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A single-center, open-label clinical trial evaluating the efficacy and safety of Huajuhong in the treatment of Helicobacter pylori positive patients

A single-center, open-label clinical trial evaluating the efficacy and safety of Huajuhong in the treatment of Helicobacter pylori positive patients

Status
Active, not recruiting
Phases
Unknown
Study type
Interventional
Source
ChiCTR
Registry ID
ChiCTR2300076216
Enrollment
Unknown
Registered
2023-09-27
Start date
2022-07-25
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

Helicobacter pylori-associate gastritis

Interventions

Experimental group:Huajuhong powder

Sponsors

Guangzhou University of Chinese Medicine First Affiliated Hospital
Lead Sponsor

Eligibility

Sex/Gender
All
Age
18 Years to 65 Years

Inclusion criteria

Inclusion criteria: 1. Age 18 years old = Age = 65 years old; 2. Confirmed Hp infection by urea breath test; 3. Meets the diagnostic criteria for chronic non-atrophic gastritis according to the "Primary Care Guidelines for Chronic Gastritis (Practical Edition · 2019)"; 4. Diagnosed with dyspepsia and damp-heat pattern in spleen and stomach according to Traditional Chinese Medicine; 5. Upper abdominal distension VAS score > 4 points; 6. Subjects voluntarily sign an informed consent form.

Exclusion criteria

Exclusion criteria: 1. Patients who have used antibiotics, bismuth preparations, or PPIs or H2 receptor antagonists within 2 weeks before treatment, or 4 weeks before treatment. 2. Patients with moderate to severe atrophic gastritis, intestinal metaplasia, peptic ulcer, gastric cancer, esophageal cancer, gastric bleeding, biliary, pancreatic, or other serious digestive system diseases. 3. Patients with known allergy to any components in the study drug. 4. Patients with other cancers, malignant tumors, or serious primary diseases of the heart, brain, blood vessels, liver, kidneys, and hematopoietic system. 5. Patients planning to take corticosteroids or non-steroidal anti-inflammatory drugs for a long term. 6. Pregnant, planning to become pregnant, or breastfeeding women. 7. Patients who have participated in other clinical trials within the past 3 months. 8. Patients suspected of alcohol or drug abuse or those deemed unsuitable for this study by the researcher.

Design outcomes

Primary

MeasureTime frame
The proportion of subjects with Hp (-) after 4 weeks of drug discontinuation;

Secondary

MeasureTime frame
VAS score for upper abdominal distension;Clinical symptom score;The proportion of subjects with HP(-);The HP test value;

Countries

China

Contacts

Public ContactLi Peiwu

Guangzhou University of Chinese Medicine First Affiliated Hospital

doctorlipw@gzucm.edu.cn+86 189 2615 4883

Outcome results

None listed

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