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

Chronic Atrophic Gastritis (CAG) Clinical Trial

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01474044
• Other study ID #: CATS-CO-002
• Status: Completed
• Phase: Phase 4
• First received: October 27, 2011
• Last updated: July 6, 2013
• Start date: August 2011
• Est. completion date: February 2013

Study information

• Verified date: July 2013
• Source: Xinjiang Biochemical Pharmaceutical Co., Ltd.
• Contact: n/a
• Is FDA regulated: No
• Health authority: China: Food and Drug Administration
• Study type: Interventional

Clinical Trial 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).

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 851
• Est. completion date: February 2013
• Est. primary completion date: February 2013
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years to 70 Years

Eligibility

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 Design

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor), Primary Purpose: Treatment

Related Conditions & MeSH terms

• Atrophy
• Chronic Atrophic Gastritis (CAG)
• Gastritis
• Gastritis, Atrophic

Intervention

Drug:
• Gastropylor Complex Capsules
3 pills, three times a day, after meal

Other:
• Placebo Comparator
Placebo that is same as gastropyloric complex capsules

Locations

Country	Name	City	State
China	Xijing Hospital of Digestive Diseases	Xi'an	Shanxi

Sponsors (1)

Lead Sponsor	Collaborator
Xinjiang Biochemical Pharmaceutical Co., Ltd.

Country where clinical trial is conducted

China, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Effective rate confirmed by histology	All patients are required to repeat the histology examination after 180 days follow-up is completed.	within 180 days after treatment	Yes
Secondary	clinical manifestations including abdominal pain, anorexia, nausea, vomiting, and belching		within 180 days after treatment	No