Status:
COMPLETED
Efficacy and Safety of Houtou Jianweiling Tablet in the Treatment of Chronic Non-Atrophic Gastritis
Lead Sponsor:
University of Karachi
Collaborating Sponsors:
Hunan Xinhui Pharmacy Limited Company
Conditions:
Gastritis
Eligibility:
All Genders
18-65 years
Phase:
PHASE2
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-...
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
- (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
- (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.
Key Trial Info
Start Date :
November 8 2022
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
February 2 2023
Estimated Enrollment :
240 Patients enrolled
Trial Details
Trial ID
NCT04672018
Start Date
November 8 2022
End Date
February 2 2023
Last Update
April 18 2023
Active Locations (1)
Enter a location and click search to find clinical trials sorted by distance.
1
Center for Bioequivalence Studies and Clinical Research (CBSCR), ICCBS, university of Karachi
Karachi, Pakistan, 75270