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

Официальное название

To Evaluate the Efficacy and Safety of Antiwei Granules in the Treatment of Common Cold (Wind-cold Syndrome) in a Multicenter, Randomized, Double-blind, Placebo-controlled Phase Ⅲ Clinical Trial

Обзор

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

Вмешательства

• Препарат 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.
• Препарат 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.

Первичные конечные точки

• cure rate after 3 days of treatment [Срок оценки: 3 days]

Вторичные конечные точки (8)

• Time to recovery [Срок оценки: 3 days]
• Remission rate after 3 days of treatment [Срок оценки: 3 days]
• Single symptom disappearance rate after 3 days of medication [Срок оценки: 3+1 days]
• Efficacy of TCM syndrome after 3 days of medication [Срок оценки: 3 days]
• Changes in single symptom level after 3 days of medication [Срок оценки: 3 days]
• Incidence of complications [Срок оценки: 3 days]
• Proportion of subjects using emergency medication [Срок оценки: 3 days]
• The cure rate of cough and all cold symptoms after 3 days of treatment [Срок оценки: 3 days]

Критерии участия

Критерии включения

• It met the diagnostic criteria of common cold in western medicine;
• In accordance with the TCM syndrome differentiation standard of wind-cold syndrome;
• Male and female patients aged 18 to 65 years;
• The disease duration at enrollment was ≤48 h;
• At enrollment, 37.3 ° C ≤axillary temperature < 38.5 ° C;
• Informed consent was obtained voluntarily.

Критерии исключения

• Complicated with influenza, pneumonia, suppurative tonsillitis, acute tracheobronchitis, acute pharyngeal conjunctivitis, acute viral or herpetic pharyngitis, acute viral or herpetic laryngitis;
• 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;
• 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；
• Patients with chronic respiratory diseases (such as chronic obstructive pulmonary disease, interstitial lung disease, etc.), asthma, and tuberculosis;
• White blood cell count >12.0×10\^9/L or <3.0×10\^9/L , And/or neutrophil percentage >80%;
• Aspartate aminotransferase and/or alanine aminotransferase ≥ 1.5 × ULN, or serum creatinine ≥ ULN, judged by the investigator to be clinically significant；
• 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;
• 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;
• Those who were allergic to the known composition of the investigational drug or to emergency medication, or emergency drug contraindication population;
• 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;
• Suspected or true history of alcohol or drug abuse;
• Participants who had participated in another clinical trial within 1 month before enrollment;
• Persons deemed unsuitable for clinical trial by the investigator (e.g., athletes or persons not eligible for enrollment for other reasons).

Критерии приведены из реестра в оригинале (на английском). Окончательную оценку соответствия проводит исследовательский центр.

Здоровые добровольцы: Нет

Дизайн исследования

Распределение

Рандомизированное

Модель

Параллельные группы

Маскирование

Четверное слепое

Основная цель

Лечение

Центры проведения

Китай · 24 центра

• Beijing Hospital of Traditional Chinese Medicine, Capital Medical University — Пекин
• changsha Hospital Affiliated to Hunan University — Чанша
• Chengdu Pidu District Hospital of TCM — Чэнду
• Heilongiang Provincial Traditional Chinese Medicine Hospital — Haerbin
• The Second Affiliated Hospital of Heilongjiang University of Chinese Medicine — Haerbin
• Huizhou Third People's Hospital — Huizhou
• Kaifeng Hospital of Traditional Chinese Medicine — Kaifeng
• Luoyang Third People's Hospital — Luoyang
• … и ещё 16 центров

Идентификаторы

NCT: NCT06697886 · TSL-TCM-ATWKL-Ⅲ

Первоисточники (государственные реестры)

• ClinicalTrials.gov (NIH, США)

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