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CompletedNCT01474044Updated Jul 9, 2013

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

A Phase 4 interventional study of Gastropylor Complex Capsules and Placebo Comparator in Chronic Atrophic Gastritis (CAG), sponsored by Xinjiang Biochemical Pharmaceutical Co., Ltd.. Completed at 1 site in China. Open to participants aged 18 Years to 70 Years. Per ClinicalTrials.gov, last updated 2013-07-09.

Sponsored by Xinjiang Biochemical Pharmaceutical Co., Ltd. · Phase 4, Interventional, and Treatment

Phase
Phase 4
Study type
Interventional
Enrollment
851
Allocation
Randomized
Ages
18 Years to 70 Years
Sex
All
01

Study 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).

Read the 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.

02

Conditions studied

  • Chronic Atrophic Gastritis (CAG)
03

In context

Gastritis

196 studies on the registry are indexed under Gastritis; 42 are open to participants now.

This study's enrollment of 851 is above the median of 200 across 113 interventional studies indexed under Gastritis.

Browse Gastritis studies →

Lead sponsor

This is the only study on the registry with Xinjiang Biochemical Pharmaceutical Co., Ltd. as lead sponsor.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
18 Years to 70 Years
Sexes eligible
All
Accepts healthy volunteers
No

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

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
05

Study design

Phase
Phase 4
Primary purpose
Treatment
Allocation
Randomized
Intervention model
Parallel assignment
Masking
Quadruple (Participant, Care provider, Investigator, Outcomes assessor)
Enrollment
851 participants (actual)

Study arms

  • Placebo comparator
    Placebo

    Other: Placebo Comparator

  • Active comparator
    Gastropyloric Complex Capsules

    Drug: Gastropylor Complex Capsules

Interventions

  • DrugGastropylor Complex Capsules

    3 pills, three times a day, after meal

    Also known as: Gastropyloric Extracts and Vit B12 Complex Capsules

  • OtherPlacebo Comparator

    Placebo that is same as gastropyloric complex capsules

    Also known as: Placebo

06

What researchers measure

Primary outcomes

  1. Effective rate confirmed by histology

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

    Time frame: within 180 days after treatment

Secondary outcomes

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

    Time frame: within 180 days after treatment

07

Study locations

1 site
  • Xijing Hospital of Digestive Diseases
    Xi'an, Shanxi 710032, China
08

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Jul 9, 2013, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
09

Registry details

Key details

Study ID
NCT01474044
Lead sponsor
Xinjiang Biochemical Pharmaceutical Co., Ltd.
Responsible party
Sponsor
First posted
Nov 17, 2011
Start date
Aug 2011
Primary completion
Feb 2013
Completion
Feb 2013
Last update
Jul 9, 2013

Study contacts

Kaichun WU, Professor
principal investigator · Xijing Hospital of Digestive Diseases

Oversight

Data monitoring committee
No
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is completed, as verified in Jul 2013. You cannot join it, but the record below documents what was studied.

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