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Kuaiwei Tablet relieving upper abdominal pain in chronic superficial gastritis: a multicenter, randomized, double-blind, double-simulated, position-controlled clinical study

Kuaiwei Tablet relieving upper abdominal pain in chronic superficial gastritis: a multicenter, randomized, double-blind, double-simulated, position-controlled clinical study

Status
Active, not recruiting
Phases
Phase 4
Study type
Interventional
Source
ChiCTR
Registry ID
ChiCTR2300067610
Enrollment
Unknown
Registered
2023-01-13
Start date
2022-03-01
Completion date
Unknown
Last updated
2024-03-04

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

Conditions

Chronic superficial gastritis superior abdominal pain

Interventions

Experimental group:Kuaiwei tablet, 0.7g/ tablet. Tipredone capsule simulant was the same as control group.
control group:Tipreidone capsule, 50mg/ capsule. Kuaiwei tablet simulation agent in the same trial group

Sponsors

Xiyuan Hospital, China Academy of Chinese Medical Sciences
Lead Sponsor

Eligibility

Sex/Gender
All
Age
18 Years to 70 Years

Inclusion criteria

Inclusion criteria: Inclusion criteria: (1) Patients diagnosed with chronic superficial gastritis; (2) Abdominal pain was the main symptom with pain VAS score >=3. (3) The age between 18 and 70 (including endpoint value) is not limited to gender; (4) Voluntary participants in this study and signed informed consent. Inclusion criteria for the induction period: (1) Subject remains willing to participate in this study; ? The average pain VAS score was >=3 points in the one-week induction period.

Exclusion criteria

Exclusion criteria: (1) Chronic atrophic gastritis (C2 and above), upper gastrointestinal bleeding, peptic ulcer (deep ulcer) and gastrointestinal tumor; (2) Complicated with other serious organic diseases, such as acute cardiovascular and cerebrovascular diseases, acute and chronic pancreatitis, cirrhosis, abnormal liver function (ALT/AST>=2 times the upper limit of normal value), hyperthyroidism, diabetes mellitus with a medical history of more than 10 years, chronic renal insufficiency, hematological diseases, etc.; (3) Patients with nervous system and mental diseases requiring long-term medication; (4) Continuous use of gastrointestinal functional drugs (such as H2RA, PPI, gastric mucosal protective agents, antacids, gastrointestinal movers, anticholinergic drugs, or traditional Chinese medicine with analgesic effects) within 2 weeks; (5) A long history of alcoholism and drug abuse; ? Planned pregnancy, pregnancy or lactation; ? has an allergic history of the drug used; ? The syndrome differentiation of traditional Chinese medicine for stomach Yin deficiency; (9) individuals who have participated in or are participating in other clinical trials within 3 months; The tub researchers have deemed inappropriate for participants in clinical trials.

Design outcomes

Primary

MeasureTime frame
Visual analogue scale (VAS) of upper abdominal pain;Rapid pain relief rate;Secondary symptom score;Clinical Outcome Evaluation Scale (PRO Scale) scores reported by patients with chronic gastrointestinal disease;

Countries

China

Contacts

Public ContactTang Xudong
txdly@sina.com.cn+86 10 6283 5248

Outcome results

None listed

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