Skip to content

Sodium Azulensulfonate Tablets versus Placebo for chronic gastritis (active phase): a randomized, multi-centered,double-blinded trial

Sodium Azulensulfonate Tablets versus Placebo for chronic gastritis (active phase): a randomized, multi-centered,double-blinded trial

Status
Active, not recruiting
Phases
Phase 4
Study type
Interventional
Source
ChiCTR
Registry ID
ChiCTR-IPR-15005765
Enrollment
Unknown
Registered
2014-12-29
Start date
2009-02-01
Completion date
Unknown
Last updated
2017-04-18

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Chronic gastritis

Interventions

experiment group:Sodium Azulensulfonate Tablets
control group:Placebo

Sponsors

Gastroenterology department of West China Hospital, Sichuan University
Lead Sponsor

Eligibility

Sex/Gender
All
Age
18 Years to 65 Years

Inclusion criteria

Inclusion criteria: 1. inpatient or outpatient; 2. aged between 18 to 65 years, no gender limit; 3. clinical or gastroscopic diagnosed with chronic gastritis(active stage); 4. sign the informed consent; 5. agree with the requirements of the research plan and regular assessment.

Exclusion criteria

Exclusion criteria: 1. complicated with peptic ulcer, high grade gastric dysplasia or was suspected malignant; transformation pathologically; 2. diagosed with peptic ulcer and underwent surgery for complication within 30 days, or had a history of gastrectomy, gastrointestinal anastomosis; 3. co-morbidity or complication that may effect efficacy observation or contradict to the experimental drug; 4. serious co-morbidity with heart, brain, lung, liver(liver function: ALT, AST is two times greater than the upper limit, or total bilirubin is 1.5 times greater than the upper limit), kidney(abnormal creatine) or hypertension (level 3 or above; 5. Pregnant, preparing to get pregnant, or nursing mothers; 6. alcoholic, drug addict or other unsuitable participant for drug trial; 7. prone to allergy; 8. participate in other drug trial within 3 months; 9. with the necessity to take drugs (such as acid-inhibitors, mucosa protectant, antibiotic) that may interfere with efficacy observation one week before the trial or within the trial 10. other participants that were considered unsuitable by doctors.

Design outcomes

Primary

MeasureTime frame
gastroscopic efficacy;

Secondary

MeasureTime frame
pathological efficacy;symptomatic efficacy;

Countries

China

Contacts

Public ContactTang Chengwei
shcqcdmed@163.com+86 18980601275

Outcome results

None listed

Source: ChiCTR (via WHO ICTRP) · Data processed: Feb 4, 2026