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
1 other identifier
interventional
851
1 country
1
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).
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for phase_4
Started Aug 2011
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
Study Start
First participant enrolled
August 1, 2011
CompletedFirst Submitted
Initial submission to the registry
October 27, 2011
CompletedFirst Posted
Study publicly available on registry
November 17, 2011
CompletedPrimary Completion
Last participant's last visit for primary outcome
February 1, 2013
CompletedStudy Completion
Last participant's last visit for all outcomes
February 1, 2013
CompletedJuly 9, 2013
July 1, 2013
1.5 years
October 27, 2011
July 6, 2013
Conditions
Outcome Measures
Primary Outcomes (1)
Effective rate confirmed by histology
All patients are required to repeat the histology examination after 180 days follow-up is completed.
within 180 days after treatment
Secondary Outcomes (1)
clinical manifestations including abdominal pain, anorexia, nausea, vomiting, and belching
within 180 days after treatment
Study Arms (2)
Placebo
PLACEBO COMPARATORGastropyloric Complex Capsules
ACTIVE COMPARATORInterventions
3 pills, three times a day, after meal
Placebo that is same as gastropyloric complex capsules
Eligibility Criteria
You may qualify if:
- Age 18-70 years, male or female
- Histologically diagnosed CAG
- HP negative confirmed by gastric mucosal staining
- Signed an written informed consent
You may not qualify if:
- 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
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
Xijing Hospital of Digestive Diseases
Xi’an, Shanxi, 710032, China
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Kaichun WU, Professor
Xijing Hospital of Digestive Diseases
Study Design
- Study Type
- interventional
- Phase
- phase 4
- Allocation
- RANDOMIZED
- Masking
- QUADRUPLE
- Who Masked
- PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- INDUSTRY
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
October 27, 2011
First Posted
November 17, 2011
Study Start
August 1, 2011
Primary Completion
February 1, 2013
Study Completion
February 1, 2013
Last Updated
July 9, 2013
Record last verified: 2013-07