs (NSAIDs); 4. Pregnant or breastfeeding women; 5. Use of anticholinergic agents, prokinetics, or other medications that may affect gastrointestinal function within the past 2 weeks; 6. Presence of severe organic diseases (e.g., heart, brain, liver, kidney, lung, or hematologic system disorders); 7. Diagnosed with mental illness or unable to actively cooperate with the trial procedures; 8. Currently participating in other drug clinical trials; 9. Any condition that, in the investigator's judgment, makes the participant unsuitable for enrollment.

Design outcomes

Primary

MeasureTime frame
Helicobacter pylori (Hp) eradication rate;

Secondary

MeasureTime frame
Response rate of improvement in total target symptom score;Response rate of improvement for individual symptoms;Time to symptom resolution;TCM syndrome efficacy evaluation;Gastric function tests;Patient quality of life assessment;

Countries

China

Contacts

Public Contactyinxiuping

Institute of Clinical Basic Medicine, China Academy of Chinese Medical Sciences

1787822087@qq.com17888808661

Outcome results

None listed

Source: ITMCTR (via WHO ICTRP) · Data processed: Aug 10, 2026