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临床试验/NCT06650917
NCT06650917已完成1 期

Explore the Application Effect of Acupoint Massage Combined With Ear Point Pressing Beans in the Remission Stage of Asthma

Hai'an Hospital of TCM0010 个研究点目标入组 120 人开始时间: 2016年1月1日最近更新:
适应症

试验速览

阶段
1 期
状态
已完成
发起方
入组人数
120
主要终点
Pulmonary function

研究概览

简要总结

Objective: To explore the application effect of acupoint massage combined with ear point pressing beans in the remission stage of asthma. Methods: 120 children with asthma in remission who were treated in pediatric outpatient department from January 2016 to October 2022 were randomly divided into experimental group and control group, with 60 cases in each group.The patients in both groups were treated with salmeterol and fluticasone inhalation powder once a day, twice a day. The patients in the control group were treated with acupoint massage on this basis. Acupoint massage once a day from Monday to Friday, lasting for 30 minutes each time.The patients in the experimental group were treated with ear point pressing beans on the basis of the control group. The ear point pressing beans is performed once a day from Monday to Friday. Changes in pulmonary function and asthma control were observed before and after treatment in the two groups were observed, and forced expiratory volume 1 second (FEV1),forced expiratory vital capacity (FVC), FEV1/FVC, asthma control test scale (ACT) score were compared.

研究设计

研究类型
Interventional
分配方式
Randomized
干预模型
Parallel
主要目的
Treatment
盲法
Single (Participant)

入排标准

年龄范围
1 Year 至 18 Years(Child, Adult)
性别
All
接受健康志愿者

入选标准

  • The patient met the diagnostic criteria of asthma remission in the Guidelines for prevention and treatment of bronchial asthma;
  • 1~18 years old, course of disease > 1 year;
  • Patients with complete clinical data and able to cooperate with treatment.

排除标准

  • Patients with other cardiopulmonary system diseases or myasthenia gravis;
  • Eczema, ulcer or other symptoms in the auricle or skin;
  • Illiteracy, cognitive, language or communication disorders;
  • The patient has taken medication for asthma treatment within 3 months.

结局指标

主要结局

Pulmonary function

时间窗: 1 minutes

Forced expiratory vital capacity (FVC), FEV 1 and FEV1/FVC ratio were measured with Jaeger pulmonary function testing instrument

Asthma control

时间窗: 1 hour

The Asthma Control test Scale (ACT) was used for assessment, including daily life status, dyspnea times, asthma symptoms, emergency medication use, and asthma control. Each item was 1 to 5 points, and the total score was 5 to 25 points.

Efficacy assessment

时间窗: 1 hour

Complete control: no symptoms occurred throughout the day after treatment, no significant limitation of activity, no acute attack, PEF or FEV1 normal value or ≥ normal expected value; Partial control: after treatment, symptoms\> 2 times/week during the day, wake up at night, mild limitation of activity. Drug relief is required for over 2 times/week; Uncontrolled: frequent symptoms during the day and at night, limited activity, acute attacks. Drugs should be used frequently for relief. Total control rate = complete control rate + partial control rate.

次要结局

未报告次要终点

研究者

发起方
Hai'an Hospital of TCM001
申办方类型
Other
责任方
Principal Investigator
主要研究者

Xiaohong Chu

Deputy Chief Chinese Medicine Practitioner

Hai'an Hospital of TCM001

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