Qinqiao Yan Shu Granules for the Treatment of Acute Pharyngitis (Exterior Wind-Heat Syndrome) Phase II Clinical Trial

Официальное название

A Randomized, Double-Blind, Dose-Exploration, Multicenter Phase II Clinical Trial to Evaluate the Efficacy and Safety of Qin Qiao Yan Shu Granules in the Treatment of Acute Pharyngitis (Exterior Wind-Heat Syndrome)

Обзор

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. 2. To observe the safety of the clinical application of Qinqiao Yanshu Granules. Overall Trial Design：A block - randomized, double - blind, dose - escalation, multicenter clinical trial design was adopted. 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: 1. High - dose group: Specification: 12g/bag; 2. Low - dose group: Specification: 12g/bag. 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： 1. The criterion for the disappearance of pharyngeal pain: The pharyngeal pain VAS score drops to 0 points and persists for 24 hours or more. 2. 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. 3. 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%. 4. 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%. 5. 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 Population； Inclusion criteria: 1. Meeting the Western medical diagnostic criteria for acute pharyngitis; 2. Meeting the TCM syndrome differentiation criteria for Wind - Heat Exogenous Syndrome; 3. The course of the disease at the time of consultation ≤ 48 hours; 4. The pharyngeal pain VAS score ≥ 4 points and the pharyngeal sign score ≥ 1 point; 5. Aged between 18 and 65 years old (including the boundary values), regardless of gender; 6. Voluntarily participating in this clinical trial and signing the informed consent form. Exclusion criteria: 1. Those with pharyngeal symptoms or inflammation caused by measles, scarlet fever, agranulocytosis, infectious mononucleosis, influenza, diphtheria, acute epiglottitis, acute carotid arteritis, etc.; 2. Those with concurrent acute sinusitis, acute laryngitis, suppurative tonsillitis, bronchitis, pneumonia; 3. Those with a modified Centor score ≥ 2, a body temperature peak \> 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 considered to be bacterial infections by the researcher; 4. Those with concurrent severe primary diseases of the cardiovascular and cerebrovascular system, liver, kidney, hematopoietic system, endocrine system, and mental diseases; 5. Those with a history of thyroid - related diseases such as hyperthyroidism and hypothyroidism; 6. Those with laboratory test results

Вмешательства

• Препарат Qinqiao Yanshu Granules
  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 a

Первичные конечные точки

• The disappearance rate of pharyngeal pain 3 and 5 days after treatment [Срок оценки: 3days/5days]

Критерии участия

Критерии включения

• 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.

Критерии исключения

• 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 suspected bacterial infection considered by the researcher.
• 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, etc.) within 48 hours before this visit.
• 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.

Критерии приведены из реестра в оригинале (на английском). Окончательную оценку соответствия проводит исследовательский центр.

Здоровые добровольцы: Нет

Дизайн исследования

Распределение

Рандомизированное

Модель

Параллельные группы

Маскирование

Четверное слепое

Основная цель

Лечение

Центры проведения

Китай · 7 центров

• The First Affiliated Hospital of Heilongjiang University of Chinese Medicine — Харбин
• The First Affiliated Hospital of Hunan University of Chinese Medicine — Чанша
• Affiliated Hospital of Changchun University of Chinese Medicine — Changchun
• Affiliated Hospital of Shandong University of Traditional Chinese Medicine — Цзинань
• The Affiliated Traditional Chinese Medicine Hospital of Southwest Medical University — Luzhou
• First Affiliated Hospital of Tianjin University of Traditional Chinese Medicine — Тяньцзинь
• Wenzhou Hospital of Traditional Chinese Medicine — Wenzhou

Идентификаторы

NCT: NCT06932328 · JM-2024-04

Первоисточники (государственные реестры)

• ClinicalTrials.gov (NIH, США)

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