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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)

Primary Purpose

Chronic Atrophic Gastritis (CAG)

Status

Completed

Phase

Phase 4

Locations

China

Study Type

Interventional

Intervention

Gastropylor Complex Capsules

Placebo Comparator

About this trial

This is an interventional treatment trial for Chronic Atrophic Gastritis (CAG)

Eligibility Criteria

18 Years - 70 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

Xijing Hospital of Digestive Diseases

Arms of the Study

Arm 1

Arm 2

Arm Type

Placebo Comparator

Active Comparator

Arm Label

Placebo

Gastropyloric Complex Capsules

Arm Description

Outcomes

Primary Outcome Measures

Effective rate confirmed by histology

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

Full Information

NCT ID

NCT01474044

First Posted

October 27, 2011

Last Updated

July 6, 2013

Sponsor

Xinjiang Biochemical Pharmaceutical Co., Ltd.

1. Study Identification

Unique Protocol Identification Number

NCT01474044

Brief Title

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

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 Type

Interventional

2. Study Status

Record Verification Date

July 2013

Overall Recruitment Status

Completed

Study Start Date

August 2011 (undefined)

Primary Completion Date

February 2013 (Actual)

Study Completion Date

February 2013 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Sponsor

Name of the Sponsor

Xinjiang Biochemical Pharmaceutical Co., Ltd.

4. Oversight

Data Monitoring Committee

5. 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).

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Chronic Atrophic Gastritis (CAG)

7. Study Design

Primary Purpose

Treatment

Study Phase

Phase 4

Interventional Study Model

Parallel Assignment

Masking

ParticipantCare ProviderInvestigatorOutcomes Assessor

Allocation

Randomized

Enrollment

851 (Actual)

8. Arms, Groups, and Interventions

Arm Title

Placebo

Arm Type

Placebo Comparator

Arm Title

Gastropyloric Complex Capsules

Arm Type

Active Comparator

Intervention Type

Drug

Intervention Name(s)

Gastropylor Complex Capsules

Other Intervention Name(s)

Gastropyloric Extracts and Vit B12 Complex Capsules

Intervention Description

3 pills, three times a day, after meal

Intervention Type

Other

Intervention Name(s)

Placebo Comparator

Other Intervention Name(s)

Placebo

Intervention Description

Placebo that is same as gastropyloric complex capsules

Primary Outcome Measure Information:

Title

Effective rate confirmed by histology

Description

All patients are required to repeat the histology examination after 180 days follow-up is completed.

Time Frame

within 180 days after treatment

Secondary Outcome Measure Information:

Title

clinical manifestations including abdominal pain, anorexia, nausea, vomiting, and belching

Time Frame

within 180 days after treatment

10. Eligibility

Sex

All

Minimum Age & Unit of Time

18 Years

Maximum Age & Unit of Time

70 Years

Accepts Healthy Volunteers

Eligibility 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

Overall Study Officials:

First Name & Middle Initial & Last Name & Degree

Kaichun WU, Professor

Organizational Affiliation

Xijing Hospital of Digestive Diseases

Official's Role

Principal Investigator

Facility Information:

Facility Name

Xijing Hospital of Digestive Diseases

City

Xi'an

State/Province

Shanxi

ZIP/Postal Code

710032

Country

China

12. IPD Sharing Statement

Learn more about this trial

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

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