Recruiting NCT06697886
A Study of the Efficacy and Safety of Antiwei Granules in the Treatment of Common Cold
For patients and families
In plain language
An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.
- What is being studied
- The protocol lists: Antiwei Granules, Antiwei Granules Placebo.
- Who it may be relevant to
- Registry conditions: Common Cold. Basic parameters: 18 years — 65 years · All.
- What needs checking
- Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
- Where it takes place
- China
- Next step
- Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
Unsure about the terms? Read our patient guide →
Official title
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
Overview
To further evaluate the efficacy and safety of Antiwei granule in the treatment of common cold (wind-cold syndrome)
Interventions
- Drug 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. - Drug 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.
Primary outcome measures
- cure rate after 3 days of treatment [Time frame: 3 days]
Secondary outcome measures (8)
- Time to recovery [Time frame: 3 days]
- Remission rate after 3 days of treatment [Time frame: 3 days]
- Single symptom disappearance rate after 3 days of medication [Time frame: 3+1 days]
- Efficacy of TCM syndrome after 3 days of medication [Time frame: 3 days]
- Changes in single symptom level after 3 days of medication [Time frame: 3 days]
- Incidence of complications [Time frame: 3 days]
- Proportion of subjects using emergency medication [Time frame: 3 days]
- The cure rate of cough and all cold symptoms after 3 days of treatment [Time frame: 3 days]
Eligibility criteria
Inclusion criteria
- 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.
Exclusion criteria
- 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).
Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.
Healthy volunteers: No
Study design
- Allocation
- Randomized
- Model
- Parallel assignment
- Masking
- Quadruple blind
- Primary purpose
- Treatment
Study locations
China · 24 centers
- Beijing Hospital of Traditional Chinese Medicine, Capital Medical University — Beijing
- changsha Hospital Affiliated to Hunan University — Changsha
- Chengdu Pidu District Hospital of TCM — Chengdu
- 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
- … and 16 more centers
Identifiers
NCT: NCT06697886 · TSL-TCM-ATWKL-Ⅲ