研究疾病:
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变应性鼻炎
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研究疾病代码:
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Target disease:
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allergic rhinitis(AR)
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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.初步观察长疗程穴位贴敷治疗持续性 AR 的疗效和安全性,为开展大规模临床研究的奠定基础。
2.若临床观察结果显示中药穴位贴敷有效,了解长疗程穴位贴敷对 AR 持续性炎症状态的影响及探讨相关的免疫学机制。
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Objectives of Study:
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1. To observe the efficacy and safety of long-term acupoint application in the treatment of persistent AR, so as to lay a foundation for large-scale clinical research.
2. If clinical observation shows that acupoint application of Chinese medicine is effective, to understand the effect of long-term acupoint application on the persistent inflammatory of AR and to explore the relevant immunological mechanism.
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药物成份或治疗方案详述:
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治疗选穴:纳入 AR 患者均为虚证者(肺、脾、肾三脏任一脏亏虚或多脏亏虚),结合文献报道和我院临床专家的意见,按顺序轮流选用以下两组穴位:①肺俞、百劳、脾俞、肾俞;②风门、大椎、中府、水分、关元、中脘。 若 AR 急性发作:在①组选穴基础上鼻痒喷嚏涕多加风门,鼻塞加大椎;在②组选穴基础上鼻痒喷嚏加心俞;涕多加脾俞;鼻塞加百劳,以上背部穴位均取双侧。
治疗时间:庚日贴(10 天 1 次),若有事不能按时治疗,尽量在庚日前后 1-2天贴,每次贴敷时间最长 1 小时,或者以患者不能耐受时取出贴敷药物,连续治疗半年。
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Description for medicine or protocol of treatment in detail:
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Treatment acupoints: Participants will be the AR patients with deficiency syndrome (Lung, Spleen or Kidney deficiency, two or more aforementioned organs dificiency). Combined with literature reports and the opinions of clinical experts in our hospital, the following two groups of acupoints will be selected in turn: (1) Feishu, Bailao, Pishu, Shenshu; (2) Fengmen, Dazhui, Zhongfu, Shuifen, Guanyuan, Zhongwan. If AR acute attack: on the basis of acupoints in group 1, participant with nasal itching and sneezing will add Fengmen, participant with nasal congestion will add Dazhui; on the basis of acupoints in group 2, participant with nasal itching and sneezing will add Xinshu; participant with lots of nasal congestion will add Pishu; participant with nasal congestion will add Bailao, the above acupoints on the back will be apply both sides.
Treatment time: Every Geng Day (once every 10 days) during the treatment period. If subjects cannot be treated on time, they will be to apply 1-2 days before and after Geng Day. Each time subjects will apply a maximum of 1 hour, or take out when the subject cannot stand it. This treatment will last six months.
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纳入标准:
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1) 符合 AR 中西诊断标准者,中医辨证为虚证(肺、脾、肾三脏任一脏亏虚或多脏亏虚)。
2) 年龄 18-65 岁,性别不限。
3) 参试者需知情同意,志愿参加研究。
4) 能够按要求完成病例观察表等相关记录和配合随访和(或)等待。
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Inclusion criteria
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1) Meet the Chinese and western diagnostic criteria of AR, Chinese Medicine syndrome differentiation is deficiency syndrome (Lung, Spleen or Kidney deficiency, two or more aforementioned organs dificiency).
2) 18 to 65 years old, no gender limited.
3) Participants need informed consent and volunteer to participate the study.
4) Be able to complete relevant records such as case report form and cooperate with follow-up and / or waiting as required.
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排除标准:
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1) 急性鼻炎(伤风),血管运动性鼻炎,自主神经性鼻炎,嗜酸性粒细胞增多性非变态反应性鼻炎,变应性鼻窦炎。
2) 胶布过敏者。
3) 局部皮肤病变如烧伤、湿疹、溃疡、冻疮破溃,难以愈合者。
4) 孕妇,若研究过程中发现怀孕者,暂停试验;妇女月经期暂停(经后可补贴,但应注明贴敷日期)。
5) 由于智力或行为障碍不能充分配合试验和调查者。
6) 因工作环境等原因经常变动等易造成失访的患者。
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Exclusion criteria:
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1) Participants who have suffered rhinitis (cold), vasomotor rhinitis, autonomic rhinitis, eosinophilic non-allergic rhinitis, allergic sinusitis.
2) Participants who are allergic to adhesive tape.
3) Participants who have difficult to heal local skin lesions such as burns, eczema, ulcers and frostbite.
4) Pregnant women, if they are found to be pregnant during the study, suspend the test; women's menstruation is suspended (it can be subsidized after menstruation, but the date of application should be indicated).
5) Participants who can not fully cooperate with the experimenters and investigators,due to mental or behavioral disorders.
6) Participants who are easy to lose follow-up due to frequent changes in working environment and other reasons.
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研究实施时间:
Study execute time:
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从From
2021-12-31
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
2022-05-23
至To
2023-11-30
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