Clinical trial
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
Name
CRO-002-TCM-HTJWT-2019
Description
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 arms
Trial start
2022-11-08
Estimated PCD
2023-02-02
Trial end
2023-02-02
Status
Completed
Phase
Early phase I
Treatment
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.
Arms:
Test group (Houtou Jianeweiling tablet )
Other names:
Traditional Chinese Medicine (TCM)
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.
Arms:
Control group (Omeprazole enteric-coated tablet)
Other names:
Active comparator
Size
240
Primary endpoint
The improvement rate of main Clinical symptoms
During the four-week trial period
Physicians Global Assessment to measure quality of life (PGA)
During the four-week trial period
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.
Protocol
{'studyType': 'INTERVENTIONAL', 'phases': ['PHASE2'], 'designInfo': {'allocation': 'RANDOMIZED', 'interventionModel': 'PARALLEL', 'interventionModelDescription': 'Randomized, Double-Blind, Placebo-Controlled, Non-inferiority Clinical Trial', 'primaryPurpose': 'TREATMENT', 'maskingInfo': {'masking': 'DOUBLE', 'maskingDescription': 'Double Blind', 'whoMasked': ['PARTICIPANT', 'INVESTIGATOR']}}, 'enrollmentInfo': {'count': 240, 'type': 'ACTUAL'}}
Updated at
2023-04-18
1 organization
1 product
1 indication
Organization
University of KarachiProduct
OmeprazoleIndication
Gastritis