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

Primary Purpose

Gastritis

Status
Completed
Phase
Phase 2
Locations
Pakistan
Study Type
Interventional
Intervention
Houtou Jianweiling tablet
Omeprazole Tablet
Sponsored by
University of Karachi
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Gastritis

Eligibility Criteria

18 Years - 65 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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; ALT&AST are 1.5 times higher than the normal value; Cr value above the upper limit of normal value), or serious diseases affecting their survival, such as cancer or AIDS;
  • (5) Positive stool occult blood patients;
  • (6) Patients who have used Chinese and Western medicine to treat chronic non-atrophic gastritis in the last two weeks;
  • (7) Subjects with psychiatric disorders or a history of alcohol/drug abuse;
  • (8) Pregnant women, woman who are preparing for pregnancy, lactating women;
  • (9) Patients who are allergic constitution or allergic to known ingredients of test drugs;
  • (10) Those who have participated in or are participating in other drug clinical trials in the past 3 months;
  • (11) The syndrome differentiation is not clear or there are too many and complicated syndromes for the subjects;
  • (12) Subjects that researchers do not consider appropriate to participate in clinical trials.

  • (13) 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.

Sites / Locations

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

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Active Comparator

Arm Label

Test group (Houtou Jianeweiling tablet )

Control group (Omeprazole enteric-coated tablet)

Arm Description

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.

Outcomes

Primary Outcome Measures

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.
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.

Secondary Outcome Measures

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)
Pulse rate measurement
The Pulse rate of patients will be measured at different times
Respiration rate measurement
The Respiration rate of patients will be measured at different times
Blood Pressure measurement
Systolic and Diastolic blood pressure of patients will be measured at different times
Body Temperature measurement
The Body Temperature of patients will be measured at different times
Electrocardiogram
ECG QT Interval evaluation
Stool test for H. Pylori
Stool antigen test for H. Pylori detection

Full Information

First Posted
November 28, 2020
Last Updated
April 13, 2023
Sponsor
University of Karachi
Collaborators
Hunan Xinhui Pharmacy Limited Company
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1. Study Identification

Unique Protocol Identification Number
NCT04672018
Brief Title
Efficacy and Safety of Houtou Jianweiling Tablet in the Treatment of Chronic Non-Atrophic Gastritis
Acronym
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
Study Type
Interventional

2. Study Status

Record Verification Date
April 2023
Overall Recruitment Status
Completed
Study Start Date
November 8, 2022 (Actual)
Primary Completion Date
February 2, 2023 (Actual)
Study Completion Date
February 2, 2023 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
University of Karachi
Collaborators
Hunan Xinhui Pharmacy Limited Company

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Gastritis

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 2
Interventional Study Model
Parallel Assignment
Model Description
Randomized, Double-Blind, Placebo-Controlled, Non-inferiority Clinical Trial
Masking
ParticipantInvestigator
Masking Description
Double Blind
Allocation
Randomized
Enrollment
240 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Test group (Houtou Jianeweiling tablet )
Arm Type
Experimental
Arm Description
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.
Arm Title
Control group (Omeprazole enteric-coated tablet)
Arm Type
Active Comparator
Arm Description
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.
Intervention Type
Other
Intervention Name(s)
Houtou Jianweiling tablet
Other Intervention Name(s)
Traditional Chinese Medicine (TCM)
Intervention Description
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.
Intervention Type
Drug
Intervention Name(s)
Omeprazole Tablet
Other Intervention Name(s)
Active comparator
Intervention Description
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 Measure Information:
Title
The improvement rate of main Clinical symptoms
Description
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
Title
Physicians Global Assessment to measure quality of life (PGA)
Description
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
Secondary Outcome Measure Information:
Title
Laboratory examinations
Description
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
Title
Pulse rate measurement
Description
The Pulse rate of patients will be measured at different times
Time Frame
During the 4 weeks treatment period
Title
Respiration rate measurement
Description
The Respiration rate of patients will be measured at different times
Time Frame
During the 4 weeks treatment period
Title
Blood Pressure measurement
Description
Systolic and Diastolic blood pressure of patients will be measured at different times
Time Frame
During the 4 weeks treatment period
Title
Body Temperature measurement
Description
The Body Temperature of patients will be measured at different times
Time Frame
During the 4 weeks treatment period
Title
Electrocardiogram
Description
ECG QT Interval evaluation
Time Frame
before enrollment and within 5 days after treatment
Title
Stool test for H. Pylori
Description
Stool antigen test for H. Pylori detection
Time Frame
within 5 days after treatment

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
65 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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.
Facility Information:
Facility Name
Center for Bioequivalence Studies and Clinical Research (CBSCR), ICCBS, university of Karachi
City
Karachi
ZIP/Postal Code
75270
Country
Pakistan

12. IPD Sharing Statement

Plan to Share IPD
No

Learn more about this trial

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

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