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Chronic Atrophic GastritisNCT02955134

The Study of Chinese Medicine for the Treatment of Chronic Atrophic Gastritis

A study testing Talcid®, Chinese medicine prescription and Compound Azimtamide Entieric-coated Tablets in people with Chronic Atrophic Gastritis, run by Wangjing Hospital, China Academy of Chinese Medical Sciences at 13 sites in China.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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Trial 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. Read more about this study

Who is it for?
Ages 40 to 65 years
Conditions the study is for
Chronic Atrophic Gastritis
What is being tested?
Talcid®, Chinese medicine prescription and Compound Azimtamide Entieric-coated Tablets
Type of treatment
Pill or oral medicine
Could I receive a placebo?
Yes, some participants may receive a placebo
How many people
468 participants
Where
13 sitesChina
Study dates
12 Mar 2018to 30 Nov 2021
Phase
Interventional
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 40 to 65 years
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • 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.

Who cannot join

  • 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.
Show all 9Show fewer
  • Allergic to the trial drug.
  • Patients judged inappropriate to participate in the trial by investigators.
  • Patients enrolled in another clinical trial last two months.

Trial locations and contacts

13 sites in 1 country.

13 sites in 1 country

China13 sites

  • Beijing Hospital of Traditional Chinese Medicine Affiliated to Capital Medical University

    Beijing

  • Wangjing Hospital of China Academy of Chinese Medical Sciences

    Beijing

  • Xiyuan Hospital of China Academy of Chinese Medical Sciences

    Beijing

  • Guangdong Provincial TCM Hospital

    Guangzhou

  • The First Affiliated Hospital of Guangzhou University of Traditional Chinese Medicine

    Guangzhou

  • GanSu Provincial Hospital of Traditional Chinese Medicine

    Lanzhou

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

    Shanghai

  • Liaoning Hospital of TCM

    Shenyang

  • Hebei Hospital of TCM

    Shijiazhuang

  • Shanxi province hospital of traditional Chinese medicine

    Taiyuan

  • Tianjin Academy of Traditional Chinese Medicine Affiliated Hospital

    Tianjin

  • Tianjin Nankai Hospital

    Tianjin

  • Shanxi Traditional Chinese Medicine Hospital

    Xi'an

Other trials in China

About this study

Official title: Follow-up Study of Chinese Medicine for the Treatment of Chronic Atrophic Gastritis Based on Histological Evaluation

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.

Read the detailed description

A prospective, double-blind, randomized, placebo-controlled, multi-center trial is carried out in this study.The sample size is 468 patients ( 312 in treatment group, 156 in control group). The investigators will screen the patients for inclusion according to the inclusion and exclusion criteria. All patients detect of H.pylori, undergo upper digestive endoscopy and biopsies for histological investigation. Patients infected of H.pylori must receive H.pylori eradication therapy under the guidance of Kyoto global consensus report on H.pylori gastritis. Then they are assigned to treatment group or control group with an allocation ratio of 2:1. Patients intreatment group take the traditional Chinese medicine prescription, while the control group take simulate granule of the prescription. Both two groups are under symptomatic treatment. Treatment duration lasts 24 weeks. Investigators also follow up another 24 weeks. Histological changes are used as the primary outcome index. Endoscopy findings, symptoms are assessed. Serum level of pepsinogen and patient-reported outcome instrument are also administered during the study. All biopsy specimens are collected to build the biological specimen bank. Central blinded histological assessment (Histological diagnosis is determined independently by three experienced pathologists who are blinded to the information of the patients.) are used to insure the accuracy and consistency. Tele-medicine and information management system is established to help achieve follow-up interviews.

Random numbers are generated by SAS 9.4 software. The subjects, caregivers, investigators and outcomes assessors in this study are all blinded.

Being tested
Talcid®, Chinese medicine prescription, Placebo, Compound Azimtamide Entieric-coated Tablets
Keywords
central blinded histological assessment, traditional Chinese medicine intervention, biological specimen banks
Medical subject headings
Gastritis, Atrophic

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • 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 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.

  • PlaceboDrug

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

  • 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.

