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.
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.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
DOUBLE
Enrollment
240
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.
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.
Center for Bioequivalence Studies and Clinical Research (CBSCR), ICCBS, university of Karachi
Karachi, Pakistan
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.
Time frame: 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.
Time frame: During the four-week trial period
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)
Time frame: before enrollment and within 5 days after treatment
Pulse rate measurement
The Pulse rate of patients will be measured at different times
Time frame: During the 4 weeks treatment period
Respiration rate measurement
The Respiration rate of patients will be measured at different times
Time frame: During the 4 weeks treatment period
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Blood Pressure measurement
Systolic and Diastolic blood pressure of patients will be measured at different times
Time frame: During the 4 weeks treatment period
Body Temperature measurement
The Body Temperature of patients will be measured at different times
Time frame: During the 4 weeks treatment period
Electrocardiogram
ECG QT Interval evaluation
Time frame: before enrollment and within 5 days after treatment
Stool test for H. Pylori
Stool antigen test for H. Pylori detection
Time frame: within 5 days after treatment