NCT04672018

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
240

participants targeted

Target at P75+ for phase_2

Timeline
Completed

Started Nov 2022

Shorter than P25 for phase_2

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

November 28, 2020

Completed
19 days until next milestone

First Posted

Study publicly available on registry

December 17, 2020

Completed
1.9 years until next milestone

Study Start

First participant enrolled

November 8, 2022

Completed
3 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

February 2, 2023

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

February 2, 2023

Completed
Last Updated

April 18, 2023

Status Verified

April 1, 2023

Enrollment Period

3 months

First QC Date

November 28, 2020

Last Update Submit

April 13, 2023

Conditions

Gastritis

Outcome Measures

Primary Outcomes (2)

  • 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 Outcomes (7)

  • Laboratory examinations

    before enrollment and within 5 days after treatment

  • Pulse rate measurement

    During the 4 weeks treatment period

  • Respiration rate measurement

    During the 4 weeks treatment period

  • Blood Pressure measurement

    During the 4 weeks treatment period

  • Body Temperature measurement

    During the 4 weeks treatment period

  • +2 more secondary outcomes

Study Arms (2)

Test group (Houtou Jianeweiling tablet )

EXPERIMENTAL

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

Control group (Omeprazole enteric-coated tablet)

ACTIVE COMPARATOR

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

Interventions

Houtou Jianweiling tabletOTHER

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.

Also known as: Traditional Chinese Medicine (TCM)
Test group (Houtou Jianeweiling tablet )
Omeprazole TabletDRUG

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.

Also known as: Active comparator
Control group (Omeprazole enteric-coated tablet)

Eligibility Criteria

Age18 Years - 65 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • (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.

You may not qualify if:

  • (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.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

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

Karachi, 75270, Pakistan

Location

Related Publications (1)

  • Shah MR, Fatima S, Khan SN, Shafiullah, Azam Z, Shaikh H, Majid S, Chengdong H, Daijun Z, Wang W. The safety and efficacy of Houtou Jianweiling tablet in patients with chronic non-atrophic gastritis: a double-blind, non-inferiority, randomized controlled trial. Front Pharmacol. 2024 Feb 19;15:1293272. doi: 10.3389/fphar.2024.1293272. eCollection 2024.

    PMID: 38440179DERIVED

MeSH Terms

Conditions

Gastritis

Interventions

Medicine, Chinese TraditionalOmeprazole

Condition Hierarchy (Ancestors)

GastroenteritisGastrointestinal DiseasesDigestive System DiseasesStomach Diseases

Intervention Hierarchy (Ancestors)

Medicine, East Asian TraditionalMedicine, TraditionalComplementary TherapiesTherapeutics2-PyridinylmethylsulfinylbenzimidazolesSulfoxidesSulfur CompoundsOrganic ChemicalsPyridinesHeterocyclic Compounds, 1-RingHeterocyclic CompoundsBenzimidazolesHeterocyclic Compounds, 2-RingHeterocyclic Compounds, Fused-Ring

Study Design

Study Type
interventional
Phase
phase 2
Allocation
RANDOMIZED
Masking
DOUBLE
Who Masked
PARTICIPANT, INVESTIGATOR
Masking Details
Double Blind
Purpose
TREATMENT
Intervention Model
PARALLEL
Model Details: Randomized, Double-Blind, Placebo-Controlled, Non-inferiority Clinical Trial
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Professor

Study Record Dates

First Submitted

November 28, 2020

First Posted

December 17, 2020

Study Start

November 8, 2022

Primary Completion

February 2, 2023

Study Completion

February 2, 2023

Last Updated

April 18, 2023

Record last verified: 2023-04

Data Sharing

IPD Sharing
Will not share

Locations

PA(1)