[Translation] A multi-center, randomized, double-blind, placebo-controlled phase III clinical trial of the effectiveness and safety of Huanglian Jiedu Pills in the treatment of Excessive Heat and Fire Toxin Syndrome
(1)评价黄连解毒丸治疗中医实热火毒证的有效性。
评价指标:实热火毒证有效率,急性咽炎、复发性口腔溃疡、牙龈炎、便秘实热火毒证有效率,主要症状消失率,主要症状消失时间,实热火毒证单项证候评分较基线变化值,咽喉疼痛VAS评分较基线的变化值,复发性口腔溃疡疼痛VAS评分较基线的变化值,牙龈炎SBI分级评分较基线的变化情况,血样、尿样和唾液样本生物标记物较基线的变化情况。
(2)观察黄连解毒丸临床应用的安全性。
观察指标:不良事件/反应发生率,实验室检查,生命体征等。
[Translation] (1) To evaluate the effectiveness of Huanglian Jiedu Pills in the treatment of excess heat and fire-toxin syndrome in traditional Chinese medicine.
Evaluation indicators: effective rate of excess-heat-fire-toxin syndrome, acute pharyngitis, recurrent oral ulcer, gingivitis, constipation, excess-heat-fire-toxin syndrome effective rate, disappearance rate of main symptoms, main symptom disappearance time, change of single syndrome score of excess-heat-fire-toxin syndrome compared with baseline Changes from baseline in VAS scores for sore throat, changes in VAS scores for recurrent oral ulcer pain from baseline, changes in SBI grading score for gingivitis, changes in biomarkers in blood, urine and saliva samples from baseline Condition.
(2) To observe the safety of the clinical application of Huanglian Jiedu Pills.
Observation indicators: incidence of adverse events/reactions, laboratory tests, vital signs, etc.