Common ColdPhase 3NCT06697886
A Study of the Efficacy and Safety of Antiwei Granules in the Treatment of Common Cold
A Phase 3 study testing Antiwei Granules in people with Common Cold, run by Tasly Pharmaceutical Group Co., Ltd at 24 sites in China.
Trial summary
To further evaluate the efficacy and safety of Antiwei granule in the treatment of common cold (wind-cold syndrome) Read more about this study
- Who is it for?
- Ages 18 to 65 years
- Conditions the study is for
- Common Cold
- What is being tested?
- Antiwei Granules
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 480 participants
- Where
- 24 sitesChina
- Study dates
- 16 Nov 2023to 1 Jul 2025
- Phase
- Phase 3
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 65 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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.
Who cannot join
- 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；
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- 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).
Trial locations and contacts
24 sites in 1 country. Contact the study team or a site near you to ask about taking part.
24 sites in 1 country
China24 sites, 24 recruiting
- Recruiting
Beijing Hospital of Traditional Chinese Medicine, Capital Medical University
Beijing
Qingquan Liu, 010-64011516, liuqingquan2003@126.com
- Recruiting
changsha Hospital Affiliated to Hunan University
Changsha
Zhi Xiao, 25171012@qq.com
- Recruiting
Chengdu Pidu District Hospital of TCM
Chengdu
Hua Wei, 27081680@qq.com
- Recruiting
Heilongiang Provincial Traditional Chinese Medicine Hospital
Haerbin
Baihua Jiang, jiangbaihua2007@sohu.com
- Recruiting
The Second Affiliated Hospital of Heilongjiang University of Chinese Medicine
Haerbin
Shanjun Yang, ysj119@126.com
- Recruiting
Huizhou Third People's Hospital
Huizhou
Wutie Zhou, 79869514@qq.com
- Recruiting
Kaifeng Hospital of Traditional Chinese Medicine
Kaifeng
Qixiang Wu, wqxly2005@163.com
- Recruiting
Luoyang Third People's Hospital
Luoyang
Min Zhou, 910637973@qq.com
- Recruiting
The Affiliated Traditional Chinese Medicine Hospital, Southwest Medical University
Luzhou
Suhua Ao, 463787216@qq.com
- Recruiting
The Affiliated Hospital of Jiangxi Uniwersity of TCM
Nanchang
Yuanbing Zhang, ybzhang68@sohu.com
- Recruiting
Panjin Liaoyou Baoshihua Hospital
Panjin
Hongmei Qu, 4663168@qq.com
- Recruiting
Quzhou People's Hospital
Quzhou
Xuru Jin, wzjxr@qq.com
- Recruiting
Sanmenxia Central Hospital
Sanmenxia
Shuaisen Sun, 509035597@qq.com
- Recruiting
Longhua Hospital, Shanghai University of Traditional Chinese Medicine,
Shanghai
Honghao Xue, 13917327582@163.com
- Recruiting
Shangqiu First People's Hospital
Shangqiu
Weihua Zhang, 63zwh@163.com
- Recruiting
The Second Affiliated Hospital of Liaoning University of Traditional Chinese Medcine
Shenyang
Xuefeng Yu, yu8282@163.com
- Recruiting
Hebei Provincial Hospital of Traditional Chinese Medicine
Shijiazhuang
yinghao su, 8242486690@qq.com
- Recruiting
The Second Affiliated Hospital of Tianjin University of Traditional Chinese Medicine
Tianjin
Wanpeng Gao, gaowanp@sina.com
- Recruiting
Tonghua Central Hospital
Tongzhou
Ming Li, 339558371@qq.com
- Recruiting
The Second Affiliated Hospital of Shaanxi University of Chinese Medicine
Xi'an
Tianhao Li, lth2009113@126.com
- Recruiting
Xidian Group Hospital
Xi'an
Zhiwen Xue, xzw1232002@sina.com
- Recruiting
The Second Affiliated Hospital of Xingtai Higher Medical College
Xingtai
Rongge Liu, Rglyz_happy@126.com
- Recruiting
Yangquan Coal Industry(Group) General Hospital
Yangquan
Ruibin Guo, grb8888@126.com
- Recruiting
Henan Provincial People's Hospital
Zhengzhou
Limin Zhao, zlm9898@126.com
About this study
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
To further evaluate the efficacy and safety of Antiwei granule in the treatment of common cold (wind-cold syndrome)
- Conditions
- Common Cold
- Being tested
- Antiwei Granules, Antiwei Granules Placebo
- Medical subject headings
- Common Cold
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Antiwei GranulesDrug
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 PlaceboDrug
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 group | Role | What they receive |
|---|---|---|
| Antaiwei granules | Experimental | Not described Receives: Drug: Antiwei Granules |
| Antaiwei granules placebo | Placebo comparator | Not described Receives: Drug: Antiwei Granules Placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
cure rate after 3 days of treatment
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.
Measured: 3 days
Secondary outcomes (8)
Time to recovery
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 asked to evaluate their cold-related symptoms since the last evaluation before the first dose, in the morning and evening of D2-D5, and in the morning of D6. Visit 2 occurred on the morning of D6 after the assessment was completed.
