Gastritis
Conditions
Brief summary
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
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.
Interventions
OTHERHoutou Jianweiling tablet
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.
DRUGOmeprazole Tablet
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.
Sponsors
Hunan Xinhui Pharmacy Limited Company
University of Karachi
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
DOUBLE (Subject, Investigator)
Masking description
Double Blind
Intervention model description
Randomized, Double-Blind, Placebo-Controlled, Non-inferiority Clinical Trial
Eligibility
Sex/Gender
ALL
Age
18 Years to 65 Years
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| The improvement rate of main Clinical symptoms | During the four-week trial period | 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. |
| Physicians Global Assessment to measure quality of life (PGA) | During the four-week trial period | 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. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Respiration rate measurement | During the 4 weeks treatment period | The Respiration rate of patients will be measured at different times |
| Blood Pressure measurement | During the 4 weeks treatment period | Systolic and Diastolic blood pressure of patients will be measured at different times |
| Laboratory examinations | before enrollment and within 5 days after treatment | 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) |
| Electrocardiogram | before enrollment and within 5 days after treatment | ECG QT Interval evaluation |
| Stool test for H. Pylori | within 5 days after treatment | Stool antigen test for H. Pylori detection |
| Body Temperature measurement | During the 4 weeks treatment period | The Body Temperature of patients will be measured at different times |
| Pulse rate measurement | During the 4 weeks treatment period | The Pulse rate of patients will be measured at different times |
Countries
Pakistan
Outcome results
None listed