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Completed

NCT Number: NCT01474044

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

The purpose of this study is to determine whether Gastropyloric Complex Capsules are safe and effective in the treatment of chronic atrophic gastritis (CAG).

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Key information

Conditions

Chronic Atrophic Gastritis (CAG) Digestive System Diseases Gastritis Gastritis, Atrophic Gastroenteritis Gastrointestinal Diseases Stomach Diseases

Age range

18 year–70 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 4

Primary location

Xijing Hospital of Digestive Diseases

Xi’an, Shanxi, 710032, China

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Gastropylor Complex Capsules

Drug

3 pills, three times a day, after meal

Other names: Gastropyloric Extracts and Vit B12 Complex Capsules

Placebo Comparator

Other

Placebo that is same as gastropyloric complex capsules

Other names: Placebo

Primary outcomes

  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 outcomes

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

    Time frame: within 180 days after treatment

Sponsors and collaborators

Lead sponsor

Xinjiang Biochemical Pharmaceutical Co., Ltd.

Industry

Registry information

Official study 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

Important dates

Study start
2011
Primary completion
2013
Study completion
2013
First posted
Nov 17, 2011
Registry last updated
Jul 9, 2013

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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