self-funding
Conditions
Interventions
experimental group:Xinwei Recipe + Quadruple Therapy for Hp Eradication
control group:Quadruple therapy for Helicobacter pylori eradication
health group:no
Sponsors
Shenzhen Hospital of Guangzhou University of Chinese Medicine (Futian)
Eligibility
Sex/Gender
All
Age
18 Years to 70 Years
Inclusion criteria
Inclusion criteria: The inclusion criteria of the experimental group and the control group: those who met the diagnostic criteria of Western medicine and TCM syndrome diagnosis criteria; Aged between 18 and 70; Hp initial eradication therapy; Gastroscopy for gastrointestinal symptoms (including upper abdominal pain upper abdominal distension early satiety belching nausea vomiting and other upper abdominal discomfort); Voluntarily sign relevant informed consent and participate in this clinical project; Patients who have not used proton pump inhibitors (PPI) H2 receptor antagonists (H2RA) antibiotics gastric mucosal protective agents microecological preparations and Chinese medicines with anti-inflammatory effects within 1 month; No patients with serious organ diseases such as cardiovascular liver kidney and hematopoietic system blood diseases mental diseases no B virus patients patients carrying EB virus. Inclusion criteria for the healthy group: healthy subjects aged 18-70 years old regardless of gender willing to participate in gastroenteroscopy; The time limit of gastroscopy and pathology report should be within six months before inclusion in the study. Relevant serological examinations were performed within 1 week or within 1 week of inclusion in the study and serological indicators were re-examined within 1 week after 2 courses of treatment; Except chronic superficial gastritis there were no other organic lesions such as ulcers erosion bleeding atrophy etc. No patients with serious organ diseases such as cardiovascular liver kidney and hematopoietic system or related diseases affecting stomach microecology blood diseases mental diseases no patients with Type B virus patients with Epstein-Barr virus.
Exclusion criteria
Exclusion criteria: Exclusion criteria for the experimental group and control group: those who did not meet the diagnostic criteria or those who were 70 years old; Patients who have used H2RA PPI antibiotics gastric mucosal protective agents microecological preparations and Chinese medicines with anti-inflammatory effects within 1 month; Patients with pain and discomfort in the stomach duct caused by myocardial injury (three abnormalities of myocardial infarction) or other systemic diseases (such as bronchial asthma thyroid diseases diabetes chronic renal insufficiency mental and nervous system diseases blood diseases etc.) or other serious underlying diseases (such as heart failure liver and kidney failure etc.); Women who are breastfeeding pregnant or planning to become pregnant; Have serious adverse habits such as smoking alcohol or drug abuse or are otherwise unfit to be an observer in drug trials; Patients who need to take non-steroidal anti-inflammatory drugs antidepressants antihistamines and other drugs for a long time have participated in or are participating in other drug trials within the past 3 months and can not rule out other drug interference; People who have a history of allergy or suspected allergy to therapeutic drugs allergic constitution; Patients with other organic diseases of the digestive system (such as chronic pancreatitis cirrhosis ulcer disease gastric cancer etc.) and a history of gastrectomy; Spouses and family members infected with Hp and no treatment intention during the test eradication period; Disease with other complications that may interfere with observation of efficacy or contraindications to the investigational drug; B virus patients patients with Epstein-Barr virus. Exclusion criteria in the healthy group: patients who met the diagnostic criteria for Hp infection or had previously been infected with Hp; Patients with functional digestive system diseases such as functional dyspepsia; Patients with organic diseases of digestive system such as peptic ulcer gastrointestinal bleeding suspected upper gastrointestinal tumor and history of upper gastrointestinal surgery; Suffering from serious diseases of the liver kidney heart brain hematopoietic system and other primary diseases or serious diseases affecting their survival such as malignant tumors AIDS etc.; And those with mental illness and significant cognitive impairment; He has hepatitis B Epstein-Barr virus infection and abnormal glucose and lipid metabolism
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Symptom score;13C-urea breath test;Gastric juice; | — |
Secondary
| Measure | Time frame |
|---|---|
| Pathology;Serum;Helicobacter pylori Antibody Typing Test;gastroscopy; | — |
Countries
China
Contacts
Public ContactChen Xiaoting
Shenzhen Hospital of Guangzhou University of Chinese Medicine (Futian)
Outcome results
None listed