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Clinical Study on the Treatment of Low grade Gastric Intraepithelial Neoplasia by Regulating the Gastric Environment with Eqi Shicao Tang Based on Metabolomics Exploration

Clinical Study on the Treatment of Low grade Gastric Intraepithelial Neoplasia by Regulating the Gastric Environment with Eqi Shicao Tang Based on Metabolomics Exploration

Status
Recruiting
Phases
Early Phase 1
Study type
Interventional
Source
ChiCTR
Registry ID
ChiCTR2300076131
Enrollment
Unknown
Registered
2023-09-26
Start date
2023-09-26
Completion date
Unknown
Last updated
2023-10-03

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

Conditions

Low grade intraepithelial neoplasia of the stomach

Interventions

Treatment group:On the basis of symptomatic treatment with conventional Western medicine,oral Chinese herbal decoction (composed of Curcuma zedoary, Astragalus membranaceus, raw Coix seed, premedicate
control group:symptomatic treatment with conventional Western medicine

Sponsors

Fengxian People's Hospital
Lead Sponsor

Eligibility

Sex/Gender
All
Age
18 Years to 75 Years

Inclusion criteria

Inclusion criteria: 1) Confirmed by gastroscopy and histopathology as chronic gastritis with low-level intraepithelial tumors, with or without atrophy and intestinal metaplasia; 2) Age range from 18 to 75 years old (including upper and lower limits), regardless of gender; 3) The patient understands and understands the study protocol and signs a written informed consent form.

Exclusion criteria

Exclusion criteria: 1) Patients with a lesion range exceeding 2cm, including peptic ulcers, upper gastrointestinal bleeding, and low-level intraepithelial neoplasia, as well as those with high-level intraepithelial neoplasia or gastric cancer; 2) Individuals with a history of gastric surgery; 3) Individuals with severe liver and kidney dysfunction, i.e. alanine transferase (ALT) and aspartate transferase (AST), are greater than or equal to the upper limit of 3 normal values (3ULN); Alkaline phosphatase (ALP) = 2 ULN; Total bilirubin (TBIL) greater than 1.5 ULN;; Serum creatinine (CR) greater than 1.5ULN or creatinine clearance rate (CCR) less than 80 ml/min. If one of the above exists; 4) Long term use of non-steroidal anti-inflammatory drugs, hormones, proton pump inhibitors, H2 receptor blockers, and other treatments; 5) Digestive system diseases such as chronic pancreatitis and liver cirrhosis, or systemic diseases such as hyperthyroidism that affect gastrointestinal motility; 6) Patients with severe organic damage to the heart, lungs, brain, and blood system, patients with other organ tumors, and patients with mental illness; 7) Pregnant and lactating women; 8) Individuals with severe allergic constitution who are allergic to the drugs in this study; 9) Participated in other clinical trials in the past 2 months; 10) The researcher believes that there are any other circumstances that are not suitable for participation in this study

Design outcomes

Primary

MeasureTime frame
Overall effective rate of gastric mucosal histopathology score;

Secondary

MeasureTime frame
Effective rate of integrating mucosal signs under gastroscopy;Clinical syndrome efficacy score effective rate;

Countries

China

Contacts

Public ContactJiang Zhenzhen

Fengxian People's Hospital

1137927314@qq.com+86 158 6219 9210

Outcome results

None listed

Source: ChiCTR (via WHO ICTRP) · Data processed: Feb 4, 2026