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Effectiveness and safety of Crocin tablets in the treatment of cardiac manifestions (syndrome of blood stasis) in patients with post-coronavirus disease 2019 condition: a randomized, double-blind, placebo-controlled clinical tria

Effectiveness and safety of Crocin tablets in the treatment of cardiac manifestions (syndrome of blood stasis) in patients with post-coronavirus disease 2019 condition: a randomized, double-blind, placebo-controlled clinical tria

Status
Active, not recruiting
Phases
Early Phase 1
Study type
Interventional
Source
ChiCTR
Registry ID
ChiCTR2400082396
Enrollment
Unknown
Registered
2024-03-28
Start date
2023-02-23
Completion date
Unknown
Last updated
2024-04-01

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

Conditions

Novel coronavirus infection

Interventions

Crocin tablets group:Taking Crocin tablets (12mg/ tablet) orally, 4 tablets/time, 3 times/day after each meal for 7 days
Placebo group:Taking placebo tablets (12mg/ tablet) orally, 4 tablets/time, 3 times/day after each meal for 7 days

Sponsors

West China Hospital of Sichuan University
Lead Sponsor

Eligibility

Sex/Gender
All
Age
18 Years to 65 Years

Inclusion criteria

Inclusion criteria: (1) Patients diagnosed with mild and moderate novel coronavirus infection, and the respiratory symptoms have disappeared or eased; (2) The main clinical symptoms were heart involvement such as palpitations and chest tightness; (3) Patients meet the diagnostic criteria of "blood stasis syndrome" in the traditional Chinese medicine (TCM) system; (4) Age 18-65 years old (including 18 years old and 65 years old; (5) Sign the subject's informed consent.

Exclusion criteria

Exclusion criteria: (1) Patients diagnosed with severe or critical forms of novel coronavirus infection; (2) Chest tightness and palpitations caused by chronic lung diseases or cardiovascular and cerebrovascular diseases, such as chronic obstructive pulmonary disease, asthma, chronic pulmonary heart disease, coronary atherosclerotic heart disease, chronic cardiac insufficiency, atrial fibrillation, hypertension, etc.; (3) Complicated with serious lung diseases, such as lung cancer and tuberculosis; (4) Complicated with serious malignant tumors, diseases of the blood and hematopoietic system, gastrointestinal diseases or other serious or progressive diseases of the system; Or combined with severe mental illness, severe cognitive dysfunction, etc., unable to cooperate or unwilling to cooperate; (5) Hepatic and renal insufficiency: ALT or AST > 2 times the upper limit of normal reference value; And/or serum creatinine > 1.5 times the upper limit of normal reference value, or eGFR 10.0×10^9/L; And/or neutrophil (N) classification >80%; (7) Have taken drugs similar to the functional indications of the experimental drugs within the past 1 month; (8) With a long history of alcohol or drug abuse; (9) Women who are pregnant or planning to become pregnant, breastfeeding women; (10) Combined with bleeding disease or bleeding tendency; (11) People who are allergic or allergic to known ingredients of the drug; (12) Participants in other drug clinical trials within the past 1 month; (13) Subjects deemed unsuitable for clinical trials by the investigator.

Design outcomes

Primary

MeasureTime frame
Total effective rate of TCM syndrome score;

Secondary

MeasureTime frame
Myocardial markers test series;TCM syndrome score;recurrence rate;

Countries

China

Contacts

Public ContactLiu Wei

West China Hospital of Sichuan University

liuwei0929@wchscu.cn+86 189 8060 1451

Outcome results

None listed

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