The Study of Chinese Medicine for the Treatment of Chronic Atrophic Gastritis
- Conditions
- Chronic Atrophic Gastritis
- Interventions
- Drug: Chinese medicine prescriptionDrug: PlaceboDrug: Compound Azimtamide Entieric-coated Tablets
- Registration Number
- NCT02955134
- Lead Sponsor
- Wangjing Hospital, China Academy of Chinese Medical Sciences
- 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.
- 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.
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 468
Not provided
Not provided
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description Chinese medicine prescription 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. Chinese medicine prescription Compound Azimtamide Entieric-coated Tablets 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. placebo Talcid® 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. placebo 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. placebo Compound Azimtamide Entieric-coated Tablets 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. Chinese medicine prescription Talcid® 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.
- Primary Outcome Measures
Name Time Method Change of histological score Change from baseline histological score at 6 months and 1 year 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 of symptoms score Change from baseline symptoms score at 6 months and 1 year 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.
- Secondary Outcome Measures
Name Time Method Change of endoscopic atrophy Change from baseline endoscopic atrophy at 6 months and 1 year 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.
Change of OLGA stages. Change from baseline at 6 months and 1 year 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.
Change of OLGIM stages. Change from baseline endoscopic atrophy at 6 months and 1 year 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.
Trial Locations
- Locations (13)
Liaoning Hospital of TCM
🇨🇳Shenyang, 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
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
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