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首页> 外文期刊>Phytomedicine : >Double-blind, placebo-controlled, randomized, pilot clinical trial of ImmunoGuard--a standardized fixed combination of Andrographis paniculata Nees, with Eleutherococcus senticosus Maxim, Schizandra chinensis Bail. and Glycyrrhiza glabra L. extracts
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Double-blind, placebo-controlled, randomized, pilot clinical trial of ImmunoGuard--a standardized fixed combination of Andrographis paniculata Nees, with Eleutherococcus senticosus Maxim, Schizandra chinensis Bail. and Glycyrrhiza glabra L. extracts

机译：ImmunoGuard的双盲，安慰剂对照，随机，试验性临床试验-穿心莲的标准固定组合，与西番莲肠球菌Maxim，北五味子保释。和甘草提取物

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Double blind, randomized, placebo controlled pilot study of ImmunoGuard--a standardized fixed combination of Andrographis paniculata Nees., Eleutherococcus senticosus Maxim., Schizandra chinensis Bail., and Glycyrrhiza glabra L. special extracts standardized for the content of Andrographolide (4 mg/tablet), Eleuteroside E, Schisandrins and Glycyrrhizin, was carried out in two parallel groups of patients. The study was conducted in 24 (3-15 years of both genders) patients with Familial Mediterranean Fever (FMF), 14 were treated with tablets of series A (verum) and 10 patients received series B product (placebo). The study medication was taken three times of four tablets daily for 1 month. Daily dose of the andrographolide--48 mg. The primary outcome measures in physician's evaluation were related to duration, frequency and severity of attacks in FMF patients (attacks characteristics score). The patient's self-evaluation was based mainly on symptoms--abdominal, chest pains, temperature, arthritis, myalgia, erysipelas-like erythema. All of 3 features (duration, frequency, severity of attacks) showed significant improvement in the verum group as compared with the placebo. In both clinical and self evaluation the severity of attacks was found to show the most significant improvement in the verum group. Both the clinical and laboratory results of the present phase II (pilot) clinical study suggest that ImmunoGuard is a safe and efficacious herbal drug for the management of patients with FMF.
机译：对ImmunoGuard进行双盲，随机，安慰剂对照的先导研究-穿心莲，穿刺肠球菌，五味子和甘草的标准化固定组合，为穿心莲内酯（4 mg / g在两组平行患者中进行了Eleuteroside E，五味子苷和甘草甜素的治疗。这项研究是针对24例（两性3-15岁的）地中海家族性热病（FMF）的患者进行的，其中14例接受了A系列片剂（普通）治疗，而10例接受了B系列产品（安慰剂）治疗。每天服用4片三剂的研究药物，共1个月。穿心莲内酯的每日剂量-48毫克。医师评估中的主要结局指标与FMF患者发作的持续时间，发作频率和严重程度（攻击特征评分）有关。患者的自我评估主要基于以下症状：腹部，胸痛，体温，关节炎，肌痛，丹毒样红斑。与安慰剂相比，verum组的所有3个特征（持续时间，频率，发作的严重程度）均显示出显着改善。在临床和自我评估中，发现攻击的严重程度在verum组中显示出最显着的改善。当前II期（试验）临床研究的临床和实验室结果均表明，ImmunoGuard是用于治疗FMF患者的安全有效的草药。

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