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Phase III study for Cui-Tang Granules in the Treatment of Influenza

A multicenter, phase III, randomized, blind, controlled trial for the efficacy and safety of Cuitang Granules in the treatment of Influenza

Status
Recruiting
Phases
Phase 3
Study type
Interventional
Source
ChiCTR
Registry ID
ChiCTR1900020945
Enrollment
Unknown
Registered
2019-01-22
Start date
2019-01-22
Completion date
Unknown
Last updated
2019-01-28

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

Conditions

Influenza

Interventions

Group 1:Cui-Tang granules
Group 2:Cui-Tang pills

Sponsors

Beijing Hospital of Traditional Chinese Medicine affiliated to Capital Medical University
Lead Sponsor

Eligibility

Sex/Gender
All
Age
18 Years to 65 Years

Inclusion criteria

Inclusion criteria: (1) According to the diagnosis of influenza; (2) Flu rapid antigen test results are positive; (3) Body temperature (under axilla) 37.8 to 39.0 degree C at the time of consultation; (4) The course of influenza is within 48 hours; (5) TCM syndrome differentiation is wind-cold and internal heat syndrome; (6) Aged 18-65 years old; (7) Those who voluntarily sign the informed consent.

Exclusion criteria

Exclusion criteria: (1) Severe flu patients or critically ill patients; (2) The total number of white blood cells in blood routine examination > 11.0 *10^9/L, or the percentage of neutrophils > 80%, or CRP exceeding the upper limit of reference value; (3) Patients with acute episodes of upper respiratory tract diseases such as sinusitis, allergic rhinitis, chronic pharyngitis, tonsillitis, herpes angina were diagnosed; (4) Complicated with lower respiratory tract infection (such as pneumonia, acute, chronic bronchitis, bronchiectasis); (5) During the course of the disease, those who had taken antiviral drugs,antibiotics or traditional Chinese medicine for treating influenza before admission to the group; (6) Patients who have received influenza vaccine within 1 year; (7) Patients with BMI >30; (8) Patients complicated with serious primary diseases such as heart, lung, brain and hematopoietic system or malignant tumors; (9) Drug allergies to test drugs, including those who have allergic history to the ingredients of the product, paracetamol or pharmaceutical excipients; (10) Women in pregnancy or planned pregnancy, breast-feeding women, who are unable or unwilling to take adequate contraception during the trial or whose spouses are unwilling to take contraceptive measures; (11) Psychiatric subjects and those unable to cooperate with clinical trials; (12) Those who have participated in other clinical trials within four weeks or are participating in other drug clinical trials at present; (13) Doctors do not consider it appropriate for the patient to participate in clinical trials.

Design outcomes

Primary

MeasureTime frame
3 days antipyretic rate;

Secondary

MeasureTime frame
Onset time of antipyretic;Body temperature recovery time;Improvement of main clinical symptoms (cough, headache, joint soreness);Clinical curative effect of influenza;TCM syndrome curative effect;Administration of paracetamol tablets;

Countries

China

Contacts

Public ContactQingquan Liu

Beijing hospital of Traditional Chinese Medicine affiliated to Capital Medical University

liuqingquan2003@126.com+86 18910566722

Outcome results

None listed

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