Status:
COMPLETED
To Evaluate the Efficacy and Safety of Vitamin B12 Contains Extract of Lamb's Stomach in Treatment of Chronic Atrophic Gastritis (CAG)
Lead Sponsor:
Xinjiang Biochemical Pharmaceutical Co., Ltd.
Conditions:
Chronic Atrophic Gastritis (CAG)
Eligibility:
All Genders
18-70 years
Phase:
PHASE4
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.
Eligibility Criteria
Inclusion
- Age 18-70 years, male or female
- Histologically diagnosed CAG
- HP negative confirmed by gastric mucosal staining
- Signed an written informed consent
Exclusion
- 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
Key Trial Info
Start Date :
August 1 2011
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
February 1 2013
Estimated Enrollment :
851 Patients enrolled
Trial Details
Trial ID
NCT01474044
Start Date
August 1 2011
End Date
February 1 2013
Last Update
July 9 2013
Active Locations (1)
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1
Xijing Hospital of Digestive Diseases
Xi’an, Shanxi, China, 710032