研究疾病:
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急性咽炎
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研究疾病代码:
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Target disease:
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Acute pharyngitis
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Target disease code:
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研究类型:
Study type:
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干预性研究
Interventional study
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研究设计:
Study design:
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随机平行对照
randomized controlled trial(parallel group design)
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研究所处阶段:
Study phase:
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上市后药物
Post-marketing clinical trial
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研究目的:
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评价连花清瘟颗粒治疗急性咽炎的有效性和安全性
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Objectives of Study:
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Evaluation of the efficacy and safety of Lianhua Qingwen granules in the treatment of acute pharyngitis
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药物成份或治疗方案详述:
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成 份:连翘、金银花、炙麻黄、炒苦杏仁、石膏、板蓝根、绵马贯众、鱼腥草、广藿香、大黄、红景天、薄荷脑、甘草
试验组:连花清瘟颗粒, 口服,一次1袋,一日3次;
安慰剂组:连花清瘟颗粒模拟剂,口服,一次1袋,一日3次。
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Description for medicine or protocol of treatment in detail:
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Ingredients: Forsythia suspensa, honeysuckle, roasted ephedra, fried bitter almond, gypsum, isatis indigotica, Dryopterygium japonicum, houttuynia cordata, Patchouli, rhubarb, Rhodiola rosea, menthol, liquorice
Experimental group: Lianhua Qingwen Granules, taken orally, 1 bag at a time, 3 times a day;
Placebo group: Lianhua Qingwen Granule Simulator, oral, 1 bag per time, 3 times per day.
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纳入标准:
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1)符合西医急性咽炎诊断;
2)年龄在 18~65 周岁(包含两端边界值),性别不限;
3)入组前,研究者评估咽痛VAS评分≥4;
4)病程 ≤48h者(此处定义为患者出现急性咽炎症状和体征如咽痛、咽部红肿距本次就诊的时间不超过48小时);
5)自愿参加临床试验并签署知情同意书。
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Inclusion criteria
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1) Conforming to the diagnosis of acute pharyngitis in Western medicine;
2) Age range from 18 to 65 years old (including boundary values at both ends), regardless of gender;
3) Before enrollment, the researcher evaluated the pharyngeal pain VAS score to be ≥ 4;
4) Patients with a course of disease ≤ 48 hours (defined here as patients who experience symptoms and signs of acute pharyngitis such as sore throat and swollen throat within 48 hours of this visit);
5) Volunteer to participate in clinical trials and sign an informed consent form.
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排除标准:
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1)腋下体温>38.5℃者;
2)血白细胞计数>12×109/L 者;
3)入组时,存在腹泻(便溏)者;
4)合并支气管炎、肺炎、化脓性扁桃体炎,或因麻疹、猩红热、流感、粒细胞缺乏、传染性单核细胞增多症、白血病、急性颈动脉炎等引发的咽部症状或炎症者;
5)肝功能 ALT、AST 超过参考值上限 1.5 倍,或 Scr 超过参考值上限者;
6)合并心脑血管、肝、肾、造血系统、内分泌系统等严重原发性疾病或精神病患者;
7)过敏体质( 对2类以上物质过敏者),及对本研究药物(包括安慰剂)已知成分、任何辅料过敏者;
8)妊娠或计划妊娠,或在试验期间不能严格避孕者,哺乳期妇女;
9)怀疑或确有酒精、药物滥用史者;
10)一个月内参加过其他临床试验者。
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Exclusion criteria:
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1) Those with an armpit temperature greater than 38.5 ℃;
2) White blood cell count>12 × 109/L;
3) Individuals with diarrhea (loose stools) during enrollment;
4) Patients with bronchitis, pneumonia, suppurative Tonsillitis, or pharyngeal symptoms or inflammation caused by measles, Scarlet fever, influenza, agranulocytosis, infectious Monocyte, leukemia, acute carotid arteritis, etc;
5) Liver function ALT and AST exceed the upper limit of the reference value by 1.5 times, or Scr exceeds the upper limit of the reference value;
6) Patients with serious primary diseases or psychosis such as cardiovascular, cerebrovascular, liver, kidney, hematopoietic system, Endocrine system;
7) Allergic constitution (those who are allergic to Class 2 or more substances), as well as those who are allergic to known ingredients or any excipients of the study drug (including placebo);
8) Pregnant or planned pregnancies, or those who cannot strictly control contraception during the trial period, lactating women;
9) Suspected or with a history of alcohol or drug abuse;
10) Individuals who have participated in other clinical trials within a month.
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研究实施时间:
Study execute time:
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从From
2023-02-01
至To
2024-12-31
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征募观察对象时间:
Recruiting time:
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从From
2023-07-07
至To
2024-09-30
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