The Study of Chinese Medicine for the Treatment of Chronic Atrophic Gastritis
NCT ID: NCT02955134
Last Updated: 2022-03-11
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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COMPLETED
NA
468 participants
INTERVENTIONAL
2018-03-12
2021-11-30
Brief Summary
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Detailed Description
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Random numbers are generated by SAS 9.4 software. The subjects, caregivers, investigators and outcomes assessors in this study are all blinded.
Conditions
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
QUADRUPLE
Study Groups
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Chinese medicine prescription
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.
Talcid®
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 prescription
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.
Compound Azimtamide Entieric-coated Tablets
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.
placebo
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.
Talcid®
Talcid® is allowed to be taken when patients feel stomach pain, acid reflux or heartburn. Continuous taking time should not exceed one week.
Placebo
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 Tablets
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.
Interventions
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Talcid®
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 prescription
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.
Placebo
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 Tablets
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.
Eligibility Criteria
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Inclusion Criteria
2. Patients whose pathological diagnosis was atrophy (reduction glands) of mild/moderate grade，with or without intestinal metaplasia, with or without mild/moderate dysplasia.
3. Aged between 40 to 65 years old, male or female.
4. Patients who agree to participate in the clinical study through informed consent.
5. Local residents ensuring regular treatment and follow-up.
6. Not taking aspirin, warfarin and other anticoagulants and those without coagulation disorders.
Exclusion Criteria
2. The combined gastric and duodenal ulcers, upper gastrointestinal bleeding.
3. Dysplasia of severe degree,or suspicious of gastric malignancy.
4. 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 .
5. Psychiatric disorders or a history of alcohol or drug abuse.
6. Pregnant or lactating women.
7. Allergic to the trial drug.
8. Patients judged inappropriate to participate in the trial by investigators.
9. Patients enrolled in another clinical trial last two months.
40 Years
65 Years
ALL
No
Sponsors
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Beijing University of Chinese Medicine
OTHER
Xiyuan Hospital of China Academy of Chinese Medical Sciences
OTHER
Shaanxi Hospital of Traditional Chinese Medicine
OTHER
Gansu Provincial Hospital
OTHER
Tianjin Nankai Hospital
OTHER
The First Affiliated Hospital, Guangzhou University of Traditional Chinese Medicine
OTHER
Guangdong Provincial Hospital of Traditional Chinese Medicine
OTHER
Hebei Hospital of Traditional Chinese Medicine
UNKNOWN
Tianjin Academy of Traditional Chinese Medicine Affiliated Hospital
UNKNOWN
Shanxi Province hospital Research Institute of Traditional Chinese Medicine
UNKNOWN
Affiliated Hospital of Liaoning University of Traditional Chinese Medicine
OTHER
Shanghai University of Traditional Chinese Medicine
OTHER
China-Japan Friendship Hospital
OTHER
Wangjing Hospital, China Academy of Chinese Medical Sciences
OTHER
Responsible Party
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Principal Investigators
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Wei Wei, Ph.D
Role: PRINCIPAL_INVESTIGATOR
Wangjing Hospital of China Academy of Chinese Medical Sciences
Locations
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Beijing Hospital of Traditional Chinese Medicine Affiliated to Capital Medical University
Beijing, , China
Wangjing Hospital of China Academy of Chinese Medical Sciences
Beijing, , China
Xiyuan Hospital of China Academy of Chinese Medical Sciences
Beijing, , China
Guangdong Provincial TCM Hospital
Guangzhou, , China
The First Affiliated Hospital of Guangzhou University of Traditional Chinese Medicine
Guangzhou, , China
GanSu Provincial Hospital of Traditional Chinese Medicine
Lanzhou, , China
Yueyang Hospital of Integrated Traditional Chinese Medicine and Western Medicine, Affiliated Hospital of Shanghai University of Traditional Chinese Medicine
Shanghai, , China
Liaoning Hospital of TCM
Shenyang, , China
Hebei Hospital of TCM
Shijiazhuang, , China
Shanxi province hospital of traditional Chinese medicine
Taiyuan, , China
Tianjin Academy of Traditional Chinese Medicine Affiliated Hospital
Tianjin, , China
Tianjin Nankai Hospital
Tianjin, , China
Shanxi Traditional Chinese Medicine Hospital
Xi'an, , China
Countries
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Other Identifiers
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201507001-09
Identifier Type: -
Identifier Source: org_study_id
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