Trial | NCT01474044  Report issue

Title

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

  • Phase

    Phase 4

  • Study Type

    Interventional

  • Status

    Completed No Results Posted

  • Intervention/Treatment

    gastropylor complex ...

  • Study Participants

    851
The purpose of this study is to determine whether Gastropyloric Complex Capsules are safe and effective in the treatment of chronic atrophic gastritis (CAG).
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.
Study Started
Aug 31
2011
Primary Completion
Feb 28
2013
Study Completion
Feb 28
2013
Last Update
Jul 09
2013
Estimate

Drug Gastropylor Complex Capsules

3 pills, three times a day, after meal

  • Other names: Gastropyloric Extracts and Vit B12 Complex Capsules

Other Placebo Comparator

Placebo that is same as gastropyloric complex capsules

  • Other names: Placebo

Placebo Placebo Comparator

Gastropyloric Complex Capsules Active Comparator

Criteria 

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
No Results Posted