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

• Status: Completed
• Trial end date: 2013-02-01
• Target enrollment: 0
• Participant gender: All

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).

• Phase: Phase 4
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Xinjiang Biochemical Pharmaceutical Co., Ltd.
• Treatments: Hydroxocobalamin; Vitamin B 12; Vitamin B Complex

Criteria

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