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Re Dune Granules for the Treatment of Influenza (Wind-Heat Pattern): A Randomized, Double-Blind, Placebo-Controlled, Dose-Finding, Multicenter Phase II Clinical Trial

Re Dune Granules for the Treatment of Influenza (Wind-Heat Pattern): A Randomized, Double-Blind, Placebo-Controlled, Dose-Finding, Multicenter Phase II Clinical Trial

Status
Active, not recruiting
Phases
Phase 2
Study type
Interventional
Source
ITMCTR
Registry ID
ITMCTR2025002292
Enrollment
Unknown
Registered
2025-11-21
Start date
2021-06-18
Completion date
Unknown
Last updated
2025-12-08

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

Conditions

Influenza

Interventions

High-dose group:Reedone Granules, 3 packets each time, taken with warm water, twice daily.
Low-dose group:2 packets of Heruoning granules + 1 packet of placebo (Heruoning granules simulator), dissolve in warm water, twice daily.
Placebo group:Placebo (simulator of Re Duxing granules), 3 packets per dose, dissolved in warm water, twice daily.

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. Meets the clinical diagnostic criteria for influenza; 2. The result of the influenza virus antigen detection kit for nasopharyngeal secretions is positive; 3. Meets the diagnostic criteria for wind-heat syndrome in traditional Chinese medicine; 4. At the time of consultation, body temperature (axillary) is between 37.5 ? and 39.5 ? (inclusive of 37.5 ? and exclusive of 39.5 ?); 5. Duration of illness = 48 hours (the time interval from onset of illness to the first consultation does not exceed 48 hours); 6. Age is between 18 and 65 years (inclusive of 18 and 65 years of age); 7. The informed consent process meets ethical requirements, and the participant has signed the informed consent form.

Exclusion criteria

Exclusion criteria: 1. Clinically diagnosed as severe or critical influenza; 2. With other types of respiratory infections, including acute rhinitis, sinusitis, tracheobronchitis, and pneumonia; 3. Routine blood tests show a total white blood cell count exceeding the upper limit of normal, or a neutrophil percentage exceeding 80%, or symptoms of purulent sputum, suggesting bacterial infection; 4. With severe malnutrition, rickets, or severe primary diseases of the cardiovascular, cerebrovascular, hepatic, renal, or hematopoietic systems; 5. Immunodeficiency or having taken glucocorticoids or other immunosuppressive agents within the past week; 6. Body Mass Index (BMI) > 30; 7. Having received treatment with antiviral medications such as oseltamivir, peramivir, or arbidol before this visit during the current illness course; 8. Having received a flu vaccine within the past year; 9. Allergy to the investigational drug, including its components, acetaminophen tablets, or any excipients; 10. Pregnant women, women planning pregnancy within the next 3 months, or breastfeeding women; fertile women or their partners unwilling or unable to use adequate contraception during the study or within 1 month after the last dose; 11. History of suspected or confirmed alcohol or substance abuse; 12. Participation in other clinical trials within the past month or currently participating in other drug clinical trials; 13. Investigators deem it inappropriate to participate in this clinical trial.

Design outcomes

Secondary

MeasureTime frame
Onset time of fever reduction;Time to return to normal body temperature;Time to disappearance and disappearance rate;Clinical recovery time, Clinical recovery rate;Composite Score of Influenza Symptoms - Time AUC;The usage quantity and frequency of antipyretic analgesics;

Primary

MeasureTime frame
Time to Relief of Influenza Symptoms;

Countries

China

Contacts

Public ContactLiu Qingquan

Beijing Hospital of Traditional Chinese Medicine Affiliated to Capital Medical University

liuqingquan2003@126.com13910055687

Outcome results

None listed

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