A Phase 3 interventional study of Antiwei Granules and Antiwei Granules Placebo in Common Cold, sponsored by Tasly Pharmaceutical Group Co., Ltd. Recruiting at 24 sites in China. Open to participants aged 18 Years to 65 Years. Per ClinicalTrials.gov, last updated 2024-11-20.
Sponsored by Tasly Pharmaceutical Group Co., Ltd (part of China Resources Pharmaceutical Group Limited) · Phase 3, Interventional, and Treatment
To further evaluate the efficacy and safety of Antiwei granule in the treatment of common cold (wind-cold syndrome)
219 studies on the registry are indexed under Common Cold; 23 are open to participants now.
This study's planned enrollment of 480 is above the median of 150 across 184 interventional studies indexed under Common Cold.
Browse Common Cold studies →Tasly Pharmaceutical Group Co., Ltd is the lead sponsor of 32 studies on the registry; 17 are open to participants now.
First submitted before Tasly Pharmaceutical Group Co., Ltd became part of China Resources Pharmaceutical Group Limited.
Counted across the registry records on this site, refreshed daily.
Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.
Exclusion Criteria:
Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
Chronic obstructive pulmonary disease: long-term lung disease that makes it hard to breathe out, including emphysema and chronic bronchitis.
Two enzymes measured in a routine blood test of the liver. Higher levels can mean the liver is under strain or damaged. SGPT and SGOT are older names for ALT and AST.
Criteria usually give a limit as a multiple of the upper limit of normal (ULN), often higher when cancer has spread to the liver.
The top of the normal range for a blood test, as set by the laboratory that runs it. Each lab prints its own range next to your result.
“≤ 2.5 × ULN” means the result can be up to two and a half times that top value.
Judged by the study doctor to matter for your health or for the study. It is a doctor’s decision, so ask the study team if you are unsure whether something counts.
Anti-inflammatory medicines such as prednisone, prednisolone and dexamethasone — not the anabolic steroids used for muscle.
Studies differ in what they allow: check which steroid medicines, routes (tablets, injections, creams, inhalers, eye drops) and doses this study accepts.
A drug or device being studied in a clinical trial.
It may be new, or already approved and being studied for another use, dose or form. Criteria often leave out people who took part in another study of one within a recent period, commonly 30 days or five half-lives.
A reason a treatment, test or procedure should not be given to a particular person, such as an allergy, another illness or a medicine they take.
Ways of preventing pregnancy. “Highly effective” methods fail less than 1% of the time a year when used correctly — for example an IUD or an implant.
Criteria usually say which methods count and how long to keep using them after the last dose, sometimes for male participants too. Some studies accept a partner’s vasectomy if it was confirmed successful and that person is the participant’s only sexual partner.
Informed consent
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
COPD
Chronic obstructive pulmonary disease: long-term lung disease that makes it hard to breathe out, including emphysema and chronic bronchitis.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
ALT and AST (liver enzymes)
Two enzymes measured in a routine blood test of the liver. Higher levels can mean the liver is under strain or damaged. SGPT and SGOT are older names for ALT and AST.
Criteria usually give a limit as a multiple of the upper limit of normal (ULN), often higher when cancer has spread to the liver.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
ULN (upper limit of normal)
The top of the normal range for a blood test, as set by the laboratory that runs it. Each lab prints its own range next to your result.
“≤ 2.5 × ULN” means the result can be up to two and a half times that top value.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Clinically significant
Judged by the study doctor to matter for your health or for the study. It is a doctor’s decision, so ask the study team if you are unsure whether something counts.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Corticosteroids (steroids)
Anti-inflammatory medicines such as prednisone, prednisolone and dexamethasone — not the anabolic steroids used for muscle.
Studies differ in what they allow: check which steroid medicines, routes (tablets, injections, creams, inhalers, eye drops) and doses this study accepts.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Investigational drug or device
A drug or device being studied in a clinical trial.
It may be new, or already approved and being studied for another use, dose or form. Criteria often leave out people who took part in another study of one within a recent period, commonly 30 days or five half-lives.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Contraindication
A reason a treatment, test or procedure should not be given to a particular person, such as an allergy, another illness or a medicine they take.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Contraception
Ways of preventing pregnancy. “Highly effective” methods fail less than 1% of the time a year when used correctly — for example an IUD or an implant.
Criteria usually say which methods count and how long to keep using them after the last dose, sometimes for male participants too. Some studies accept a partner’s vasectomy if it was confirmed successful and that person is the participant’s only sexual partner.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Drug: Antiwei Granules
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.
During the 3-day treatment period, participants will receive 9 sacks of Antiwei granules. Oral administration, 1 sack (6g) per time, 3 times daily.
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.
Time frame: 3 days
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
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: 3 days
Started Nov 2023 (actual). Primary completion is estimated for Jun 2025, 19 months after the start.
Of 17 phase 3 interventional studies under Common Cold, half reached primary completion within 7 months of starting (the median), counting those still running; a quarter within 5 and three quarters within 16. This study's planned 19 months is above that.
How these figures are worked out, and which studies are left out of them.
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Tasly Pharmaceutical Group Co., Ltd →