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

Xinjiang Biochemical Pharmaceutical

Status and phase

Completed

Phase 4

Conditions

Chronic Atrophic Gastritis (CAG)

Treatments

Other: Placebo Comparator

Drug: Gastropylor Complex Capsules

Study type

Interventional

Funder types

Industry

Identifiers

NCT01474044

CATS-CO-002

Details and patient eligibility

About

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

Full 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.

Enrollment

851 patients

Sex

All

Ages

18 to 70 years old

Volunteers

No 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