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Randomized, double-blind, placebo parallel controlled multicenter clinical trial of coenzyme I for the treatment of fulminant myocarditis

Randomized, double-blind, placebo parallel controlled multicenter clinical trial of coenzyme I for the treatment of fulminant myocarditis

Status
Active, not recruiting
Phases
Phase 1
Study type
Interventional
Source
ChiCTR
Registry ID
ChiCTR2400081355
Enrollment
Unknown
Registered
2024-02-29
Start date
2024-03-01
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

fulminant myocarditis

Interventions

control group:Routine treatment of fulminant myocarditis with medication and physiological saline. 50ml physiological saline, intravenous drip, once a day, medication duration: 10 ± 3 days.
Test group:Routine treatment for fulminant myocarditis plus injection of coenzyme I. Co enzyme I for injection, 50mg per dose (powder injection, 5mg per dose), prepared with 50ml physiological saline,

Sponsors

Tongji Hospital, Tongji Medical College, Huazhong University of Science and Technology
Lead Sponsor

Eligibility

Sex/Gender
All
Age
18 Years to No maximum

Inclusion criteria

Inclusion criteria: According to the diagnostic reference standards agreed upon by Chinese experts in the diagnosis and treatment of adult fulminant myocarditis in 2017, patients diagnosed with fulminant myocarditis

Exclusion criteria

Exclusion criteria: 1) Pregnant or recently pregnant women, lactating women; 2) Coenzyme I, lactose intolerance or lactose allergy; 3) Secondary or primary unconsciousness, cognitive impairment, or abnormal mental behavior; 4) Individuals with a history of severe allergies or infusion reactions in the past; 5) Patients with severe liver and kidney dysfunction: ALT or AST>5 times the upper limit, glomerular filtration rate = 30mL/min/1.73 ?; 6) Engaging in clinical research on other drugs; 7) In addition to the above, the researchers have determined that there are other reasons why it is not suitable to participate in this clinical trial.

Design outcomes

Primary

MeasureTime frame
cTnl;

Secondary

MeasureTime frame
echocardiography;NT-pro BNP;electrocardiogram;

Countries

China

Contacts

Public ContactDaowen Wang

Tongji Hospital, Tongji Medical College, Huazhong University of Science and Technology

dwwang@tjh.tjmu.edu.cn+86 181 6250 1060

Outcome results

None listed

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