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Clinical study for the severity of gastric and small intestinal mucosal injury and the changing of serum inflammatory factors in patients taking enteric-coated aspirin before and after the treatment of Weikang Capsule

Clinical study for the severity of gastric and small intestinal mucosal injury and the changing of serum inflammatory factors in patients taking enteric-coated aspirin before and after the treatment of Weikang Capsule

Status
Recruiting
Phases
Early Phase 1
Study type
Observational
Source
ChiCTR
Registry ID
ChiCTR1900025451
Enrollment
Unknown
Registered
2019-08-26
Start date
2019-09-01
Completion date
Unknown
Last updated
2019-08-27

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

Conditions

Aspirin related gastric and small intestinal mucosal injury

Interventions

single arm:Weikang Capsule

Sponsors

Beijing Anzhen Hospital, Capital Medical University
Lead Sponsor

Eligibility

Sex/Gender
All
Age
18 Years to 80 Years

Inclusion criteria

Inclusion criteria: 1. Aged 18 to 80 years primary prevention of cardiovascular diseases and who needed taking enteric-coated aspirin for more than 1 month; 2. Agreed to accept the treatment plan of the study; and 3. voluntarily signed an informed consent form.

Exclusion criteria

Exclusion criteria: 1. Taking related drugs which have an effect on the experiment in the last 1 month, including: a. antibiotics, b. various drugs for inhibiting gastric acid secretion, c. microecological preparation, d. cytokines, immunosuppressants and cytotoxic agents, and the like, e. hormone; 2. Contraindications of magnetically controlled capsule endoscopy, include a suspected or known gastrointestinal obstruction, a stenosis, a diverticulum or a diverticulum, a pregnant woman, a prior digestive tract surgery, or a surgical history leading to a change in the structure of the abdominal digestive tract, no surgical condition or rejection of any abdominal operation (as the capsule may need to be removed surgically); 3. Taking other antiplatelet or anticoagulant drugs at the same period; 4. The diagnosis of the capsule endoscopy is digestive tumor; 5. Allergy to aspirin, Weikang capsule, polyethylene glycol electrolyte powder, or high molecular material, and 6. participating in other researchers.

Design outcomes

Primary

MeasureTime frame
Gastric injury Lanza score;Small intestinal injury score;

Secondary

MeasureTime frame
serum TNF-a level;serum IL-1ß level;serum IL-10 level;serum PGE2 level;

Countries

China

Contacts

Public ContactZhang Jie

Beijing Anzhen Hospital, Capital Medical University

zhangjie4155@sina.com+86 13601337670

Outcome results

None listed

Source: ChiCTR (via WHO ICTRP) · Data processed: Feb 22, 2026