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Clinical Observation on the Efficacy of Modified Banxia Xiexin Decoction for Artificial Ulcers of the Cold-Heat Complex Pattern after Endoscopic Submucosal Dissection

Clinical Observation on the Efficacy of Modified Banxia Xiexin Decoction for Artificial Ulcers of the Cold-Heat Complex Pattern after Endoscopic Submucosal Dissection

Status
Active, not recruiting
Phases
Unknown
Study type
Interventional
Source
ITMCTR
Registry ID
ITMCTR2026000705
Enrollment
Unknown
Registered
2026-03-24
Start date
2024-05-01
Completion date
Unknown
Last updated
2026-03-30

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

Conditions

Artificial ulcer

Interventions

Control Group:Oral esomeprazole magnesium enteric-coated dry suspension (BEMEI Pharmaceutical Co., Ltd., Shenzhen, National Medical Products Administration Approval No. HJ20233134), 20 mg twice dail
Treatment Group:In addition to the treatment for the control group, patients were also administered the modified Banxia Xiexin Decoction.

Sponsors

Lishui Hospital of Traditional Chinese Medicine affiliated to Zhejiang University of Chinese Medicine
Lead Sponsor

Eligibility

Sex/Gender
All
Age
18 Years to 75 Years

Inclusion criteria

Inclusion criteria: (1) Age: 18-75 years old; (2) Diagnosed with early esophageal cancer, gastric cancer or precancerous lesions through gastroscopy and pathology, and successfully underwent ESD surgery; (3) Postoperative gastroscopy confirmed the presence of an unclosed artificial ulcer. (4) Comply with the syndrome differentiation criteria for the mixed cold and heat type as stipulated in the "Consensus on the Integrated Traditional Chinese and Western Medicine Diagnosis and Treatment of Peptic Ulcer (2017)". (5) Sign the informed consent form.

Exclusion criteria

Exclusion criteria: (1) Allergic to the research drug (a traditional Chinese medicine composed of esomeprazole and Banxia Xiexin Decoction); (2) Postoperative pathology indicates a positive resection margin or infiltration depth exceeding the submucosa; (3) Combined with severe heart, liver or kidney insufficiency; (4) Pregnant or lactating women; (5) Long-term use of non-steroidal anti-inflammatory drugs or anticoagulant drugs; (6) Combined with other severe digestive system diseases or systemic diseases.

Design outcomes

Primary

MeasureTime frame
The total clinical effective rate after 8 weeks of treatment;

Secondary

MeasureTime frame
Changes in TCM syndrome points;Ulcer healing rate, proportion of S2 stage healing;Average length of hospital stay and treatment cost;

Countries

china

Contacts

Public Contactwu jianye

Lishui Hospital of Traditional Chinese Medicine affiliated to Zhejiang University of Chinese Medicine

equest@163.com13757860187

Outcome results

None listed

Source: ITMCTR (via WHO ICTRP) · Data processed: Apr 4, 2026