Clinical trial NCT04672018: Efficacy and Safety of Houtou Jianweiling Tablet in the Treatment of Chronic Non-Atrophic Gastritis
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
Overall status: COMPLETED
Phase: PHASE2
Conditions: Gastritis
Lead sponsor: University of Karachi
Sponsor class: OTHER
Collaborators: name: Hunan Xinhui Pharmacy Limited Company
First posted: 2020-12-17
Enrollment: 240
Sex: ALL
Minimum age (years): 18
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: Randomized, Double-Blind, Placebo-Controlled, Non-inferiority Clinical Trial
Primary purpose: TREATMENT

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.

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.

Primary outcomes:
measure: The improvement rate of main Clinical symptoms
timeFrame: During the four-week trial period
measure: Physicians Global Assessment to measure quality of life (PGA)
timeFrame: During the four-week trial period
Secondary outcomes:
measure: Laboratory examinations
timeFrame: before enrollment and within 5 days after treatment
measure: Pulse rate measurement
timeFrame: During the 4 weeks treatment period
measure: Respiration rate measurement
timeFrame: During the 4 weeks treatment period
measure: Blood Pressure measurement
timeFrame: During the 4 weeks treatment period
measure: Body Temperature measurement
timeFrame: During the 4 weeks treatment period
measure: Electrocardiogram
timeFrame: before enrollment and within 5 days after treatment
measure: Stool test for H. Pylori
timeFrame: within 5 days after treatment
Other outcomes:
Locations:
city: Karachi
country: Pakistan
facility: Center for Bioequivalence Studies and Clinical Research (CBSCR), ICCBS, university of Karachi
Study officials:
References: