研究疾病:
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外周动脉疾病
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研究疾病代码:
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Target disease:
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peripheral arterial disease
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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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探索性研究/预试验
Pilot clinical trial
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研究目的:
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1 评价软坚清脉颗粒(Ruan Jian Qing Mai granule, RJQM)对下肢动脉硬化闭塞症(atherosclerosis obliterans, ASO)血运重建术后患者临床终点事件发生的影响;
2 观察RJQM对ASO血运重建术后患者下肢动脉灌注情况及促血管新生相关细胞因子水平的影响;
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Objectives of Study:
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1 To evaluate the effect of Ruanjian Qingmai granule (RJQM) on the occurrence of clinical endpoint events in patients with lower limb atherosclerosis obliterans (ASO) after revascularization;
2 To observe the effects of RJQM on the perfusion of lower limb arteries and the levels of pro-angiogenic related cytokines in patients after ASO revascularization;
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药物成份或治疗方案详述:
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软坚清脉颗粒(Ruan Jian Qing Mai granule, RJQM)和安慰剂均由上海练塘药业有限公司在标准生产规范指导下统一生产,其中安慰剂的口味、气味、规格及包装等与RJQM一致。RJQM由垂盆草、生蒲黄、豨莶草、煅牡蛎和海藻组成,每袋为6g;安慰剂为原方十分之一有效成分制剂,每袋6g。RJQM及安慰剂每天服用两次,每次一包,早饭餐后将颗粒溶解于适量温水中口服,持续治疗12周。研究过程中,受试者需要停止使用其他能够缓解症状的中成药或汤药,包括口服制剂和注射制剂。同时,受试者在每次随访中应提供现阶段用药记录、治疗和不良反应,以检查依从性和纠正偏差。症状加重时允许使用不到2周的救急药物,这需要记录在病例报告表(case report form, CRF)中。
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Description for medicine or protocol of treatment in detail:
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Ruanjian Qingmai granule (RJQM) and placebo were produced by Shanghai Liantang Pharmaceutical Co., Ltd. under the guidance of standardized production norms, in which the taste, smell, specification and packaging of placebo were the same as that of RJQM, which consisted of stringy stonecrop herb, cattail pollen, glandularstalk st., Calcined Oyster and Seaweed, with a size of 6g; and placebo was the preparation of one-tenth of the active ingredient of the original formula, with 6g in each bag. One-tenth of the active ingredient preparation, 6 g per sachet.RJQM and placebo were taken twice a day, one sachet each time, with the granules dissolved in a moderate amount of warm water orally after the morning meal, for 12 weeks of continuous treatment. During the course of the study, subjects were required to discontinue the use of other proprietary Chinese medicines or tonics capable of relieving symptoms, including oral and injectable preparations. Meanwhile, subjects should provide a record of current medication use, treatment and adverse reactions at each follow-up visit to check compliance and correct deviations. The use of rescue medication for less than 2 weeks is allowed in case of symptom exacerbation, which needs to be recorded in the case report form (CRF).
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纳入标准:
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(1)接受血运重建术前的临床资料符合中华医学会外科学分会血管外科学组编撰的《下肢动脉硬化闭塞症诊治指南2016》中ASO诊断标准,同时符合中华人民共和国中医药行业标准《中医内科病症诊断疗效标准》(ZY/T001.1-94)中脱疽的诊断标准;(2)40<年龄≤90周岁,性别不限;(3)近6个月内已行下肢血运重建术;(4)同意参加本临床试验并自愿签署知情同意书。
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Inclusion criteria
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(1) Clinical data before undergoing revascularization meet the diagnostic criteria of PAD in the Guidelines for Diagnosis and Treatment of Lower Extremity Atherosclerotic Occlusive Disease 2016 compiled by the Vascular Surgery Group of the Surgery Branch of the Chinese Medical Association, as well as meet the diagnostic criteria of desmoplasia in the Diagnostic Efficacy Criteria for Chinese Medicine Internal Medicine Disease (ZY/T001.1-94) of the Chinese People's Republic of China Traditional Chinese Medicine Industry Standard; (2) 40 < age ≤ 90 years old, gender is not limited; (3) have undergone lower limb revascularization within the last 6 months; (4) agree to participate in this clinical trial and voluntarily sign the informed consent.
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排除标准:
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(1)急性下肢缺血计划进行下肢血管重建者以及存在大截肢史的患者;(2)股总以上、股髂动脉闭塞、腹股沟以上动脉闭塞的患者;(3)炎症性血管疾病患者,如多发性大动脉炎、血栓闭塞性脉管炎等非下肢动脉粥样硬化闭塞症;(4)近3个月内出现肺栓塞、心肌梗死、严重的心功能衰竭*、短暂性脑缺血发作或急性缺血性卒中等缺血事件的患者;(5)对RJQM过敏;(6)随机化前存在严重的肝肾功能不全、恶性肿瘤、精神异常、妊娠或备孕等研究者认为不适宜参加本研究的患者;(7)近6个月内参与过其它药物临床试验者。
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Exclusion criteria:
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(1) patients with acute lower extremity ischemia scheduled for lower extremity revascularization and those with a history of major amputation; (2) patients with occlusion of the common femoral or above, femoro-iliac arteries, or occlusion of the arteries above the groin; (3) patients with inflammatory vascular diseases such as atherosclerotic occlusions of the non-lower extremity arteries such as multiple large arteritis, thrombo-occlusive vasculitis, and others; (4) patients who have had a pulmonary embolism in the last 3 months, a myocardial infarction, severe cardiac failure, transient ischemic attack or acute ischemic stroke and other ischemic events in the past 3 months; (5) allergy to RJQM; (6) the presence of severe hepatic or renal insufficiency, malignant tumors, mental anomalies, pregnancy, or preparation for pregnancy prior to randomization, and other patients considered by the investigator as unsuitable for participation in this study; and (7) those who have been involved in a clinical trial of other drugs in the past 6 months.
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研究实施时间:
Study execute time:
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从From
2023-09-15
至To
2024-09-15
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征募观察对象时间:
Recruiting time:
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从From
2023-09-15
至To
2024-03-15
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