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Effect and Safety of Elian Granules for the Treatment of Chronic Atrophic Gastritis: a Randomized, Double-Blind, Placebo-Controlled, Multicenter Trial

Effect and Safety of Elian Granules for the Treatment of Chronic Atrophic Gastritis: a Randomized, Double-Blind, Placebo-Controlled, Multicenter Trial

Status
Recruiting
Phases
Unknown
Study type
Interventional
Source
ChiCTR
Registry ID
ChiCTR2000038207
Enrollment
Unknown
Registered
2020-09-13
Start date
2020-10-01
Completion date
Unknown
Last updated
2020-11-30

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

Conditions

Chronic Atrophic Gastritis

Interventions

Sponsors

Shuguang Hospital affiliated to Shanghai University of Traditional Chinese Medicine
Lead Sponsor

Eligibility

Sex/Gender
All
Age
18 Years to 70 Years

Inclusion criteria

Inclusion criteria: 1. Patients aged from 18 to 70 years old, regardless of gender; 2. Patients who meet the diagnostic criteria of chronic atrophic gastritis and are negative for Helicobacter pylori (at least one 13C or 14C breath test is required); 3. The pathology belongs to Olga stage II and stage III. Two experts from the pathology department were required to make the diagnosis (pathological reading) of the patients, and the two experts had the same opinion; 4. Patients who voluntarily participate in this clinical trial should give informed consent and sign informed consent.

Exclusion criteria

Exclusion criteria: 1. Patients with peptic ulcer, severe dysplasia of gastric mucosa (high grade intraepithelial neoplasia) or suspected malignant lesions by pathological diagnosis; 2. Patients with severe digestive system diseases or history of abdominal surgery; 3. Pregnant and lactating women; 4. Patients with severe heart, lung, hematopoietic system, malignant tumor and other primary diseases, severe diabetes mellitus, chronic liver and kidney dysfunction, in which ALT of liver function damage is more than 1.5 times of the upper limit of normal value, and serum creatinine (CR) of renal function damage is 1.5 times of the upper limit of normal value; 5. The patients whose platelets were lower than 1.5 times of the lower limit of normal value; 6. Patients with disabilities prescribed by law (blindness, deafness, dumb, mental retardation, mental disorder and physical disability); 7. Patients with history of alcoholism; 8. Patients with allergic constitution or history of allergy to multiple drugs (more than two or known ingredients in the drug); 9. Patients who have participated in clinical trials of other drugs in the past 4 weeks; or those who have used preparations such as Weifuchun, morodan and folic acid in the past 2 weeks; and; 10. According to the researcher's judgment, it is easy to lose the interview or other reasons that are not suitable for selection.

Design outcomes

Primary

MeasureTime frame
Gastroscopy and Gastric mucosal biopcy;

Secondary

MeasureTime frame
Indigestion symptom checklist;12-item short-form health survey, SF-12;

Countries

China

Contacts

Public ContactLing Jianghong

Shuguang Hospital affiliated to Shanghai University of Traditional Chinese Medicine

459183870@qq.com+86 18817424778

Outcome results

None listed

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