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Randomized controlled clinical study on the treatment of OLGA stage III/IV chronic atrophic gastritis with Shenqi Zhonghe Granules

Randomized controlled clinical study on the treatment of OLGA stage III/IV chronic atrophic gastritis with Shenqi Zhonghe Granules

Status
Recruiting
Phases
Unknown
Study type
Interventional
Source
ITMCTR
Registry ID
ITMCTR2026000516
Enrollment
Unknown
Registered
2026-03-13
Start date
2025-02-22
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

Chronic atrophic gastritis

Interventions

experimental group:Shenqi Zhonghe Granules + Folic Acid Tablet Simulator
control group:Shenqi Zhonghe Granules Simulator + Folic Acid Tablets

Sponsors

Eye Hospital of China Academy of Chinese Medical Sciences
Lead Sponsor

Eligibility

Sex/Gender
All
Age
18 Years to 70 Years

Inclusion criteria

Inclusion criteria: (1) CAG patients diagnosed with OLGA stage III/IV based on histopathological examination; (2) Patients with a combined syndrome of spleen-stomach qi deficiency and stomach collateral blood stasis as diagnosed based on traditional Chinese medicine (TCM) differentiation; (3) Helicobacter pylori test negative; (4) Aged between 18 and 70; (5) The subjects are informed and voluntarily sign the informed consent form.

Exclusion criteria

Exclusion criteria: (1) Patients with combined peptic ulcer, moderate or severe dysplasia, or suspected malignant pathology; (2) Those with severe digestive system diseases or a history of abdominal surgery; (3) Those who have been taking NSAIDs for a long time; (4) Patients with severe primary diseases such as heart, lung, hematopoietic system, and malignant tumors, severe diabetes, and chronic liver and kidney dysfunction (ALT > 1.5 times the upper limit of normal value, blood Gr > 1.5 times the upper limit of normal value); (5) Women who are pregnant, planning to become pregnant, or breastfeeding; (6) Individuals with mental illnesses, intellectual disabilities, or language impairments; (7) Individuals with allergic constitution or a history of allergy to known ingredients in the study drug; (8) According to the researchers' judgment, those who are prone to loss to follow-up or are otherwise unsuitable for enrollment.

Design outcomes

Primary

MeasureTime frame
Pathological improvement rate of gastric mucosal atrophy;Operative Link for Gastritis Assessment (OLGA) improvement rate;

Secondary

MeasureTime frame
Improvement rate of other gastric mucosal pathologies (intestinal metaplasia, chronic inflammation, active inflammation);Operative Link on Gastric Intestinal Metaplasia Assessment(OLGIM) improvement rate;Gastroscopy-based mucosal lesion scores;Pepsinogen(PG)I/II and Gastrin 17 ;Clinical symptom scores;

Countries

China

Contacts

Public ContactYandong WEN

Eye Hospital of China Academy of Chinese Medical Sciences

wen6120@126.com13717902281

Outcome results

None listed

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