Efficacy and Safety of Houtou Jianweiling Tablet in the Treatment of Chronic Non-Atrophic Gastritis
NCT ID: NCT04672018
Last Updated: 2023-04-18
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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COMPLETED
PHASE2
240 participants
INTERVENTIONAL
2022-11-08
2023-02-02
Brief Summary
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Detailed Description
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Conditions
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
DOUBLE
Study Groups
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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.
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.
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.
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.
Interventions
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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.
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 Intervention Names
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Eligibility Criteria
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Inclusion Criteria
* (2) Age between 18 to 65 years.
* (3) Voluntarily participate the clinical trials and sign informed consent.
Exclusion Criteria
* (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.
18 Years
65 Years
ALL
No
Sponsors
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Hunan Xinhui Pharmacy Limited Company
UNKNOWN
University of Karachi
OTHER
Responsible Party
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Dr. Muhammad Raza Shah
Professor
Locations
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Center for Bioequivalence Studies and Clinical Research (CBSCR), ICCBS, university of Karachi
Karachi, , Pakistan
Countries
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References
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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.
Other Identifiers
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CRO-002-TCM-HTJWT-2019
Identifier Type: -
Identifier Source: org_study_id
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