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

Gastritis Clinical Trial

— CT  

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT04672018
• Other study ID #: CRO-002-TCM-HTJWT-2019
• Status: Completed
• Phase: Phase 2
• Start date: November 8, 2022
• Est. completion date: February 2, 2023

Study information

• Verified date: April 2023
• Source: University of Karachi
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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 information / eligibility

• Status: Completed
• Enrollment: 240
• Est. completion date: February 2, 2023
• Est. primary completion date: February 2, 2023
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 65 Years

Eligibility

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.

Related Conditions & MeSH terms

• Gastritis

Intervention

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.

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.

Locations

Country	Name	City	State
Pakistan	Center for Bioequivalence Studies and Clinical Research (CBSCR), ICCBS, university of Karachi	Karachi

Sponsors (2)

Lead Sponsor	Collaborator
University of Karachi	Hunan Xinhui Pharmacy Limited Company

Country where clinical trial is conducted

Pakistan, 

Outcome

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