NCT02955134

Brief Summary

The purpose of this study is to evaluate efficacy of Chinese medicine treatment for chronic atrophic gastritis. It is a multi-center, randomized, placebo-controlled trial.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
468

participants targeted

Target at P75+ for not_applicable

Timeline
Completed

Started Mar 2018

Longer than P75 for not_applicable

Geographic Reach
1 country

13 active sites

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

October 28, 2016

Completed
7 days until next milestone

First Posted

Study publicly available on registry

November 4, 2016

Completed
1.4 years until next milestone

Study Start

First participant enrolled

March 12, 2018

Completed
3.1 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

May 1, 2021

Completed
7 months until next milestone

Study Completion

Last participant's last visit for all outcomes

November 30, 2021

Completed
Last Updated

March 11, 2022

Status Verified

February 1, 2022

Enrollment Period

3.1 years

First QC Date

October 28, 2016

Last Update Submit

February 24, 2022

Conditions

Chronic Atrophic Gastritis

Keywords

central blinded histological assessmenttraditional Chinese medicine interventionbiological specimen banks

Outcome Measures

Primary Outcomes (2)

  • Change of histological score

    Gastric mucosa samples are subsequently evaluated according to updated Sydney system with the degree of H.pylori density, polymorphonuclear neutrophil activity, chronic inflammation, glandular atrophy, and intestinal metaplasia classified as: 0,'absent'; 2, 'mild'; 4, 'moderate'; and 6, 'marked'. Grade of histological gastritis is evaluated with this score 0, 2, 4, and 6. Dysplasia was assessed according to the revised Vienna classification, scored as 0 (absent), 2 (mild), 4 (moderate), or 6 (marked).

    Change from baseline histological score at 6 months and 1 year

  • Change of symptoms score

    Symptoms of dyspepsia, regurgitation and defecation are assessed for severity and frequency at enrollment in every interview during the study.For each symptom, the scores are calculated by multiplying frequency by severity. All symptom scores are added to define the total symptom score.

    Change from baseline symptoms score at 6 months and 1 year

Secondary Outcomes (3)

  • Change of endoscopic atrophy

    Change from baseline endoscopic atrophy at 6 months and 1 year

  • Change of OLGA stages.

    Change from baseline at 6 months and 1 year

  • Change of OLGIM stages.

    Change from baseline endoscopic atrophy at 6 months and 1 year

Other Outcomes (9)

  • Change of serum level of pepsinogen

    Change from baseline serum level of pepsinogen at 6 months and 1 year

  • Patient-Reported Outcome Instrument developed by our research group.

    through study completion, an average of 1 month

  • Blood routine tests

    up to 24 weeks

  • +6 more other outcomes

Study Arms (2)

Chinese medicine prescription

EXPERIMENTAL

On the basis of symptomatic treatment of Talcid® and Compound Azimtamide Entieric-coated Tablets,patients in experimental group use the traditional Chinese medicine application prescription.

Drug: Talcid®Drug: Chinese medicine prescriptionDrug: Compound Azimtamide Entieric-coated Tablets

placebo

PLACEBO COMPARATOR

On the basis of symptomatic treatment of Talcid® and Compound Azimtamide Entieric-coated Tablets,patients in placebo group use the simulate granule of traditional Chinese medicine application prescription.

Drug: Talcid®Drug: PlaceboDrug: Compound Azimtamide Entieric-coated Tablets

Interventions

Talcid®DRUG

Talcid® is allowed to be taken when patients feel stomach pain, acid reflux or heartburn. Continuous taking time should not exceed one week.

Chinese medicine prescriptionplacebo
Chinese medicine prescriptionDRUG

The Chinese medicine application prescription is composed of pinellia 9g, radix scutellariae 10g, rhizoma coptidis 8g, rhizoma zingiberis 10g, radix curcumae 10g, rhizoma atractylodis 10g, roasted bighead atractylodes rhizome 10g, radix astragali 15g, spreading hedyotis herb 20g, scutellariae barbatae 20g, salvia miltiorrhiza bge 10g, the stem of noble dendrobium 10g, radix pseudostellariae 10g, fructus aurantii immaturus 10g, cortex magnoliae officinalis 10g, rhizoma curcumae 10g, ginger 3g, jujube 6g. Patients take 200ml each time, twice a day. Treatment duration are 24 weeks.

