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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
Active, not recruiting
Phases
Unknown
Study type
Interventional
Source
ITMCTR
Registry ID
ITMCTR2000003929
Enrollment
Unknown
Registered
2020-09-13
Start date
2020-10-01
Completion date
Unknown
Last updated
2023-02-20

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) Aged 18-70 years, male or female; (2) Those who meet the diagnostic criteria of chronic atrophic gastritis and the test for Helicobacter pylori is negative. (13C or 14C urea breath test is required); (3) The pathological stage is OLGA-II/III. Two experts from the Department of Pathology are required for diagnosis (Pathological film reading), whose pathological conclusion should reach an agreement; (4) Voluntarily participating in this clinical trial and signing informed consent.

Exclusion criteria

Exclusion criteria: (1) Patients with peptic ulcer, severe dysplasia of the gastric mucosa or pathological diagnosis suspected of malignant transformation; (2) Those who have severe digestive system diseases or used to have abdominal surgery; (3) Pregnant or lactating women; (4) In patients with severe heart and lung diseases , malignant tumor, severe DM and chronic liver and kidney dysfunction, ALT and AST of liver function damage were more than 1.5 times of the upper limit of normal, and renal function damage (BUN > 1.2 times of the upper limit of normal, Cr > the upper limit of normal); (5) PLT < 1.5 times of the lower limit of normal; (6) Disabled patients (blind, deaf, dumb, mental disorder, mental disorder, physical disability) as prescribed by law; (7) Alcoholics; (8) Those who are known to be allergic to two or more types of drugs or the ingredients of the drug and have allergic constitution; (9) Patients who participated in other clinical trials within 4 weeks. Patients who have taken Wifuchun, Moluodan and folic acid in within 2 weeks; (10) In the opinion of the investigator, those who will cause loss to follow-up, or not suitable for inclusion.

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