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Phase II clinical trial of Liwei capsule in the treatment of chronic superficial gastritis with erosion dampness-heat stasis

The safety and efficacy of Liwei capsule in the treatment of chronic superficial gastritis with erosive dampness-heat stasis: a randomized, double-blind, multicentre parallel controlled Phase II clinical trial

Status
Active, not recruiting
Phases
Phase 2
Study type
Interventional
Source
ChiCTR
Registry ID
ChiCTR2100052010
Enrollment
Unknown
Registered
2021-10-13
Start date
2012-10-16
Completion date
Unknown
Last updated
2022-06-27

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

Conditions

Chronic Erosive Gastritis

Interventions

Experimental group:LiWei capsule
Positive control group:Sanjiu Weitai capsule
Placebo group:Placebo

Sponsors

Jiangsu Hospital of Traditional Chinese Medicine
Lead Sponsor

Eligibility

Sex/Gender
All
Age
18 Years to 65 Years

Inclusion criteria

Inclusion criteria: 1. It conforms to the western diagnostic criteria of chronic superficial gastritis with erosion. 2. It conforms to the standard of TCM syndrome differentiation of dampness-heat stasis. 3. The age range is 18 to 65, regardless of gender. 4. Informed consent,voluntary subjects.The process of obtaining informed consent shall comply with GCP regulations.

Exclusion criteria

Exclusion criteria: 1. Chronic atrophic gastritis;Other secondary gastritis;Combined with gastric and duodenal ulcers;Gastric mucosa with severe dysplasia or pathological diagnosis suspected malignant change. 2. Relevant drugs have been used within one week after the onset of the disease. 3. Pregnant and lactating women. 4. Have serious primary heart/liver/lung/kidney/blood or serious disease affecting their survival,such as cancer or AIDS; Renal dysfunction; ALT > 2N; WBC < 3.0 x 10^9/L. 5. Inability to give fully informed consent due to mental or behavioural disorders. 6. Suspected or confirmed history of alcohol or drug abuse. 7. Other lesions that,in the investigator's judgment,reduce or complicate enrollment,Such as frequent changes in the work environment and other easy to cause loss of follow-up. 8. Allergic constitution,such as two or more drugs or food allergy history;Or known to be allergic to the drug ingredients. 9. Patients who are participating in clinical trials for other drugs.

Design outcomes

Primary

MeasureTime frame
Electronic gastroenteroscopy;Histopathology;

Secondary

MeasureTime frame
Helicobacter pylori;Ultrasonic;

Countries

China

Contacts

Public ContactShutang Han

General Hospital of Northern Theater Command

shutanghanhst@163.com+86 25 86555033

Outcome results

None listed

Source: ChiCTR (via WHO ICTRP) · Data processed: Feb 6, 2026