To Evaluate the Efficacy and Safety of Vitamin B12 Contains Extract of Lamb's Stomach in Treatment of Chronic Atrophic Gastritis (CAG)

A Phase IV Study to Evaluate the Efficacy and Safety of Vitamin B12 Contains Extract of Lamb's Stomach in Treatment of Chronic Atrophic Gastritis

Status

Completed

Phases

Phase 4

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT01474044

Enrollment

851

Registered

2011-11-17

Start date

2011-08-31

Completion date

2013-02-28

Last updated

2013-07-09

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

Conditions

Chronic Atrophic Gastritis (CAG)

Brief summary

The purpose of this study is to determine whether Gastropyloric Complex Capsules are safe and effective in the treatment of chronic atrophic gastritis (CAG).

Detailed description

Till now, there is no ideal treatment to chronic atrophic gastritis(CAG). This study is try to find a possible treatment to CAG with Gastropyloric Complex Capsules.

Interventions

DRUGGastropylor Complex Capsules

3 pills, three times a day, after meal

OTHERPlacebo Comparator

Placebo that is same as gastropyloric complex capsules

Study design

Allocation

RANDOMIZED

Intervention model

PARALLEL

Primary purpose

TREATMENT

Masking

QUADRUPLE (Subject, Caregiver, Investigator, Outcomes Assessor)

Eligibility

Sex/Gender

ALL

Age

18 Years to 70 Years

Healthy volunteers

Inclusion criteria

* Age 18-70 years, male or female * Histologically diagnosed CAG * HP negative confirmed by gastric mucosal staining * Signed an written informed consent

Exclusion criteria

* CAG with high-grade intraepithelial neoplasia * Severe gastric mucosal erosion or bleeding needing treatment * Active peptic ulcer, GERD, or esophageal stricture * History of upper GI tract surgery * History of malignant diseases * With depression, anxiety neuroses, or hysteria * Heart failure (NYHA class lll or lV), liver disease (ALT ≥ 80 IU/L, AST ≥ 80 IU/L) or renal disease(Cr ≥ 150 ummol/L) * Uncontrolled hypertension * Uncontrolled diabetes * Alcohol abuse * Drug allergy * Participated in another investigational study within 4 weeks prior to Visit 0 * Pregnancy, be a nursing mother or without conception control * There is any concern by the investigator regarding the safe participation of the participant in the study or for any other reason; the investigator considers the participant inappropriate for participation in the study

Design outcomes

Primary

Measure	Time frame	Description
Effective rate confirmed by histology	within 180 days after treatment	All patients are required to repeat the histology examination after 180 days follow-up is completed.

Secondary

Measure	Time frame
clinical manifestations including abdominal pain, anorexia, nausea, vomiting, and belching	within 180 days after treatment

Countries

China

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026