If the participant in visit 2 did not reach the recovery criteria according to the investigator's judgment, the diary card was reissued and the cold-related symptoms since the last evaluation were evaluated in the evening of D6, the morning and evening of D7, and the morning of D8
Measured: 3 days
Remission rate after 3 days of treatment
Disease remission criteria: bad wind and cold, nasal congestion, runny nose, body pain, headache, sneezing, pharyngeal itching/sore throat were all asymptomatic or mild, and body temperature to normal (axillary temperature < 37.3 ° C) and was maintained for at least 24 hours.
The ratio of subjects who achieved the remission standard after 3 days of medication was calculated, and whether the remission standard was reached was determined according to the morning and evening evaluation of D2-D5.
Measured: 3 days
Single symptom disappearance rate after 3 days of medication
Single symptoms included bad wind and cold, nasal congestion, runny nose, body pain, headache, sneezing, pharyngeal itching/sore throat .
Single symptom disappearance was defined as the disappearance of each single symptom (axillary temperature < 37.3℃) and maintained for at least 24 hours.
Measured: 3+1 days
Efficacy of TCM syndrome after 3 days of medication
After 3 days of treatment, the proportion of subjects who were cured/better/effective in each group was calculated.Clinical recovery: clinical symptoms and signs basically disappeared or completely disappeared, and the syndrome score decreased by ≥95% compared with the baseline. Marked effect: the clinical symptoms and signs were significantly improved, and the syndrome score was reduced by ≥70% compared with the baseline. Effective: the clinical symptoms and signs were improved, and the syndrome score decreased by ≥30% compared with the baseline; No effect: the clinical symptoms and signs did not change, or even had a trend of aggravation, and the syndrome score decreased less than 30% compared with the baseline.
Measured: 3 days
Changes in single symptom level after 3 days of medication
The change of each symptom score from baseline to 3 days after treatment was calculated.
Single symptom: bad wind and cold, nasal congestion, runny nose, body pain, headache, fever, sneezing, pharyngeal itching/sore throat, cough, fatigue.
Measured: 3 days
Incidence of complications
The proportion of subjects with complications (including acute sinusitis, otitis media, tracheobronchitis, pneumonia, etc.) during the period from the first administration of the trial drug to the completion of the trial was calculated.
Measured: 3 days
Proportion of subjects using emergency medication
If the subject's body temperature (axillary temperature) exceeds 39 ° C during the trial, If the body temperature reaches 38.5℃ or above for 4 hours, or if the patient cannot tolerate it, temporary acetaminophen tablets can be taken according to the doctor's advice.
Measured: 3 days
The cure rate of cough and all cold symptoms after 3 days of treatment
Cough and all cold symptoms recovery criteria: cough, 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.
Measured: 3 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted20 Nov 2024
- Study start16 Nov 2023
- Primary completion25 Jun 2025 (estimated)
- Study completion1 Jul 2025 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Common ColdStudies of the same condition, open and under way.
- More trials run by Tasly Pharmaceutical Group Co., LtdThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 3
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 480 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Tasly Pharmaceutical Group Co., Ltd
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06697886
- Sponsor's protocol ID
- TSL-TCM-ATWKL-Ⅲ
- Status last verified
- Nov 2024
- First submitted
- 18 Nov 2024
- Last updated
- 20 Nov 2024
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 20 Nov 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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
- ClinicalTrials.gov ID
- NCT06697886
- Acronym / sponsor ID
- TSL-TCM-ATWKL-Ⅲ
- Conditions
- Common Cold
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 480 participants (estimated)
- Lead sponsor
- Tasly Pharmaceutical Group Co., LtdIndustry (pharma, biotech, devices)
- Study start
- 16 Nov 2023 (actual)
- Primary completion
- 25 Jun 2025 (estimated)
- Study completion
- 1 Jul 2025 (estimated)
- First posted
- 20 Nov 2024 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
To further evaluate the efficacy and safety of Antiwei granule in the treatment of common cold (wind-cold syndrome)
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Antaiwei granules | Experimental | Drug: Antiwei Granules |
| Antaiwei granules placebo | Placebo comparator | Drug: Antiwei Granules Placebo |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (6 listed)
- 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;
Key exclusion criteria (13 listed)
- 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%;
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Antiwei GranulesDuring the 3-day treatment period, participants will receive 9 sacks of Antiwei granules. Oral administration, 1 sack (6g) per time, 3 times daily. | Drug | Antaiwei granules |
| Antiwei Granules PlaceboDuring the 3-day treatment period, participants will receive 9 sacks of Antiwei granules. Oral administration, 1 sack (6g) per time, 3 times daily. | Drug | Antaiwei granules placebo |
Primary outcome
cure rate after 3 days of treatment
Time frame: 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.
8 secondary outcomes
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
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 20 Nov 2024.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
24 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 3 study testing Antiwei Granules in people with Common Cold, run by Tasly Pharmaceutical Group Co., Ltd at 24 sites in China.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 6 inclusion and 13 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 20 Nov 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 24 sites in China. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Rui Liu (022-86343726, liurui2@tasly.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
cure rate after 3 days of treatment (time frame: 3 days). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 20 Nov 2024.