Skip to main content
OpenTrials
Completed

NCT Number: NCT04672018

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.

Completed

Looking for future studies?

Notify Me

Key information

Conditions

Gastritis Digestive System Diseases Gastroenteritis Gastrointestinal Diseases Stomach Diseases

Age range

18 year–65 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 2

Primary location

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

Karachi, 75270, Pakistan

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

Houtou Jianweiling tablet

Other

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)

Omeprazole Tablet

Drug

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

Primary outcomes

  1. The improvement rate of main Clinical symptoms

    Time frame: 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.

  2. Physicians Global Assessment to measure quality of life (PGA)

    Time frame: 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 outcomes

  1. Laboratory examinations

    Time frame: 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)

  2. Pulse rate measurement

    Time frame: During the 4 weeks treatment period

    The Pulse rate of patients will be measured at different times

  3. Respiration rate measurement

    Time frame: During the 4 weeks treatment period

    The Respiration rate of patients will be measured at different times

  4. Blood Pressure measurement

    Time frame: During the 4 weeks treatment period

    Systolic and Diastolic blood pressure of patients will be measured at different times

  5. Body Temperature measurement

    Time frame: During the 4 weeks treatment period

    The Body Temperature of patients will be measured at different times

  6. Electrocardiogram

    Time frame: before enrollment and within 5 days after treatment

    ECG QT Interval evaluation

  7. Stool test for H. Pylori

    Time frame: within 5 days after treatment

    Stool antigen test for H. Pylori detection

Sponsors and collaborators

Lead sponsor

University of Karachi

Other

Collaborators

  • Hunan Xinhui Pharmacy Limited Company

Registry information

Official study 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

Acronym: CT

Important dates

Study start
2022
Primary completion
2023
Study completion
2023
First posted
Dec 17, 2020
Registry last updated
Apr 18, 2023

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Related clinical trials

Published trials that share one or more normalized conditions with this study.