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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
ClinicalTrials.gov Identifier: NCT01474044
Recruitment Status : Completed
First Posted : November 17, 2011
Last Update Posted : July 9, 2013
Information provided by (Responsible Party):

Study Description
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).

Condition or disease Intervention/treatment Phase
Chronic Atrophic Gastritis (CAG) Drug: Gastropylor Complex Capsules Other: Placebo Comparator Phase 4

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.

Study Design

Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 851 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Official Title: 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
Study Start Date : August 2011
Primary Completion Date : February 2013
Study Completion Date : February 2013

Resource links provided by the National Library of Medicine

MedlinePlus related topics: B Vitamins
U.S. FDA Resources

Arms and Interventions

Arm Intervention/treatment
Placebo Comparator: Placebo Other: Placebo Comparator
Placebo that is same as gastropyloric complex capsules
Other Name: Placebo
Active Comparator: Gastropyloric Complex Capsules Drug: Gastropylor Complex Capsules
3 pills, three times a day, after meal
Other Name: Gastropyloric Extracts and Vit B12 Complex Capsules

Outcome Measures

Primary Outcome Measures :
  1. Effective rate confirmed by histology [ Time Frame: within 180 days after treatment ]
    All patients are required to repeat the histology examination after 180 days follow-up is completed.

Secondary Outcome Measures :
  1. clinical manifestations including abdominal pain, anorexia, nausea, vomiting, and belching [ Time Frame: within 180 days after treatment ]

Eligibility Criteria

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 70 Years   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No

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
Contacts and Locations

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01474044

China, Shanxi
Xijing Hospital of Digestive Diseases
Xi'an, Shanxi, China, 710032
Sponsors and Collaborators
Xinjiang Biochemical Pharmaceutical Co., Ltd.
Principal Investigator: Kaichun WU, Professor Xijing Hospital of Digestive Diseases
More Information

Responsible Party: Xinjiang Biochemical Pharmaceutical Co., Ltd.
ClinicalTrials.gov Identifier: NCT01474044     History of Changes
Other Study ID Numbers: CATS-CO-002
First Posted: November 17, 2011    Key Record Dates
Last Update Posted: July 9, 2013
Last Verified: July 2013

Additional relevant MeSH terms:
Gastritis, Atrophic
Pathological Conditions, Anatomical
Gastrointestinal Diseases
Digestive System Diseases
Stomach Diseases
Vitamin B Complex
Vitamin B 12
Growth Substances
Physiological Effects of Drugs