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Recruiting Phase 3

A Study of the Efficacy and Safety of Antiwei Granules in the Treatment of Common Cold

NCT06697886 · tracked via the Priya Life Science China tracker
Phase
Phase 3
Started
2023-11-16
Last updated
2024-11-20

Condition(s) studied

Common Cold

Investigational drug(s) / intervention(s)

Antiwei GranulesAntiwei Granules Placebo

Antiwei Granules: During the 3-day treatment period, participants will receive 9 sacks of Antiwei granules. Oral administration, 1 sack (6g) per time, 3 times daily.

Antiwei Granules Placebo: During the 3-day treatment period, participants will receive 9 sacks of Antiwei granules. Oral administration, 1 sack (6g) per time, 3 times daily.

Study summary

To further evaluate the efficacy and safety of Antiwei granule in the treatment of common cold (wind-cold syndrome)

Eligibility

Sex
ALL
Min age
18 Years
Max age
65 Years
Healthy volunteers
No
Inclusion Criteria: 1. It met the diagnostic criteria of common cold in western medicine; 2. In accordance with the TCM syndrome differentiation standard of wind-cold syndrome; 3. Male and female patients aged 18 to 65 years; 4. The disease duration at enrollment was ≤48 h; 5. At enrollment, 37.3 ° C ≤axillary temperature \< 38.5 ° C; 6. Informed consent was obtained voluntarily. Exclusion Criteria: 1. Complicated with influenza, pneumonia, suppurative tonsillitis, acute tracheobronchitis, acute pharyngeal conjunctivitis, acute viral or herpetic pharyngitis, acute viral or herpetic laryngitis; 2. Patients who had been infected with 2019-ncov in the past and still had symptoms such as cough and fatigue for nearly 3 months after the antigen turned negative; 3. Primary ciliary dyskinesia syndrome, other acute onset nasal diseases (such as allergic rhinitis, chronic rhinitis, acute and chronic sinusitis, etc.), previous nasal surgery or radiotherapy of the nasopharynx with nasal mucosal dysfunction; 4. Patients with chronic respiratory diseases (such as chronic obstructive pulmonary disease, interstitial lung disease, etc.), asthma, and tuberculosis; 5. White blood cell count \>12.0×10\^9/L or \<3.0×10\^9/L , And/or neutrophil percentage \>80%; 6. Aspartate aminotransferase and/or alanine aminotransferase ≥ 1.5 × ULN, or serum creatinine ≥ ULN, judged by the investigator to be clinically significant; 7. Combined with other serious primary diseases of the heart, brain, lung, liver, kidney or blood system, such as unstable control/serious complications of diabetes, viral hepatitis, hemophilia, or mental disorders; 8. Patients who had been treated with Chinese and western drugs for the relief of common cold and its symptoms after the onset of the current illness, including but not limited to antibiotics, antiviral, antihistamine, steroids, decongestants, antipyretic and analgesic, antitussive and expectorant drugs etc; 9. Those who were allergic to the known composition of the investigational drug or to emergency medication, or emergency drug contraindication population; 10. The participants (and their partners) had planned pregnancy or were unwilling to take appropriate contraceptive measures from enrollment to 1 month after the end of the trial, or were pregnant or lactating; 11. Suspected or true history of alcohol or drug abuse; 12. Participants who had participated in another clinical trial within 1 month before enrollment; 13. Persons deemed unsuitable for clinical trial by the investigator (e.g., athletes or persons not eligible for enrollment for other reasons).

Primary outcome measure(s)

  • cure rate after 3 days of treatment — 3 days
    Disease recovery criteria: bad wind and cold, nasal congestion, runny nose, body pain, headache, sneezing, pharyngeal itching/sore throat symptoms were all relieved and body temperature to normal (axillary temperature \< 37.3 ° C) and was maintained for at least 24 hours. Subjects were required to be treated before the first dose, D2-Cold-related symptoms since the last evaluation were evaluated in the morning and evening of D5 and in the morning of D6, respectively.

Trial sites (24)

FacilityCityRegionStatus
Beijing Hospital of Traditional Chinese Medicine, Capital Medical University Beijing China Recruiting
changsha Hospital Affiliated to Hunan University Changsha China Recruiting
Chengdu Pidu District Hospital of TCM Chengdu China Recruiting
Heilongiang Provincial Traditional Chinese Medicine Hospital Haerbin China Recruiting
The Second Affiliated Hospital of Heilongjiang University of Chinese Medicine Haerbin China Recruiting
Huizhou Third People's Hospital Huizhou China Recruiting
Kaifeng Hospital of Traditional Chinese Medicine Kaifeng China Recruiting
Luoyang Third People's Hospital Luoyang China Recruiting
The Affiliated Traditional Chinese Medicine Hospital, Southwest Medical University Luzhou China Recruiting
The Affiliated Hospital of Jiangxi Uniwersity of TCM Nanchang China Recruiting
Panjin Liaoyou Baoshihua Hospital Panjin China Recruiting
Quzhou People's Hospital Quzhou China Recruiting
Sanmenxia Central Hospital Sanmenxia China Recruiting
Longhua Hospital, Shanghai University of Traditional Chinese Medicine, Shanghai China Recruiting
Shangqiu First People's Hospital Shangqiu China Recruiting
The Second Affiliated Hospital of Liaoning University of Traditional Chinese Medcine Shenyang China Recruiting
Hebei Provincial Hospital of Traditional Chinese Medicine Shijiazhuang China Recruiting
The Second Affiliated Hospital of Tianjin University of Traditional Chinese Medicine Tianjin China Recruiting
Tonghua Central Hospital Tongzhou China Recruiting
The Second Affiliated Hospital of Shaanxi University of Chinese Medicine Xi'an China Recruiting
Xidian Group Hospital Xi'an China Recruiting
The Second Affiliated Hospital of Xingtai Higher Medical College Xingtai China Recruiting
Yangquan Coal Industry(Group) General Hospital Yangquan China Recruiting
Henan Provincial People's Hospital Zhengzhou China Recruiting
Official registry record

This page summarises publicly available registry data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.

View NCT06697886 on ClinicalTrials.gov ↗ ← All trials in China