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Trial Objectives and Exploration Indicators:
Sample Size:It is planned to enroll 72 cases in each group (high - dose group, low - dose group, and extremely low - dose group), with a total of 216 cases.
Investigational Products:Experimental groups:
Control group:
(1) Extremely low - dose group: Specification: 12g/bag.
Rescue medication:
(1) Paracetamol tablets: Specification: 0.5g/tablet. Dosage and Administration: High - dose group: Dissolve in boiling water and take 1 bag each time, 3 times a day, half an hour before meals; Low - dose group: Dissolve in boiling water and take 1 bag each time, 3 times a day, half an hour before meals; Extremely low - dose group: Dissolve in boiling water and take 1 bag each time, 3 times a day, half an hour before meals; Rescue medication: Paracetamol tablets. During the trial, if the subject's body temperature exceeds 38.5°C (including 38.5°C), rescue medication can be added. Use it according to the instructions and doctor's advice and record it truthfully.
Treatment Course:5 days Efficacy Indicators:
1) The disappearance rate of pharyngeal pain 3 days and 5 days after treatment; 2) The change value of the pharyngeal pain VAS score compared with the baseline 5 days after treatment; 3) The time to disappearance of pharyngeal pain; 4) The effective rate of pharyngeal signs 5 days after treatment; 5) The clinical cure rate of the disease 5 days after treatment; 6) The efficacy of TCM syndromes 5 days after treatment; 7) The disappearance rate of single symptoms 5 days after treatment; 8) The frequency of rescue drug use. Measurement and Definition of Endpoint Indicators:
The criterion for the disappearance of pharyngeal pain: The pharyngeal pain VAS score drops to 0 points and persists for 24 hours or more.
Pharyngeal pain VAS score:
Starting from the evaluation time of the VAS score during the screening period, the subject evaluates once every 24 hours (±1 hour) and records the most severe degree of pharyngeal pain in the past 24 hours in the diary card.
The criterion for the effective rate of pharyngeal signs: "Effective" is defined as a decrease of at least 1 point in the pharyngeal sign score. The effective rate = (Number of effective cases / Total number of cases) × 100%.
The criterion for the clinical cure of the disease: The clinical symptoms of the disease disappear, and the pharyngeal signs are reduced to mild or less. The cure rate = (Number of cured cases / Total number of cases) × 100%.
The definition of the efficacy of TCM syndromes:
Efficacy of TCM syndromes: Cure means that the TCM syndrome score decreases by ≥ 95%; Marked effect means that the TCM syndrome score decreases by ≥ 70% and < 95%; Effective means that the TCM syndrome score decreases by ≥ 30% and < 70%; Ineffective means that it does not meet the above criteria.
The change value of the pharyngeal pain VAS score compared with the baseline = The baseline pharyngeal pain VAS score - The pharyngeal pain VAS score on the 6th day.
Study Populationï¼›
Inclusion criteria:
Exclusion criteria:
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Qinqiao Yanshu Granules High - dose group | Experimental |
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| Qinqiao Yanshu Granules Low - dose group | Experimental |
| |
| Qinqiao Yanshu Granules Extremely low - dose group | Experimental |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Qinqiao Yanshu Granules | Drug | High - dose group: Dissolve in boiling water and take 1 bag each time, 3 times a day, half an hour before meals; Low - dose group: Dissolve in boiling water and take 1 bag each time, 3 times a day, half an hour before meals; Extremely low - dose group: Dissolve in boiling water and take 1 bag each time, 3 times a day, half an hour before meals; Rescue medication: Paracetamol tablets. During the trial, if the subject's body temperature exceeds 38.5°C (including 38.5°C), rescue medication can be added. Use it according to the instructions and doctor's advice and record it truthfully. |
| Measure | Description | Time Frame |
|---|---|---|
| The disappearance rate of pharyngeal pain 3 and 5 days after treatment | 3days/5days |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Gang Zhao | Contact | 86+02784514002 | 158200458@qq.com |
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| The First Affiliated Hospital of Heilongjiang University of Chinese Medicine | Recruiting | Harbin | Heilongjiang | 150000 | China |
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| The First Affiliated Hospital of Hunan University of Chinese Medicine | Recruiting | Changsha | Hunan | 410000 | China |
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| Affiliated Hospital of Changchun University of Chinese Medicine | Recruiting | Changchun | Jilin | 130000 | China |
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| Affiliated Hospital of Shandong University of Traditional Chinese Medicine | Recruiting | Jinan | Shandong | 250000 | China |
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| The Affiliated Traditional Chinese Medicine Hospital of Southwest Medical University | Recruiting | Luzhou | Sichuan | 646000 | China |
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| First Affiliated Hospital of Tianjin University of Traditional Chinese Medicine | Recruiting | Tianjin | Tianjin Municipality | 300110 | China |
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| Wenzhou Hospital of Traditional Chinese Medicine | Recruiting | Wenzhou | Zhejiang | 325000 | China |
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