To Evaluate the Efficacy and Safety of Vitamin B12 Contains Extract of Lamb's Stomach in Treatment of Chronic Atrophic Gastritis (CAG)

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Xinjiang Biochemical Pharmaceutical Co., Ltd.
ClinicalTrials.gov Identifier:
NCT01474044
First received: October 27, 2011
Last updated: July 6, 2013
Last verified: July 2013

October 27, 2011
July 6, 2013
August 2011
February 2013   (final data collection date for primary outcome measure)
Effective rate confirmed by histology [ Time Frame: within 180 days after treatment ] [ Designated as safety issue: Yes ]
All patients are required to repeat the histology examination after 180 days follow-up is completed.
Same as current
Complete list of historical versions of study NCT01474044 on ClinicalTrials.gov Archive Site
clinical manifestations including abdominal pain, anorexia, nausea, vomiting, and belching [ Time Frame: within 180 days after treatment ] [ Designated as safety issue: No ]
Same as current
Not Provided
Not Provided
 
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

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.

Interventional
Phase 4
Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Chronic Atrophic Gastritis (CAG)
  • Drug: Gastropylor Complex Capsules
    3 pills, three times a day, after meal
    Other Name: Gastropyloric Extracts and Vit B12 Complex Capsules
  • Other: Placebo Comparator
    Placebo that is same as gastropyloric complex capsules
    Other Name: Placebo
  • Placebo Comparator: Placebo
    Intervention: Other: Placebo Comparator
  • Active Comparator: Gastropyloric Complex Capsules
    Intervention: Drug: Gastropylor Complex Capsules
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
851
February 2013
February 2013   (final data collection date for primary outcome measure)

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
Both
18 Years to 70 Years
No
Contact information is only displayed when the study is recruiting subjects
China
 
NCT01474044
CATS-CO-002
No
Xinjiang Biochemical Pharmaceutical Co., Ltd.
Xinjiang Biochemical Pharmaceutical Co., Ltd.
Not Provided
Principal Investigator: Kaichun WU, Professor Xijing Hospital of Digestive Diseases
Xinjiang Biochemical Pharmaceutical Co., Ltd.
July 2013

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP