To Evaluate the Efficacy and Safety of Vitamin B12 Contains Extract of Lamb's Stomach in Treatmen… (NCT01474044) | Clinical Trial Compass
CompletedPhase 4
To Evaluate the Efficacy and Safety of Vitamin B12 Contains Extract of Lamb's Stomach in Treatment of Chronic Atrophic Gastritis (CAG)
China851 participantsStarted 2011-08
Plain-language 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).
Who can participate
Age range
18 Years – 70 Years
Sex
ALL
See this in plain English?
AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
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
Questions worth asking your doctor
Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.
1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?
Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.
Questions for the trial coordinator
The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.
1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?
A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.