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

July 6, 2013 updated by: Xinjiang Biochemical Pharmaceutical Co., Ltd.

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).

Study Overview

Status

Completed

Conditions

Intervention / Treatment

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 Type

Interventional

Enrollment (Actual)

851

Phase

  • Phase 4

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • China
    • Shanxi
      • Xi'an, Shanxi, China, 710032
        • Xijing Hospital of Digestive Diseases

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 70 years (ADULT, OLDER_ADULT)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: TREATMENT
  • Allocation: RANDOMIZED
  • Interventional Model: PARALLEL
  • Masking: QUADRUPLE

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
PLACEBO_COMPARATOR: Placebo
Other: Placebo Comparator
Placebo that is same as gastropyloric complex capsules
Other Names:
  • Placebo
ACTIVE_COMPARATOR: Gastropyloric Complex Capsules
Drug: Gastropylor Complex Capsules
3 pills, three times a day, after meal
Other Names:
  • Gastropyloric Extracts and Vit B12 Complex Capsules

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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.
within 180 days after treatment

Secondary Outcome Measures

Outcome Measure
Time Frame
clinical manifestations including abdominal pain, anorexia, nausea, vomiting, and belching
Time Frame: within 180 days after treatment
within 180 days after treatment

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Xinjiang Biochemical Pharmaceutical Co., Ltd.

Investigators

  • Principal Investigator: Kaichun WU, Professor, Xijing Hospital of Digestive Diseases

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

August 1, 2011

Primary Completion (ACTUAL)

February 1, 2013

Study Completion (ACTUAL)

February 1, 2013

Study Registration Dates

First Submitted

October 27, 2011

First Submitted That Met QC Criteria

November 14, 2011

First Posted (ESTIMATE)

November 17, 2011

Study Record Updates

Last Update Posted (ESTIMATE)

July 9, 2013

Last Update Submitted That Met QC Criteria

July 6, 2013

Last Verified

July 1, 2013

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • CATS-CO-002

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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