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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)

This study is currently recruiting participants.
Verified November 2011 by Xinjiang Biochemical Pharmaceutical Co., Ltd.
Sponsor:
Information provided by (Responsible Party):
Xinjiang Biochemical Pharmaceutical Co., Ltd.
ClinicalTrials.gov Identifier:
NCT01474044
First received: October 27, 2011
Last updated: March 27, 2012
Last verified: November 2011
History of Changes
  Purpose

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 Intervention Phase
Chronic Atrophic Gastritis (CAG)
 Drug: Gastropylor Complex Capsules
Other: Placebo Comparator
 Phase 4

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Caregiver, 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

Resource links provided by NLM:

U.S. FDA Resources

Further study details as provided by Xinjiang Biochemical Pharmaceutical Co., Ltd.:

Primary Outcome Measures:
  • 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.


Secondary Outcome Measures:
  • clinical manifestations including abdominal pain, anorexia, nausea, vomiting, and belching [ Time Frame: within 180 days after treatment ] [ Designated as safety issue: No ]

Estimated Enrollment: 855
Study Start Date: August 2011
Estimated Study Completion Date: November 2012
Estimated Primary Completion Date: May 2012 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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

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.

  Eligibility

Ages Eligible for Study:   18 Years to 70 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
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
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT01474044

Contacts
Contact: Na LIU, MD 86-29-84771506 liuzhp@fmmu.edu.cn

Locations
China, Shanxi
Xijing Hospital of Digestive Diseases Recruiting
Xi'an, Shanxi, China, 710032
Contact: Na LIU, MD     86-29-84771506     liuzhp@fmmu.edu.cn    
Sponsors and Collaborators
Xinjiang Biochemical Pharmaceutical Co., Ltd.
Investigators
Principal Investigator: Kaichun WU, Professor Xijing Hospital of Digestive Diseases
  More Information

No publications provided

Responsible Party: Xinjiang Biochemical Pharmaceutical Co., Ltd.
ClinicalTrials.gov Identifier: NCT01474044     History of Changes
Other Study ID Numbers: CATS-CO-002
Study First Received: October 27, 2011
Last Updated: March 27, 2012
Health Authority: China: Food and Drug Administration

Additional relevant MeSH terms:
Gastritis
Gastritis, Atrophic
Atrophy
Gastroenteritis
Gastrointestinal Diseases
Digestive System Diseases
Stomach Diseases
Pathological Conditions, Anatomical
Vitamin B 12
Hydroxocobalamin
 Vitamins
Vitamin B Complex
Micronutrients
Growth Substances
Physiological Effects of Drugs
Pharmacologic Actions
Hematinics
Hematologic Agents
Therapeutic Uses

ClinicalTrials.gov processed this record on June 13, 2013