Efficacy and Safety of Houtou Jianweiling Tablet in the Treatment of Chronic Non-Atrophic Gastritis

Study Overview
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Brief Summary
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To study the efficacy & safety of Houtou Jianweiling tablet through the non-inferiority clinical trial of Houtou Jianweiling tablet with Omeprazole Enteric-coated tablet in patients with chronic non-atrophic gastritis.

Detailed Description
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This is a Randomized, Double-Blind, Placebo-Controlled, Non-inferiority Clinical Trial on the Efficacy and Safety of Houtou Jianweiling Tablet in the Treatment of Chronic Non-Atrophic Gastritis.

Official Title
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Randomized, Double-Blind, Placebo-Controlled, Non-inferiority Clinical Trial on the Efficacy and Safety of Houtou Jianweiling Tablet in the Treatment of Chronic Non-Atrophic Gastritis

Conditions
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Gastritis

Intervention / Treatment
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* Other: Houtou Jianweiling tablet
* Drug: Omeprazole Tablet


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: (1) Comply with the diagnostic criteria for chronic non-atrophic gastritis. (2) Age between 18 to 65 years. (3) Voluntarily participate the clinical trials and sign informed consent. Exclusion Criteria: (1) Subjects with history of gastric surgery. (2) Patients with complicated and special types of gastritis, peptic ulcer, hemorrhage, cholecystitis, cholelithiasis, dysplasia of gastric mucosa or pathological diagnosis of suspected malignant change. (3) Patients with atrophy and/or intestinal metaplasia through pathological examination showed;. (4) Severe primary diseases associated with cardiovascular, cerebrovascular, lung, liver, kidney and hematopoietic system (above grade II of cardiac function; Cr value above the upper limit of normal value), or serious diseases affecting their survival, such as cancer or AIDS; (5) Patients who have used Chinese and Western medicine to treat chronic non-atrophic gastritis in the last two weeks; (6) Subjects with psychiatric disorders or a history of alcohol/drug abuse; (7) Pregnant women, woman who are preparing for pregnancy, lactating women; (8) Patients who are allergic constitution or allergic to known ingredients of test drugs; (9) Those who have participated in or are participating in other drug clinical trials in the past 3 months; (10) The syndrome differentiation is not clear or there are too many and complicated syndromes for the subjects; (11) Subjects that researchers do not consider appropriate to participate in clinical trials. (12) Patients with poor compliance are not allowed to participate in this trial. Those who meet one or more of the above exclusion criteria cannot be included in the clinical trial.

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 65 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Interventional Model Description: Randomized, Double-Blind, Placebo-Controlled, Non-inferiority Clinical Trial
Masking: Double


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Test group (Houtou Jianeweiling tablet )<br>Houtou Jianweiling tablet (0.38 g), 4 tablets taken orally at a time, 3 times a day and Omeprazole Enteric-coated placebo tablet, taken 1 tablet orally once a day before breakfast. | Other: Houtou Jianweiling tablet<br>* Houtou Jianweiling tablet (0.38 g), 4 tablets taken orally at a time, 3 times a day and Omeprazole Enteric-coated placebo tablet, taken 1 tablet orally once a day before breakfast.<br>* Other names: Traditional Chinese Medicine (TCM);|
| Active Comparator: Control group (Omeprazole enteric-coated tablet)<br>Omeprazole Enteric-coated tablet (20 mg), 1 tablet taken orally once a day before breakfast and Houtou Jianweiling placebo tablets, taken orally, 4 tablets at a time, 3 times a day. | Drug: Omeprazole Tablet<br>* Omeprazole Enteric-coated tablet (20 mg), 1 tablet taken orally once a day before breakfast and Houtou Jianweiling placebo tablets, taken orally, 4 tablets at a time, 3 times a day.<br>* Other names: Active comparator;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| The improvement rate of main Clinical symptoms | Gastric pain assessment（VAS score): Applying the Visual Analogue Scale (VAS) i.e. 0-10 Numeric Pain Intensity Scale on a 10 cm line segment, 0 is painless, 10 is extremely painful, patients will marked in the corresponding position according to the degree of pain, and the amount of the researcher give a specific score. The grading criteria of gastralgia with VAS score will be, normal: 0 cm; mild: 1-3 cm; moderate: 4-6 cm; severe: 7-10 cm. | During the four-week trial period | 
| Physicians Global Assessment to measure quality of life (PGA) | Therapeutic efficacy evaluation by primary symptoms i.e. Gastric Distension on 0-6 points scoring system e.g. 0 point: None before treatment or disappeared after treatment 2 points: Slight gastric distension, from time to time, does not affect work and rest. 4 points: Gastric distension can be tolerable, attacks frequently, affecting work and rest. 6 points: The gastric distension is intolerable and persist for a long time. Often needs pain killer to relief pain. | During the four-week trial period | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Laboratory examinations | Routine blood tests for liver function (alanine aminotransferase ALT, aspartate aminotransferase AST, gama γ-glutamyltransferase GGT, alkaline phosphatase ALP, total bilirubin T.BIL), Renal Function tests (BUN, Cr) | before enrollment and within 5 days after treatment | 
| Pulse rate measurement | The Pulse rate of patients will be measured at different times | During the 4 weeks treatment period | 
| Respiration rate measurement | The Respiration rate of patients will be measured at different times | During the 4 weeks treatment period | 
| Blood Pressure measurement | Systolic and Diastolic blood pressure of patients will be measured at different times | During the 4 weeks treatment period | 
| Body Temperature measurement | The Body Temperature of patients will be measured at different times | During the 4 weeks treatment period | 
| Electrocardiogram | ECG QT Interval evaluation | before enrollment and within 5 days after treatment | 
| Stool test for H. Pylori | Stool antigen test for H. Pylori detection | within 5 days after treatment |