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

University of Karachi

Status and phase: Completed; Phase 2

Conditions: Gastritis

Treatments: Other: Houtou Jianweiling tablet; Drug: Omeprazole Tablet

Study type: Interventional

Funder types: Other

Identifiers

NCT04672018

CRO-002-TCM-HTJWT-2019

Details and patient eligibility

About

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.

Full 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.

Enrollment: 240 patients

Sex: All

Ages: 18 to 65 years old

Volunteers: No 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; 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.

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Double Blind

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240 participants in 2 patient groups

Test group (Houtou Jianeweiling tablet )

Experimental group

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.

Treatment:

Other: Houtou Jianweiling tablet

Control group (Omeprazole enteric-coated tablet)

Active Comparator group

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.

Treatment:

Drug: Omeprazole Tablet