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New treatment option for Acute Pharyngitis
Official title Qinqiao Yan Shu Granules for the Treatment of Acute Pharyngitis (Exterior Wind-Heat Syndrome) Phase II Clinical Trial
ClinicalTrials.gov ID: NCT06932328
What this study is testing
What is Qinqiao Yanshu Granules?
Qinqiao Yanshu Granules is an investigational medicine, given as a pill taken by mouth, being studied as a potential treatment for acute pharyngitis.
Plain-language explanation of the investigational treatment - it is being studied and is not an approved or proven therapy. The study team can confirm the details.
- What it's testing
- Trial Objectives and Exploration Indicators： 1. To explore the improvement effect of different doses of Qinqiao Yanshu Granules on the symptoms/conditions and TCM syndromes of acute pharyngitis (Wind - Heat Exogenous Syndrome), and its effect on shortening the course of the disease.
- Phase 2: a mid-size study of how well it works
- Which group you join is decided by chance.
A plain-language read of the study's public ClinicalTrials.gov listing. The study team confirms the details.
Who can take part
Ages 18 to 65
You may be able to join if
- Meeting the Western medicine diagnostic criteria for acute pharyngitis.
- Meeting the TCM syndrome differentiation criteria for the syndrome of wind-heat invading the exterior.
- The disease course at the time of visit is ≤ 48 hours.
- The VAS score for pharyngeal pain is ≥ 4 points, and the pharyngeal sign score is ≥ 1 point.
- Age between 18 and 65 years old (including the boundary values), regardless of gender.
You likely can't join if
- Those with pharyngeal symptoms or inflammation caused by measles, scarlet fever, agranulocytosis, infectious mononucleosis, influenza, diphtheria...
- Those with concurrent acute sinusitis, acute laryngitis, suppurative tonsillitis, bronchitis, pneumonia.
- Those with a modified Centor score ≥ 2 points, a peak body temperature \> 38.5°C (axillary temperature) within 24 hours before this visit, a white...
- Those with concurrent severe primary diseases of the cardiovascular and cerebrovascular system, liver, kidney, hematopoietic system, endocrine...
- Those with a history of thyroid-related diseases such as hyperthyroidism or hypothyroidism.
- Those with laboratory test results indicating ALT \> 1.2 × ULN, AST \> 1.2 × ULN, or Cr \> 1 × ULN. Any one of these conditions will lead to...
See the full eligibility criteria
- Meeting the Western medicine diagnostic criteria for acute pharyngitis.
- Meeting the TCM syndrome differentiation criteria for the syndrome of wind-heat invading the exterior.
- The disease course at the time of visit is ≤ 48 hours.
- The VAS score for pharyngeal pain is ≥ 4 points, and the pharyngeal sign score is ≥ 1 point.
- Age between 18 and 65 years old (including the boundary values), regardless of gender.
- Voluntarily participating in this clinical trial and signing the informed consent form.
- Those with pharyngeal symptoms or inflammation caused by measles, scarlet fever, agranulocytosis, infectious mononucleosis, influenza, diphtheria, acute epiglottitis, acute carotid arteritis, etc.
- Those with concurrent acute sinusitis, acute laryngitis, suppurative tonsillitis, bronchitis, pneumonia.
- Those with a modified Centor score ≥ 2 points, a peak body temperature \> 38.5°C (axillary temperature) within 24 hours before this visit, a white blood cell count \> 1.2 × ULN, a neutrophil percentage \> 1.2 × ULN, and...
- Those with concurrent severe primary diseases of the cardiovascular and cerebrovascular system, liver, kidney, hematopoietic system, endocrine system, and mental diseases.
- Those with a history of thyroid-related diseases such as hyperthyroidism or hypothyroidism.
- Those with laboratory test results indicating ALT \> 1.2 × ULN, AST \> 1.2 × ULN, or Cr \> 1 × ULN. Any one of these conditions will lead to exclusion.
- Those who have used any other drugs for the treatment of acute pharyngitis, including drugs for relieving pharyngeal pain (such as traditional Chinese medicines, glucocorticoids, non-steroidal anti-inflammatory drugs...
- Those who are allergic to the ingredients or excipients of the test drug.
- Pregnant or lactating women.
- Those suspected of or with a confirmed history of alcohol or drug abuse.
- Patients who have participated in or are currently participating in other clinical trials within the past month.
- Patients considered by the researcher to be unsuitable for participating in this clinical trial.
The study team makes the final eligibility decision.
Where it's taking place
- Harbin, Heilongjiang, China
- Changsha, Hunan, China
- Changchun, Jilin, China
- Jinan, Shandong, China
- Luzhou, Sichuan, China
- Tianjin, Tianjin Municipality, China
- Wenzhou, Zhejiang, China
Questions & answers
Do participants get paid in this trial?
This listing doesn't specify compensation. Many trials still reimburse travel or offer a stipend, so it's worth asking the study team when you connect.
Is it free to join, and do I need insurance?
Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part - confirm specifics with the study team.
How long does this study last?
The listing doesn't state an exact length. The study team walks you through the schedule and number of visits before you decide to enroll.
Who can join this trial?
This study is enrolling all sexes, 18 years to 65 years. The study team makes the final eligibility decision.
Where is this trial taking place?
Study sites include Harbin, Heilongjiang, China; Changsha, Hunan, China; Changchun, Jilin, China; Jinan, Shandong, China; Luzhou, Sichuan, China; Tianjin, Tianjin Municipality, China and 1 more location(s). Enter your location above to see the nearest site and check your eligibility.
Explore other conditions
BridgeMD is an information and trial-matching tool - not medical advice, and not the study sponsor. Details come from ClinicalTrials.gov; the study team decides eligibility.