Chronic Non-Atrophic Gastritis
Conditions
Interventions
Experimental Group:Jinweitai Capsule, 3 capsules tid
Teprenone Capsule Simulator, 1 capsule tid, after meals.
Positive Control Group:Teprenone Capsule, 1 capsule tid,after meals
Jinweitai Capsule Simulator, 3 capsules tid.
Placebo group:Jinweitai Capsule Simulator, 3 capsules tid
Teprenone Capsule Simulator, 1 capsule tid,after meals.
Sponsors
Xiyuan Hospital, China Academy of Chinese Medical Sciences
Eligibility
Sex/Gender
All
Age
18 Years to 65 Years
Inclusion criteria
Inclusion criteria: (1) Meet modern diagnostic criteria for chronic non-atrophic gastritis; (2) Meet TCM syndrome differentiation standards for liver-stomach disharmony (liver-stomach qi stagnation, liver-stomach heat stagnation), spleen-stomach damp-heat, or stomach collateral blood stasis (one of these suffices); (3) Average weekly total score of main symptoms (epigastric pain, epigastric fullness/early satiety, epigastric burning sensation, acid regurgitation/heartburn) during 1-week run-in period =6 points, with =4 days of epigastric pain/fullness score =4 points (weekly average score calculation: total weekly symptom score/observation days); (4) Aged 18-65 (inclusive), any gender; (5) Informed consent signed voluntarily.
Exclusion criteria
Exclusion criteria: (1) TCM syndromes of spleen-stomach deficiency (spleen-stomach qi deficiency, spleen-stomach yang deficiency) or stomach yin deficiency, e.g., poor digestion, poor appetite, loose stools; (2) Gastric surgery within 3 years (excluding simple procedures like perforation repair, appendectomy, or pelvic surgeries like cesarean section); (3) Comorbidities: peptic ulcer, special gastritis types, GERD (reflux esophagitis Los Angeles grade B+), IBS, active gastric bleeding, atrophy (Kimura-Takemoto classification C2+), intestinal metaplasia, dysplasia, or suspected malignancy; (4) G6PD deficiency or severe primary cardiovascular/hepatic/pulmonary/renal/hematologic diseases; (5) History of alcoholism, substance abuse, or mental illness; (6) HADS anxiety/depression score =11; (7) Current H. pylori infection; (8) Continuous use of gastroprotective agents, GI motility drugs, or NSAIDs; (9) Pre-existing conditions affecting independent daily activities or consciousness impairment impacting efficacy evaluation; (10) Allergic constitution (=2 drug/food allergies) or hypersensitivity to study drugs/placebo components; (11) Pregnant/lactating women, pregnancy plans within 6 months, positive pregnancy test, or ineffective contraception during trial (non-pharmacological methods only); (12) Participation in other drug trials within 1 month; (13) Investigator-deemed ineligible for trial participation.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Effective Rate of Total Score Improvement Response for Main Symptoms (Epigastric Pain, Fullness/Early Satiety, Burning Sensation, Acid Regurgitation/Heartburn); | — |
Secondary
| Measure | Time frame |
|---|---|
| Response Rate of Total Score Improvement for Main Symptoms;Response Rate and Effective Rate of Individual Symptom Improvement;Response Time for Individual Symptom Improvement;Weekly Score Changes in CNAG Symptom Grading Scale for Individual Symptoms;Changes in TCM Syndrome Scores;Patient-Reported Outcome Scale for Chronic Gastrointestinal Diseases;Recurrence rate; | — |
Countries
China
Contacts
Public ContactTang Xudong/Zhang Beihua
Xiyuan Hospital, China Academy of Chinese Medical Sciences
Outcome results
None listed