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Re Dune Granules for the Treatment of Influenza (Wind-Heat Pattern): A Multi-Center, Randomized, Double-Blind, Placebo-Controlled Parallel Group Phase III Clinical Trial Protocol

Re Dune Granules for the Treatment of Influenza (Wind-Heat Pattern): A Multi-Center, Randomized, Double-Blind, Placebo-Controlled Parallel Group Phase III Clinical Trial Protocol

Status
Active, not recruiting
Phases
Phase 3
Study type
Interventional
Source
ITMCTR
Registry ID
ITMCTR2025002370
Enrollment
Unknown
Registered
2025-12-06
Start date
2023-12-18
Completion date
Unknown
Last updated
2026-01-12

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

Conditions

Influenza

Interventions

Experimental Group:Re Dune Granules, take with warm water, 1 sachet per dose, twice daily
for 5 consecutive days.
Control Group:Re Dune Granules Simulated Agent, take with warm water, 1 sachet per dose, 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. Meets the TCM diagnostic criteria for wind-heat pattern; 3. Disease duration =48 hours (from onset of illness to first visit); 4. Age between 18 and 65 years (inclusive); 5. Positive result for influenza rapid test kit using nasal/throat swab; 6. At the time of visit, axillary temperature =37.5°C and <39.5°C, with at least one item of influenza symptom score =2 points; 7. The subject has given informed consent and signed the informed consent form.

Exclusion criteria

Exclusion criteria: 1. Diagnosed clinically as severe or critical influenza. 2. With acute rhinitis, sinusitis, tracheobronchitis, or other types of respiratory infections. 3. CBC shows total white blood cell count exceeding the upper limit of normal by 10%, or neutrophil percentage exceeding the upper limit of normal by 10%, or presence of purulent sputum symptoms. 4. Diagnosed with severe primary diseases of the cardiovascular, cerebrovascular, hepatic, renal, or hematopoietic systems. 5. Patients with immunodeficiency. 6. History of alcohol or substance abuse. 7. Received influenza vaccination within the past year. 8. Used glucocorticoids or other immunosuppressive agents within the past week. 9. Treated with other medications for influenza, such as antivirals, antibiotics, or traditional Chinese medicine, since the onset of the current illness. 10. Known allergy to components (herbs or excipients) of the investigational drug or to acetaminophen tablets (components or excipients). 11. Pregnant or breastfeeding women. 12. Women or men of childbearing potential who plan to become pregnant within the next month, or who do not plan to become pregnant but are unable or unwilling to use contraceptive measures. 13. Body Mass Index (BMI) >30 or <16. 14. Participation in other clinical trials within the past month or currently participating in other clinical trials. 15. Investigators deem the patient unsuitable for participation in this clinical trial.

Design outcomes

Primary

MeasureTime frame
Time to Relief of Influenza Symptoms;

Secondary

MeasureTime frame
Clinical recovery time;Time to return to normal body temperature;Onset time of fever reduction;Influenza single symptom disappearance time or disappearance rate;The reduction value of the total score of Traditional Chinese Medicine (TCM) syndromes and the efficacy rate.;The usage quantity and frequency of antipyretic analgesics;

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