To Evaluate the Efficacy and Safety of Vitamin B12 Contains Extract of Lamb's Stomach in Treatment of Chronic Atrophic Gastritis (CAG)
Phase 4
Completed
- Conditions
- Chronic Atrophic Gastritis (CAG)
- Interventions
- Drug: Gastropylor Complex CapsulesOther: Placebo Comparator
- Registration Number
- NCT01474044
- Lead Sponsor
- Xinjiang Biochemical Pharmaceutical Co., Ltd.
- 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.
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 851
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
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description Gastropyloric Complex Capsules Gastropylor Complex Capsules - Placebo Placebo Comparator -
- Primary Outcome Measures
Name Time Method 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 Outcome Measures
Name Time Method clinical manifestations including abdominal pain, anorexia, nausea, vomiting, and belching within 180 days after treatment
Trial Locations
- Locations (1)
Xijing Hospital of Digestive Diseases
🇨🇳Xi'an, Shanxi, China