Study groups in NCT02955134
Study groupRoleWhat they receive
Chinese medicine prescriptionExperimentalOn the basis of symptomatic treatment of Talcid® and Compound Azimtamide Entieric-coated Tablets,patients in experimental group use the traditional Chinese medicine application prescription.
Receives: Drug: Talcid®; Drug: Chinese medicine prescription; Drug: Compound Azimtamide Entieric-coated Tablets
placeboPlacebo comparatorOn 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.
Receives: Drug: Talcid®; Drug: Placebo; Drug: Compound Azimtamide Entieric-coated Tablets

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. 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).

    Measured: Change from baseline histological score at 6 months and 1 year

  2. 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.

    Measured: Change from baseline symptoms score at 6 months and 1 year

Secondary outcomes (3)

  1. Change of endoscopic atrophy

    Endoscopic atrophy are defined using an endoscopicatrophic border scale previously reported by Kimura and Takemoto. This scale correlates with histological results and includes the following classifications: 1 close-type, when the atrophic border remains on the lesser curvature of the stomach; 2 open-type, when the atrophic border extends along the anterior and posterior walls of the stomach and is not associated with the lesser curvature of the stomach. Close-type and open-type atrophy are further classified as none (C0), mild (C1, 2),moderate (C3, O1), and severe (O2, 3) atrophy. In this study, atrophy grade are also scored as C0: 0, C1: 1, C2: 2, C3:3, O1: 4, O2: 5, and O3: 6 respectively, with 0 representing an absence of atrophy and 6 indicating severe atrophy.

    Measured: Change from baseline endoscopic atrophy at 6 months and 1 year

  2. Change of OLGA stages.

    Three expert GI pathologists, who are blinded for the endoscopic findings, independently assessed all biopsy specimens of the surveillance endoscopy. The type and grade of the different stages of changes are classified according to the updated Sydney system and scored as 0 (absent), 1 (mild), 2(moderate), or 3 (marked) by using the Sydney system visual analog scale. On the basis of the standardized sites, the gastritis stages areassess according to the OLGA.

    Measured: Change from baseline at 6 months and 1 year

  3. Change of OLGIM stages.

    Three expert GI pathologists, who are blinded for the endoscopic findings, independently assessed all biopsy specimens of the surveillance endoscopy. The type and grade of the different stages of changes are classified according to the updated Sydney system and scored as 0 (absent), 1 (mild), 2(moderate), or 3 (marked) by using the Sydney system visual analog scale. On the basis of the standardized sites, the gastritis stages areassess according to the OLGA.

    Measured: Change from baseline endoscopic atrophy at 6 months and 1 year

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted4 Nov 2016 (estimated)
  2. Study start12 Mar 2018
  3. Primary completion1 May 2021
  4. Study completion30 Nov 2021

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase N/A
Primary purpose
Treatment
Allocation
Randomised
Intervention model
Parallel groups
Masking
Quadruple blind
Who is masked
Participant, Care provider, Investigator, Outcomes assessor
Enrolment
468 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT02955134
Sponsor's protocol ID
201507001-09
Status last verified
Feb 2022
First submitted
28 Oct 2016
Last updated
11 Mar 2022
Results posted
No
Data monitoring committee
Yes
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
Undecided

Publications

  • Yang Y, Qin Z, Du S, Fang S, Ma Y, Liu Z, Zhou W, Liu X, Tay ACY, Tang Y, Wang C, Su J, Liu F, Shu J, Tian X, Yang Q, Liu H, Liu L, Yu T, Li Z, Zhang Z, Li Y, Wang X, Xiong G, Liu J, Duan DD, Zhang P, Wei W. Efficacy of Chinese medicine WW-1 in managing gastric atrophy and intestinal metaplasia in patients with chronic atrophic gastritis: A multicenter, randomized, double-blind, placebo-controlled trial. Pharmacol Res. 2026 May;227:108176. doi: 10.1016/j.phrs.2026.108176. Epub 2026 Apr 1.

    PubMed 41932668

Questions about this trial

What is this clinical trial studying?

A study testing Talcid®, Chinese medicine prescription and Compound Azimtamide Entieric-coated Tablets in people with Chronic Atrophic Gastritis, run by Wangjing Hospital, China Academy of Chinese Medical Sciences at 13 sites in China.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 6 inclusion and 9 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 11 Mar 2022. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 13 sites in China. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Change of histological score (time frame: Change from baseline histological score at 6 months and 1 year). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT02955134, which also lists 1 linked publication.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 11 Mar 2022.

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