Chinese medicine prescription
PlaceboDRUG

The placebo is simulate granule of Chinese medicine application prescription. Patients take 200ml each time, twice a day. Treatment duration are 24 weeks.

placebo
Compound Azimtamide Entieric-coated TabletsDRUG

Compound Azimtamide Entieric-coated Tablets are qualified by China Food and Drug Administration. These tablets are allowed to be taken when patients feel fullness, belching or anorexia. Continuous taking time should not exceed one week.

Chinese medicine prescriptionplacebo

Eligibility Criteria

Age40 Years - 65 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Patients diagnosed with chronic atrophic gastritis.
  • Patients whose pathological diagnosis was atrophy (reduction glands) of mild/moderate grade，with or without intestinal metaplasia, with or without mild/moderate dysplasia.
  • Aged between 40 to 65 years old, male or female.
  • Patients who agree to participate in the clinical study through informed consent.
  • Local residents ensuring regular treatment and follow-up.
  • Not taking aspirin, warfarin and other anticoagulants and those without coagulation disorders.

You may not qualify if:

  • Autoimmune gastritis.
  • The combined gastric and duodenal ulcers, upper gastrointestinal bleeding.
  • Dysplasia of severe degree,or suspicious of gastric malignancy.
  • Serious comorbidities of heart, lung, liver, kidney or blood system (such as cardiac function above grade II, alanine aminotransferase (ALT) and/or aspartate aminotransferase (AST) greater than 1.5 times the upper limit of normal, creatinine (Cr) greater than the upper limit of normal and so on) or having a life-threatening illness .
  • Psychiatric disorders or a history of alcohol or drug abuse.
  • Pregnant or lactating women.
  • Allergic to the trial drug.
  • Patients judged inappropriate to participate in the trial by investigators.
  • Patients enrolled in another clinical trial last two months.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (13)

Beijing Hospital of Traditional Chinese Medicine Affiliated to Capital Medical University

Beijing, China

Location

Wangjing Hospital of China Academy of Chinese Medical Sciences

Beijing, China

Location

Xiyuan Hospital of China Academy of Chinese Medical Sciences

Beijing, China

Location

Guangdong Provincial TCM Hospital

Guangzhou, China

Location

The First Affiliated Hospital of Guangzhou University of Traditional Chinese Medicine

Guangzhou, China

Location

GanSu Provincial Hospital of Traditional Chinese Medicine

Lanzhou, China

Location

Yueyang Hospital of Integrated Traditional Chinese Medicine and Western Medicine, Affiliated Hospital of Shanghai University of Traditional Chinese Medicine

Shanghai, China

Location

Liaoning Hospital of TCM

Shenyang, China

Location

Hebei Hospital of TCM

Shijiazhuang, China

Location

Shanxi province hospital of traditional Chinese medicine

Taiyuan, China

Location

Tianjin Academy of Traditional Chinese Medicine Affiliated Hospital

Tianjin, China

Location

Tianjin Nankai Hospital

Tianjin, China

Location

Shanxi Traditional Chinese Medicine Hospital

Xi'an, China

Location

MeSH Terms

Conditions

Gastritis, Atrophic

Interventions

hydrotalcite

Condition Hierarchy (Ancestors)

GastritisGastroenteritisGastrointestinal DiseasesDigestive System DiseasesStomach Diseases

Study Officials

  • Wei Wei, Ph.D

    Wangjing Hospital of China Academy of Chinese Medical Sciences

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
QUADRUPLE
Who Masked
PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

October 28, 2016

First Posted

November 4, 2016

Study Start

March 12, 2018

Primary Completion

May 1, 2021

Study Completion

November 30, 2021

Last Updated

March 11, 2022

Record last verified: 2022-02

Locations

CN(13)