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

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

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.

Study Overview

• Status: Completed
• Conditions: Gastritis
• Intervention / Treatment: Other: Houtou Jianweiling tablet; Drug: Omeprazole Tablet

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.

• Study Type: Interventional
• Enrollment (Actual): 240
• Phase: Phase 2

Contacts and Locations

Study Locations

• Pakistan
  • Karachi, Pakistan, 75270
    • Center for Bioequivalence Studies and Clinical Research (CBSCR), ICCBS, university of Karachi

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 65 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No

Description

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.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Double

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Test group (Houtou Jianeweiling 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.	Other: 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.; Other Names: Traditional Chinese Medicine (TCM)
Active Comparator: Control group (Omeprazole enteric-coated 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.	Drug: 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.; Other Names: Active comparator

What is the study measuring?

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

Other Outcome Measures

Outcome Measure	Measure Description	Time Frame
Physical examination	blood pressure	During the 4 weeks treatment period
Body Temperature	body temperature	During the 4 weeks treatment period
vital signs	pulse rate, respiration rate	During the 4 weeks treatment period
Electrocardiogram	ECG QT Interval evaluation	within 10 days before enrollment and within 5 days after the end of treatment
Renal function	BUN, Cr	within 10 days before enrollment and within 5 days after the end of treatment
Stool tests	Stool occult blood test	within 10 days before enrollment and within 5 days after the end of treatment

Collaborators and Investigators

• Sponsor: University of Karachi
• Collaborators: Hunan Xinhui Pharmacy Limited Company

Study record dates

Study Major Dates

• Study Start (Actual): November 8, 2022
• Primary Completion (Actual): February 2, 2023
• Study Completion (Actual): February 2, 2023

Study Registration Dates

• First Submitted: November 28, 2020
• First Submitted That Met QC Criteria: December 11, 2020
• First Posted (Actual): December 17, 2020

Study Record Updates

• Last Update Posted (Actual): April 18, 2023
• Last Update Submitted That Met QC Criteria: April 13, 2023
• Last Verified: April 1, 2023

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Digestive System Diseases; Gastrointestinal Diseases; Stomach Diseases; Gastroenteritis; Gastritis; Molecular Mechanisms of Pharmacological Action; Enzyme Inhibitors; Gastrointestinal Agents; Anti-Ulcer Agents; Proton Pump Inhibitors; Omeprazole
• Other Study ID Numbers: CRO-002-TCM-HTJWT-2019

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No