Efficacy and Safety of Houtou Jianweiling Tablet in the Treatment of Chronic Non-Atrophic Gastritis
- Conditions
- Gastritis
- Interventions
- Other: Houtou Jianweiling tablet
- Registration Number
- NCT04672018
- Lead Sponsor
- University of Karachi
- 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.
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 240
- (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.
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(1) Subjects with history of gastric surgery.
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(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.
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(3) Patients with atrophy and/or intestinal metaplasia through pathological examination showed;.
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(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;
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(5) Patients who have used Chinese and Western medicine to treat chronic non-atrophic gastritis in the last two weeks;
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(6) Subjects with psychiatric disorders or a history of alcohol/drug abuse;
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(7) Pregnant women, woman who are preparing for pregnancy, lactating women;
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(8) Patients who are allergic constitution or allergic to known ingredients of test drugs;
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(9) Those who have participated in or are participating in other drug clinical trials in the past 3 months;
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(10) The syndrome differentiation is not clear or there are too many and complicated syndromes for the subjects;
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(11) Subjects that researchers do not consider appropriate to participate in clinical trials.
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(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.
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description Test group (Houtou Jianeweiling tablet ) Houtou 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. Control group (Omeprazole enteric-coated tablet) Omeprazole 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.
- Primary Outcome Measures
Name Time Method 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 Outcome Measures
Name Time Method 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)
Blood Pressure measurement During the 4 weeks treatment period Systolic and Diastolic blood pressure 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
Respiration rate measurement During the 4 weeks treatment period The Respiration rate of patients will be measured at different times
Body Temperature measurement During the 4 weeks treatment period The Body Temperature of patients will be measured at different times
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
Trial Locations
- Locations (1)
Center for Bioequivalence Studies and Clinical Research (CBSCR), ICCBS, university of Karachi
🇵🇰Karachi, Pakistan